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study specific patients are now scheduled at another hospital for this procedure
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This study is being done to compare 2 types of pain control methods and determine which is more effective postoperatively for laparoscopic colorectal surgery. Group 1 will receive an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid. Group 2 will receive an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
All laparoscopic colorectal cases were scheduled by colorectal surgeons at IU Health University or Methodist Hospital and were identified using medical records. The subjects were contacted face-to-face prior to surgery. They were informed about the study and questions were answered. The potential subjects were given a copy of the informed consent form and authorization form. The subjects were contacted face-to-face in Pre-Operative Care Unit on the day of surgery and if they decided to participate, written consent was taken.
In the Intrathecal group, intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 18-75 years of age and duramorph 150 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 76- 80 years of age.
In the ESP group, a patient was given a bilateral ESP block at thoracic vertebrae level 10 (T10). This was placed under ultrasound using 30 ml of 0.25% bupivacaine and 4 mg of Decadron.
Randomization will be performed using Research Randomizer. The primary investigator informed the person doing the regional techniques as to what group the patients were randomized to. Neither the patients and the research staff doing assessments will be blinded to the randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IT Injection | Active Comparator | an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid |
|
| ESP Block | Active Comparator | an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IT Injection | Drug | an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Cumulated Oral Morphine Equivalent (OME) | 24 hour cumulated oral morphine consumption (OME) | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Morphine Equivalents (OME) | Oral Morphine Equivalents consumed | 1 hour after surgery |
| Oral Morphine Equivalents (OME) | Oral Morphine Equivalent consumption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any contraindication for neuraxial analgesia or ESP block procedure
Any patient undergoing a laparoscopic abdominoperineal resection.
Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
Known true allergy to the study medications (morphine, bupivacaine, decadron, Tylenol, Celebrex)
Takes over 30 mg of oral morphine equivalents daily
Any history of substance abuse in the past 6 months
End stage liver disease, end stage renal disease
Body weight of < 50 kg
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| Name | Affiliation | Role |
|---|---|---|
| Amy McCutchan, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18650627 | Background | Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a. | |
| 28097305 | Background | Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IT Injection | an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid |
| FG001 | ESP Block | an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back. ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IT Injection | an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 24 Hour Cumulated Oral Morphine Equivalent (OME) | 24 hour cumulated oral morphine consumption (OME) | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Mean | Standard Deviation | mg morphine equivalents | 24 hours after surgery |
|
We followed adverse events for 72 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IT Injection | an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| spinal headache | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy McCutchan | Indiana University | 317-274-0275 | almccutc@iu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2021 | Feb 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| ESP Block | Drug | an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back |
|
|
| 12 hours after surgery |
| Oral Morphine Equivalents (OME) | Oral Morphine Equivalent consumption | 24 hours after surgery |
| Oral Morphine Equivalents (OME) | Oral Morphine Equivalent consumption | 48 hours after surgery |
| Oral Morphine Equivalents (OME) | Oral Morphine Equivalent Consumption | 72 hours after surgery |
| Visual Analog Scale Pain Scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | 1 hour after surgery |
| Visual Analog Scale Pain Scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | 12 hours after surgery |
| Visual Analog Scale Pain Scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | 24 hours after surgery |
| Visual Analog Scale Pain Scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | 48 hours after surgery |
| Visual Analog Scale Pain Scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | 72 hours after surgery |
| First Ambulation | Time to patient first ambulation | Duration of hospital stay up to 72 hours |
| First Flatus | Time to first flatus | Duration of hospital stay up to 72 hours |
| Oral Liquid | Time to first oral liquid intake | Duration of hospital stay up to 72 hours |
| Oral Food | Time to first oral food intake | Duration of hospital stay up to 72 hours |
| Hospital Length of Stay | Amount of time each subject spends in the hospital before discharge | Duration of hospital stay up to 7 days |
| Patient's Satisfaction Scores | Assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied) | 24 hours after surgery |
| Patient's Satisfaction Scores | Assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied) | 48 hours after surgery |
| Number of Participants With Side Effects | Incidence of urinary retention, ileus, spinal headache, pruritis, respiratory depression, injection site infection, nerve damage, hematoma, pneumothorax, lower extremity weakness. | Duration of hospital stay up to 72 hours |
