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Enhanced Recovery After Laparoscopic Colorectal Surgery

NCT ID: NCT05406765

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-10-07

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.

Conditions

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Rectal Cancer Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Randomization, allocation, and blinding: Randomization will be conducted by using sealed, opaque envelopes. An independent colleague at the Clinical Research Department will randomize these envelopes in blocks of 5. These envelopes will be stacked and stored outside the operating room. The upper envelope will be opened by the attending anesthesiologist when an included patient arrives in the operating theater. The patient, surgical team, nurses on the ward, and researcher team will be blinded. Only the attending anesthetic team will be aware of the randomization. They will be instructed not to tell the patient or any other health care worker which group the patient was allocated to.

Study Groups

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Spinal

Spinal anesthesia

Group Type ACTIVE_COMPARATOR

Bupivacaine Injection

Intervention Type DRUG

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

Placebo

Placebo spinal

Group Type PLACEBO_COMPARATOR

Bupivacaine Injection

Intervention Type DRUG

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

Interventions

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Bupivacaine Injection

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

Intervention Type DRUG

Other Intervention Names

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Marcain

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars M Ytrebø, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway

Locations

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University Hospital of North Norway

Tromsø, Troms, Norway

Site Status

Countries

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Norway

References

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Antunes M, Baumgartel A, Gjessing PF, Ytrebo LM. Spinal Anaesthesia as an Adjunct to General Anaesthesia for Laparoscopic Abdominoperineal Rectal Amputation. J Pain Res. 2023 May 31;16:1855-1865. doi: 10.2147/JPR.S410019. eCollection 2023.

Reference Type DERIVED
PMID: 37284327 (View on PubMed)

Other Identifiers

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Project 2805

Identifier Type: -

Identifier Source: org_study_id