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The primary outcome for this study is the Numeric Pain Score (NPS) for elective patients undergoing elective colorectal surgery that have been randomized to transversus abdominis plane block or epidural anesthesia for the management of perioperative pain in elective colorectal surgery.
Adequate peri-operative analgesia is a vital component of post-operative management for patients undergoing colon and rectal surgery, affecting hospital length of stay, quality of life, and patient outcomes. There are many options for the peri-operative management of pain after elective colorectal surgery.
This is a randomized clinical trial comparing the transversus abdominis plane block using Exparel® to epidural anesthesia for the enhanced recovery pathway perioperative management of pain for elective colorectal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP Block- Exparel | Active Comparator | Transversus abdominis plane block utilizing the medication Exparel® |
|
| Continuous Epidural Analgesia | Active Comparator | Continuous Epidural Analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP Block | Procedure | This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Mean Numeric Pain Scale. | Measured by patient completing the Numeric Pain Scale (NPS) on post-operative day 0,1,2,3. Numeric Pain Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value. | Post-operative day 0,1,2,3 |
| Overall Benefits of Analgesia Score (OBAS) | Measured by the patient completing the OBAS survey on postoperative days 0,1,2,3. The OBAS is a multi-dimensional quality assessment instrument to measure patients' benefit from postoperative pain therapy. 1. Rate your current pain at rest on a scale between 0=minimal pain and 4=maximum imaginable pain 2-6. Grade any distress and bother from vomiting in the past 24 h (0=not at all to 4=very much: same scale for remaining Qs about itching, sweating, freezing, dizziness on the scale). 7. Rate your satisfaction with your pain treatment on a scale between 0=not at all and 4= very much To calculate the OBAS score, compute the sum of scores in items 1-6 and add the '4-(score in item 7)'. The range of scores is from 0 (best) to 28 (worst). Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value. | Post-operative day 0,1,2,3 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Use of Narcotic Analgesia Post-op Day 0 | Patient use of narcotic analgesia post-operative day 0 including Fentanyl from epidural | Post-operative day 0 |
| Patient Use of Narcotic Analgesia Post-operative Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert K Cleary, MD | Saint Joseph Mercy Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30192328 | Derived | Felling DR, Jackson MW, Ferraro J, Battaglia MA, Albright JJ, Wu J, Genord CK, Brockhaus KK, Bhave RA, McClure AM, Shanker BA, Cleary RK. Liposomal Bupivacaine Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colon and Rectal Surgery Enhanced Recovery Pathway: A Randomized Clinical Trial. Dis Colon Rectum. 2018 Oct;61(10):1196-1204. doi: 10.1097/DCR.0000000000001211. |
| Label | URL |
|---|---|
| American Society of Colon and Rectal Surgeons | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Epidural Analgesia | Continuous Epidural Analgesia Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion |
| FG001 | TAP Block- Exparel | Transversus abdominis plane block utilizing the medication Exparel® TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization |
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| Follow-up |
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| Analysis |
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| ID | Title | Description |
|---|---|---|
| BG000 | TAP Block- Exparel | Transversus abdominis plane block utilizing the medication Exparel® TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles |
| BG001 | Continuous Epidural Analgesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age, at consent (years) |
| 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 | Post-operative Mean Numeric Pain Scale. | Measured by patient completing the Numeric Pain Scale (NPS) on post-operative day 0,1,2,3. Numeric Pain Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value. | Posted | Mean | Standard Deviation | units on a scale | Post-operative day 0,1,2,3 |
|
6 months from treatment.
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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 | Continuous Epidural Analgesia | Continuous Epidural Analgesia Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Cleary | St. Joseph Mercy Hospital Ann Arbor | 7347128150 | Robert.Cleary@trinity-health.org |
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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 | Dec 9, 2015 | May 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D043963 | Diverticulosis, Colonic |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Continuous Epidural Analgesia | Procedure | Epidural catheter placed prior to the operation in the standard fashion |
|
Patient use of narcotic analgesia post operative day 0 excluding Fentanyl from epidural.
| Post-operative day 0 |
| Patient Use of Narcotic Analgesia Post-operative Day 3 | Patient use of narcotic analgesia post-operative day 3 including Fentanyl from epidural | Post-operative day 3 |
| Patient Use of Narcotic Analgesia Post-operative Day 1 | Patient use of narcotic analgesia post operative day 1 including Fentanyl from epidural | Post-operative day 1 |
| Patient Use of Narcotic Analgesia Post-operative Day 2 | Patient use of narcotic analgesia post operative day 2 including Fentanyl from epidural | Post-operative day 2 |
| Emergency surgery |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
Continuous Epidural Analgesia Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tobacco use | Count of Participants | Participants |
|
| Alcohol use | Count of Participants | Participants |
|
| Steroids use | Count of Participants | Participants |
|
| Opioid use | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Coronary artery disease | Count of Participants | Participants |
|
| Congestive heart failure | Count of Participants | Participants |
|
| Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
|
| Sleep apnea | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Renal disease | Count of Participants | Participants |
|
| Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) | Count of Participants | Participants |
|
| Disseminated cancer | Count of Participants | Participants |
|
| Previous abdominal surgery | Count of Participants | Participants |
|
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
|
| Primary | Overall Benefits of Analgesia Score (OBAS) | Measured by the patient completing the OBAS survey on postoperative days 0,1,2,3. The OBAS is a multi-dimensional quality assessment instrument to measure patients' benefit from postoperative pain therapy. 1. Rate your current pain at rest on a scale between 0=minimal pain and 4=maximum imaginable pain 2-6. Grade any distress and bother from vomiting in the past 24 h (0=not at all to 4=very much: same scale for remaining Qs about itching, sweating, freezing, dizziness on the scale). 7. Rate your satisfaction with your pain treatment on a scale between 0=not at all and 4= very much To calculate the OBAS score, compute the sum of scores in items 1-6 and add the '4-(score in item 7)'. The range of scores is from 0 (best) to 28 (worst). Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value. | Posted | Mean | Standard Deviation | units on a scale | Post-operative day 0,1,2,3 |
|
|
|
| Secondary | Patient Use of Narcotic Analgesia Post-op Day 0 | Patient use of narcotic analgesia post-operative day 0 including Fentanyl from epidural | Posted | Mean | Full Range | Morphine milligram equivalents | Post-operative day 0 |
|
|
|
| Secondary | Patient Use of Narcotic Analgesia Post-operative Day 0 | Patient use of narcotic analgesia post operative day 0 excluding Fentanyl from epidural. | Posted | Mean | Full Range | Morphine milligram equivalents | Post-operative day 0 |
|
|
|
| Secondary | Patient Use of Narcotic Analgesia Post-operative Day 3 | Patient use of narcotic analgesia post-operative day 3 including Fentanyl from epidural | Posted | Mean | Full Range | Morphine milligram equivalents | Post-operative day 3 |
|
|
|
| Secondary | Patient Use of Narcotic Analgesia Post-operative Day 1 | Patient use of narcotic analgesia post operative day 1 including Fentanyl from epidural | Posted | Mean | Full Range | Morphine milligram equivalents | Post-operative day 1 |
|
|
|
| Secondary | Patient Use of Narcotic Analgesia Post-operative Day 2 | Patient use of narcotic analgesia post operative day 2 including Fentanyl from epidural | Posted | Mean | Full Range | Morphine milligram equivalents | Post-operative day 2 |
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| 0 |
| 87 |
| EG001 | TAP Block- Exparel | Transversus abdominis plane block utilizing the medication Exparel® TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles | 0 | 92 | 0 | 92 | 0 | 92 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |