NCT05406765

Enhanced Recovery After Laparoscopic Colorectal Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Rectal Cancer
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine Injection	One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-10-07
• Completion: 2022-10-07
• First posted: 2022-06-06
• Last updated: 2022-12-22

Locations

1 site across 1 country: Norway