Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy

NCT06182111 | Recruiting DMC

• 1 other identifier: 23/47526
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational, quality improvement study is to compare the effect of a dose of morphine given during gall-bladder removal surgery. The main questions to answer are:

• Do participants, who are given given a dose of morphine during gall-bladder removal surgery, experience less pain after surgery?
• Does a dose of morphine during gall-bladder removal surgery cause more side effects? The investigators will compare the effects of two types of anesthesia: a) anesthesia without morphine during surgery, and b) anesthesia with morphine during surgery.

Conditions

Postoperative Pain; Morphine; Laparoscopic Cholecystectomy

Keywords

Intraoperative morphine for laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Use of rescue analgesia.

  Calculated as morphine equivalents.

  24 hours

Secondary Outcomes (9)

• Intraoperative opioid use.

  24 hours

• Pain-score at arrival in postoperative ward.

  24 hours

• Pain-score at discharge from postoperative ward.

  24 hours

• Rescue antiemetic treatment in postoperative ward.

  Up to 24 hours follow up.

• Time in postoperative ward.

  24 hours

Study Arms (2)

No morphine

Participants who have undergone surgery before anesthesia protocol was changed. These participants have not received morphine during surgery.

Morphine

Participants who have undergone surgery after anesthesia protocol was changed. These participants have received morphine during surgery.

Procedure: Intraoperative morphine

Interventions

Intraoperative morphine PROCEDURE

Morphine dose = 0,1 mg mg/kg (maximum 10 mg) intravenous given 20 min after start of surgery

Morphine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgery performed at Hospital og South West Jutland, Esbjerg in main operating facilities.

You may qualify if:

• patients who have had elective laparoscopic cholecystectomy/planned gall-bladder removal surgery

You may not qualify if:

• age limit as above
• patients unable to give consent to anesthesia
• patients unable to participate in pain scoring
• patients with chronic pain syndromes, characterized by patients receiving regular analgesic treatment and patients with active or previous contact to pain clinic)
• patients with active or previous substance abuse
• emergency surgery

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (1)

Hospital of south West Jutland

Esbjerg, 6700, Denmark

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sanne V Nielsen, MD

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanne V Nielsen, MD

CONTACT

+45 28 49 18 25 (private); sanne.vibe.nielsen@rsyd.dk

Jonas L Herping, MD

CONTACT

jonal.l.e.herping2@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 26, 2023
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

DK (1)