| Nausea | point in time of which had nausea | Duration of hospital stay up to 72 hours |
| 24781574 | Background | Miller TE, Thacker JK, White WD, Mantyh C, Migaly J, Jin J, Roche AM, Eisenstein EL, Edwards R, Anstrom KJ, Moon RE, Gan TJ; Enhanced Recovery Study Group. Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg. 2014 May;118(5):1052-61. doi: 10.1213/ANE.0000000000000206. |
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| 19841366 | Background | Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170. |
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| 27642630 | Background | Borzellino G, Francis NK, Chapuis O, Krastinova E, Dyevre V, Genna M. Role of Epidural Analgesia within an ERAS Program after Laparoscopic Colorectal Surgery: A Review and Meta-Analysis of Randomised Controlled Studies. Surg Res Pract. 2016;2016:7543684. doi: 10.1155/2016/7543684. Epub 2016 Aug 24. |
| 25436285 | Background | Liu H, Hu X, Duan X, Wu J. Thoracic epidural analgesia (TEA) vs. patient controlled analgesia (PCA) in laparoscopic colectomy: a meta-analysis. Hepatogastroenterology. 2014 Jul-Aug;61(133):1213-9. |
| 29687077 | Background | Merchea A, Lovely JK, Jacob AK, Colibaseanu DT, Kelley SR, Mathis KL, Spears GM, Huebner M, Larson DW. Efficacy and Outcomes of Intrathecal Analgesia as Part of an Enhanced Recovery Pathway in Colon and Rectal Surgical Patients. Surg Res Pract. 2018 Mar 1;2018:8174579. doi: 10.1155/2018/8174579. eCollection 2018. |
| 32660719 | Background | Koning MV, Klimek M, Rijs K, Stolker RJ, Heesen MA. Intrathecal hydrophilic opioids for abdominal surgery: a meta-analysis, meta-regression, and trial sequential analysis. Br J Anaesth. 2020 Sep;125(3):358-372. doi: 10.1016/j.bja.2020.05.061. Epub 2020 Jul 11. |
| 26395762 | Background | Day AR, Smith RV, Scott MJ, Fawcett WJ, Rockall TA. Randomized clinical trial investigating the stress response from two different methods of analgesia after laparoscopic colorectal surgery. Br J Surg. 2015 Nov;102(12):1473-9. doi: 10.1002/bjs.9936. Epub 2015 Sep 23. |
| 21590762 | Background | Levy BF, Scott MJ, Fawcett W, Fry C, Rockall TA. Randomized clinical trial of epidural, spinal or patient-controlled analgesia for patients undergoing laparoscopic colorectal surgery. Br J Surg. 2011 Aug;98(8):1068-78. doi: 10.1002/bjs.7545. Epub 2011 May 17. |
| 27005290 | Background | Pedrazzani C, Menestrina N, Moro M, Brazzo G, Mantovani G, Polati E, Guglielmi A. Local wound infiltration plus transversus abdominis plane (TAP) block versus local wound infiltration in laparoscopic colorectal surgery and ERAS program. Surg Endosc. 2016 Nov;30(11):5117-5125. doi: 10.1007/s00464-016-4862-5. Epub 2016 Mar 22. |
| 32122319 | Background | Liu X, Song T, Chen X, Zhang J, Shan C, Chang L, Xu H. Quadratus lumborum block versus transversus abdominis plane block for postoperative analgesia in patients undergoing abdominal surgeries: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Mar 2;20(1):53. doi: 10.1186/s12871-020-00967-2. |
| 33106280 | Background | Dam M, Hansen C, Poulsen TD, Azawi NH, Laier GH, Wolmarans M, Chan V, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block reduces opioid consumption and prolongs time to first opioid demand after laparoscopic nephrectomy. Reg Anesth Pain Med. 2021 Jan;46(1):18-24. doi: 10.1136/rapm-2020-101745. Epub 2020 Oct 26. |
| 32290814 | Background | Huang J, Liu JC. Ultrasound-guided erector spinae plane block for postoperative analgesia: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Apr 14;20(1):83. doi: 10.1186/s12871-020-00999-8. |
| 32357842 | Background | Kendall MC, Alves L, Traill LL, De Oliveira GS. The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 May 1;20(1):99. doi: 10.1186/s12871-020-01016-8. |
| 32439926 | Background | Kwon HM, Kim DH, Jeong SM, Choi KT, Park S, Kwon HJ, Lee JH. Does Erector Spinae Plane Block Have a Visceral Analgesic Effect?: A Randomized Controlled Trial. Sci Rep. 2020 May 21;10(1):8389. doi: 10.1038/s41598-020-65172-0. |
| 28272292 | Background | Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581. |
| 27501016 | Background | Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. |
| Background | López MB, Cadórniga ÁG, González JML, Suárez ED, Carballo CL, Sobrino FP. Erector spinae block. A narrative review. Cent Eur J Clin Res. 2018;1(1):28-39 |
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| 30621377 | Background | De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4. |
| 31695476 | Background | Tulgar S, Ahiskalioglu A, De Cassai A, Gurkan Y. Efficacy of bilateral erector spinae plane block in the management of pain: current insights. J Pain Res. 2019 Aug 27;12:2597-2613. doi: 10.2147/JPR.S182128. eCollection 2019. |
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| 30426190 | Background | Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y. |
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| 22588748 | Background | Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available. |
| ESP Block |
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back. ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| weight | Mean | Standard Deviation | kg |
|
| OG001 |
| ESP Block |
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back. ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back |
|
|
| Secondary | Oral Morphine Equivalents (OME) | Oral Morphine Equivalents consumed | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Least Squares Mean | Standard Error | mg morphine equivalents | 1 hour after surgery |
|
|
|
| Secondary | Oral Morphine Equivalents (OME) | Oral Morphine Equivalent consumption | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Least Squares Mean | Standard Error | mg morphine equivalents | 12 hours after surgery |
|
|
|
