Enhanced Recovery After Laparoscopic Colorectal Surgery

Study Overview
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Brief Summary
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Investigators would like to test the effects of spinal anesthesia as an adjunct to general anesthesia in patients undergoing laparoscopic abdominoperineal rectal amputation. Investigators hypothesize that spinal anesthesia as an adjunct to general anesthesia will reduce postoperative pain and opioid requirements.

Detailed Description
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Effective pain management after laparoscopic rectal surgery is a fundamental requirement in an enhanced recovery after surgery program (ERAS). Opioids remain the mainstay for postsurgical pain despite well documented side effects including sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression. Spinal analgesia as an adjunct to general anesthesia has not been studied in laparoscopic rectal surgery, but data from studies of patients undergoing colon cancer resection indicate a positive analgesic effect of spinal anesthesia as an adjunct to general anesthesia. When an ERAS program was used for laparoscopic colonic resection, It has been showed that an intrathecal mixture of bupivacaine and morphine was associated with less postoperative opioid consumption. In a more recent paper intrathecal morphine was a more effective method for treating postoperative pain in laparoscopic colon surgery than intravenous opioids within an ERAS program. In the present proposal the investigators would like to test the effects of spinal anesthesia as an adjunct to general anesthesia in patients undergoing laparoscopic abdominoperineal rectal amputation. It was hypothesized that spinal anesthesia as an adjunct to general anesthesia would reduce postoperative pain and opioid requirements.

Official Title
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Spinal Analgesia for Laparoscopic Abdominoperineal Rectal Amputation Using an Enhanced Recovery After Surgery Program: a Randomized Double-blind Placebo-controlled Trial

Conditions
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Rectal Cancer, Postoperative Pain

Intervention / Treatment
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* Drug: Bupivacaine Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria *All patients undergoing laparoscopic abdominoperineal rectal amputation for rectal cancer * Age 18-100 years are eligible for enrollment in the study. Exclusion Criteria ASA IV, BMI>35, contraindication to spinal analgesia allergy to any of the drugs used in this study protocol, chronic use of opioids or steroids, liver or renal impairment, patients scheduled for synchronous laparoscopic liver metastatic surgery inability to communicate in Norwegian.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal<br>Spinal anesthesia | Drug: Bupivacaine Injection<br>* One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally<br>* Other names: Marcain;|
| Placebo Comparator: Placebo<br>Placebo spinal | Drug: Bupivacaine Injection<br>* One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally<br>* Other names: Marcain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nummeric rating scale (0-10), where 10 indicate worst possible pain. | Worst pain scores in the first 48 hrs. | 48 hours after surgery |