Colon Cancer, Rectal Cancer, Colonic Diverticulosis
Conditions
Keywords
Continuous Epidural Analgesia, Transversus Abdominis Plane block
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURETAP Block
This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
PROCEDUREContinuous Epidural Analgesia
Epidural catheter placed prior to the operation in the standard fashion
Sponsors
Trinity Health Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective open and minimally invasive (laparoscopic and robotic) colon and rectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectum; * Surgical procedure either through standard open or minimal invasive approach (laparoscopic or robotic); * Patients \> 18 years of age; * Able to provide informed written consent * Patients capable of completing questionnaires at the time of consent
Exclusion criteria
* Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl; * Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated International Normalized Ratio (INR), anticoagulation, patient refusal, etc) or TAP block (patient refusal); * Urgent or emergent surgery precluding epidural catheter placement or TAP block; * Systemic Infection contraindicating epidural catheter placement or TAP block; * Unwillingness to participate in follow up assessments; * Prisoners * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Mean Numeric Pain Scale. | Post-operative day 0,1,2,3 | 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. |
| Overall Benefits of Analgesia Score (OBAS) | Post-operative day 0,1,2,3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Use of Narcotic Analgesia Post-op Day 0 | Post-operative day 0 | Patient use of narcotic analgesia post-operative day 0 including Fentanyl from epidural |
| Patient Use of Narcotic Analgesia Post-operative Day 0 | Post-operative day 0 | Patient use of narcotic analgesia post operative day 0 excluding Fentanyl from epidural. |
| Patient Use of Narcotic Analgesia Post-operative Day 3 | Post-operative day 3 | Patient use of narcotic analgesia post-operative day 3 including Fentanyl from epidural |
| Patient Use of Narcotic Analgesia Post-operative Day 1 | Post-operative day 1 | Patient use of narcotic analgesia post operative day 1 including Fentanyl from epidural |
| Patient Use of Narcotic Analgesia Post-operative Day 2 | Post-operative day 2 | Patient use of narcotic analgesia post operative day 2 including Fentanyl from epidural |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert K Cleary, MD
Saint Joseph Mercy Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.05 years STANDARD_DEVIATION 11.45 |
| Alcohol use | 2 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) | 3 Participants |
| Congestive heart failure | 4 Participants |
| Coronary artery disease | 19 Participants |
| Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) | 8 Participants |
| Diabetes mellitus | 15 Participants |
| Disseminated cancer | 10 Participants |
| Hypertension | 48 Participants |
| Opioid use | 1 Participants |
| Previous abdominal surgery | 30 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black | 14 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants |
| Race/Ethnicity, Customized White | 77 Participants |
| Region of Enrollment United States | 179 participants |
| Renal disease | 2 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 50 Participants |
| Sleep apnea | 8 Participants |
| Steroids use | 2 Participants |
| Tobacco use | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 92 |
| other Total, other adverse events | 0 / 87 | 0 / 92 |
| serious Total, serious adverse events | 0 / 87 | 0 / 92 |
Outcome results
None listed