Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy

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

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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The investigators will use Redcap secure web application (via Open Patient Data Explorative Network, a subsidiary under University Hospital of Odense, Denmark) for data collection and data management.

No sample size has been collected as per the observational design. The investigators expect to include an equal number in each study arm, as there has been no indication of change in indications for surgery type.

The investigators expect to use students T-test for comparison of groups. If possible logistic regression analyses will be undertaken.

Conditions

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Postoperative Pain Morphine Laparoscopic Cholecystectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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No morphine

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

No interventions assigned to this group

Morphine

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

Intraoperative morphine

Intervention Type PROCEDURE

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

Interventions

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Intraoperative morphine

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No