| Secondary | Oral Morphine Equivalents (OME) | Oral Morphine Equivalent consumption | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Least Squares Mean | Standard Error | mg morphine equivalents | 24 hours after surgery |
|
|
|
| Secondary | Oral Morphine Equivalents (OME) | Oral Morphine Equivalent consumption | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Least Squares Mean | Standard Error | mg morphine equivalents | 48 hours after surgery |
|
|
|
| Secondary | Oral Morphine Equivalents (OME) | Oral Morphine Equivalent Consumption | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Least Squares Mean | Standard Error | mg morphine equivalents | 72 hours after surgery |
|
|
|
| Secondary | Visual Analog Scale Pain Scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Least Squares Mean | Standard Error | score on a scale | 1 hour after surgery |
|
|
|
| Secondary | Visual Analog Scale Pain Scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 hours after surgery |
|
|
|
| Secondary | Visual Analog Scale Pain Scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Least Squares Mean | Standard Error | score on a scale | 24 hours after surgery |
|
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| Secondary | Visual Analog Scale Pain Scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Least Squares Mean | Standard Error | score on a scale | 48 hours after surgery |
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| Secondary | Visual Analog Scale Pain Scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Least Squares Mean | Standard Error | score on a scale | 72 hours after surgery |
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| Secondary | First Ambulation | Time to patient first ambulation | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Mean | Standard Deviation | Hours | Duration of hospital stay up to 72 hours |
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| Secondary | First Flatus | Time to first flatus | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Mean | Standard Deviation | Hours | Duration of hospital stay up to 72 hours |
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| Secondary | Oral Liquid | Time to first oral liquid intake | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Mean | Standard Deviation | Hours | Duration of hospital stay up to 72 hours |
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| Secondary | Oral Food | Time to first oral food intake | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Mean | Standard Deviation | Hours | Duration of hospital stay up to 72 hours |
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| Secondary | Hospital Length of Stay | Amount of time each subject spends in the hospital before discharge | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Mean | Standard Deviation | days | Duration of hospital stay up to 7 days |
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| Secondary | Patient's Satisfaction Scores | Assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied) | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Count of Participants | Participants | 24 hours after surgery |
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| Secondary | Patient's Satisfaction Scores | Assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied) | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control | Posted | Count of Participants | Participants | 48 hours after surgery |
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| Secondary | Number of Participants With Side Effects | Incidence of urinary retention, ileus, spinal headache, pruritis, respiratory depression, injection site infection, nerve damage, hematoma, pneumothorax, lower extremity weakness. | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Number | participants | Duration of hospital stay up to 72 hours |
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| Secondary | Nausea | point in time of which had nausea | The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control. | Posted | Count of Participants | Participants | Duration of hospital stay up to 72 hours |
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| 0 |
| 56 |
| 0 |
| 56 |
| 7 |
| 56 |
| EG001 | ESP Block | an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back. ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back | 0 | 51 | 0 | 51 | 2 | 51 |
| urinary retention | Renal and urinary disorders | Systematic Assessment |
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| ileus | Gastrointestinal disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| Neutral |
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| Unsatisfied |
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| Very Unsatisfied |
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| Neutral |
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| Unsatisfied |
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| Very Unsatisfied |
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| pruritis |
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| respiratory depression |
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| injection site infection |
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| nerve damage |
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| hematoma |
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| pneumothorax |
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| lower extremity weakness |
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| spinal headache |
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| mild |
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| none |
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| 12 hours after surgery |
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| 24 hours after surgery |
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| 48 hours after surgery |
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| 72 hours after surgery |
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