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The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a hysterectomy surgery. By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (nausea, sedation, ileus, urinary retention, respiratory depression).
For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected. [10]
For the ESP block, as mentioned previously, the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected.
All patients will receive PO acetaminophen and PO gabapentin the morning of surgery. Pt. will be placed on PRN oxycodone/acetaminophen (Percocet) postoperatively. PRN IV dilaudid may be given for severe breakthrough pain.
Opioid usage at 1, 24 and 48 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24 and 48 hours after the blocks and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESP Block | Active Comparator | For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) |
|
| TAP Block | Active Comparator | For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | 20ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour. | Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10) | 1 hour after surgery |
| Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours. | Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain (scale 0-10) | 24 hours after surgery |
| Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours. | Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain(scale 0-10) | 48 hours after surgery |
| Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour. | Visual Analogue Scale (VAS) score taken with movement is measured as minimal to maximal; higher values mean worse pain (scale 0-10) | 1 hour after surgery |
| Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours. | Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain (scale 0-10) | 24 hours after surgery |
| Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours. | Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain(scale 0-10) | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Sedation Score at 1 Hour | Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep) | 1 hour after surgery |
| Patient Sedation Score at 24 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yar Yeap, MD | Indiana University Hospital | Principal Investigator |
| Matthew Warner, MD | Indiana University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Univeristy | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27830448 | Result | Shaffer EE, Pham A, Woldman RL, Spiegelman A, Strassels SA, Wan GJ, Zimmerman T. Estimating the Effect of Intravenous Acetaminophen for Postoperative Pain Management on Length of Stay and Inpatient Hospital Costs. Adv Ther. 2017 Jan;33(12):2211-2228. doi: 10.1007/s12325-016-0438-y. Epub 2016 Nov 9. | |
| 27856266 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | ESP Block | For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml |
| FG001 | TAP Block | For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ESP Block | For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml |
| 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 | Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour. | Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10) | Posted | Mean | Standard Error | score on a scale | 1 hour after surgery |
|
From the time of consent up to 6 months after surgery.
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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 | ESP Block | For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12) Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yar Yeap | Indiana University School of Medicine | (317) 274-0275 | yyeap@iupui.edu |
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| 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 | Apr 23, 2018 | Mar 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Both the patients and the research staff doing assessments will be blinded to the randomization
| bupivacaine, 0.125% | Drug | 60ml |
|
|
Sedation is measured as minimum to maximum aware ness/level of consciousness: higher values means worse or less awareness (awake, asleep but arousable, deep sleep) |
| 24 hours after surgery |
| Patient Sedation Score at 48 Hours | Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep) | 48 hours after surgery |
| Patient Nausea Score at 1 Hour | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) | 1 hour after surgery |
| Patient Nausea Score at 24 Hour | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) | 24 hour after surgery |
| Patient Nausea Score at 48 Hour | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) | 48 hour after surgery |
| Patient Satisfaction Score at 24 Hours | patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied) | 24 hours after surgery |
| Patient Satisfaction Score at 48 Hours | patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied) | 48 hours after surgery |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Routman HD, Israel LR, Moor MA, Boltuch AD. Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Apr;26(4):641-647. doi: 10.1016/j.jse.2016.09.033. Epub 2016 Nov 15. |
| 29723644 | Result | Bacal V, Rana U, McIsaac DI, Chen I. Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):40-52. doi: 10.1016/j.jmig.2018.04.020. Epub 2018 Apr 30. |
| 30292068 | Result | Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3. |
| 30288093 | Result | Petsas D, Pogiatzi V, Galatidis T, Drogouti M, Sofianou I, Michail A, Chatzis I, Donas G. Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a case report. J Pain Res. 2018 Sep 24;11:1983-1990. doi: 10.2147/JPR.S164489. eCollection 2018. |
| 27501016 | Result | 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. |
| 27673545 | Result | Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547. |
| 27035853 | Result | Hadzic A, Minkowitz HS, Melson TI, Berkowitz R, Uskova A, Ringold F, Lookabaugh J, Ilfeld BM. Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty. Anesthesiology. 2016 Jun;124(6):1372-83. doi: 10.1097/ALN.0000000000001117. |
| 27443874 | Result | Wu ZQ, Min JK, Wang D, Yuan YJ, Li H. Liposome bupivacaine for pain control after total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2016 Jul 22;11(1):84. doi: 10.1186/s13018-016-0420-z. |
| 36214314 | Derived | Warner M, Yeap YL, Rigueiro G, Zhang P, Kasper K. Erector spinae plane block versus transversus abdominis plane block in laparoscopic hysterectomy. Pain Manag. 2022 Nov;12(8):907-916. doi: 10.2217/pmt-2022-0037. Epub 2022 Oct 10. |
| BG001 | TAP Block | For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | 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 |
|
| TAP Block |
For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml |
|
|
| Primary | Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours. | Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain (scale 0-10) | Posted | Mean | Standard Error | score on a scale | 24 hours after surgery |
|
|
|
| Primary | Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours. | Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain(scale 0-10) | Posted | Mean | Standard Error | score on a scale | 48 hours after surgery |
|
|
|
| Primary | Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour. | Visual Analogue Scale (VAS) score taken with movement is measured as minimal to maximal; higher values mean worse pain (scale 0-10) | Posted | Mean | Standard Error | score on a scale | 1 hour after surgery |
|
|
|
| Primary | Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours. | Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain (scale 0-10) | Posted | Mean | Standard Error | score on a scale | 24 hours after surgery |
|
|
|
| Primary | Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours. | Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain(scale 0-10) | Posted | Mean | Standard Error | score on a scale | 48 hours after surgery |
|
|
|
| Secondary | Patient Sedation Score at 1 Hour | Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep) | Posted | Count of Participants | Participants | 1 hour after surgery |
|
|
|
| Secondary | Patient Sedation Score at 24 Hours | Sedation is measured as minimum to maximum aware ness/level of consciousness: higher values means worse or less awareness (awake, asleep but arousable, deep sleep) | Posted | Count of Participants | Participants | 24 hours after surgery |
|
|
|
| Secondary | Patient Sedation Score at 48 Hours | Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep) | Posted | Count of Participants | Participants | 48 hours after surgery |
|
|
|
| Secondary | Patient Nausea Score at 1 Hour | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) | Posted | Count of Participants | Participants | 1 hour after surgery |
|
|
|
| Secondary | Patient Nausea Score at 24 Hour | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) | Posted | Count of Participants | Participants | 24 hour after surgery |
|
|
|
| Secondary | Patient Nausea Score at 48 Hour | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) | Posted | Count of Participants | Participants | 48 hour after surgery |
|
|
|
| Secondary | Patient Satisfaction Score at 24 Hours | patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied) | Posted | Mean | Standard Error | score on a scale | 24 hours after surgery |
|
|
|
| Secondary | Patient Satisfaction Score at 48 Hours | patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied) | Posted | Mean | Standard Error | score on a scale | 48 hours after surgery |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | TAP Block | For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP). Liposomal bupivacaine: 20ml bupivacaine, 0.125%: 60ml | 0 | 39 | 0 | 39 | 0 | 39 |
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| D000588 |
| Amines |