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OpenTrials
Completed

NCT Number: NCT05406765

Enhanced Recovery After Laparoscopic Colorectal Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine Injection

Drug

One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally

Other names: Marcain

Primary outcomes

  1. Nummeric rating scale (0-10), where 10 indicate worst possible pain.

    Time frame: 48 hours after surgery

    Worst pain scores in the first 48 hrs.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 6, 2022
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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