Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy (MORPHLAPCHOL)

Esbjerg Hospital - University Hospital of Southern Denmark

Status: Enrolling

Conditions: Morphine; Postoperative Pain; Laparoscopic Cholecystectomy

Treatments: Procedure: Intraoperative morphine

Study type: Observational

Funder types: Other

Identifiers

NCT06182111

23/47526

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

No morphine

Description:

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

Morphine

Description:

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

Treatment:

Procedure: Intraoperative morphine