Enhanced Recovery After Laparoscopic Colorectal Surgery

University Hospital of North Norway

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Rectal Cancer

Treatments: Drug: Bupivacaine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05406765

Project 2805

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Spinal

Active Comparator group

Description:

Spinal anesthesia

Treatment:

Drug: Bupivacaine Injection

Placebo

Placebo Comparator group

Description:

Placebo spinal

Treatment:

Drug: Bupivacaine Injection