Clinical trial NCT06182111: Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy
Official title: Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy - a Retrospective, Observational, Quality-improvement Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Pain
Morphine
Laparoscopic Cholecystectomy
Keywords: Intraoperative morphine for laparoscopic cholecystectomy
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgery performed at Hospital og South West Jutland, Esbjerg in main operating facilities.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of rescue analgesia.
timeFrame: 24 hours
Secondary outcomes:
measure: Intraoperative opioid use.
timeFrame: 24 hours
measure: Pain-score at arrival in postoperative ward.
timeFrame: 24 hours
measure: Pain-score at discharge from postoperative ward.
timeFrame: 24 hours
measure: Rescue antiemetic treatment in postoperative ward.
timeFrame: Up to 24 hours follow up.
measure: Time in postoperative ward.
timeFrame: 24 hours
measure: Analgesic treatment in surgical ward if admitted
timeFrame: 24 hours
measure: Antiemetic treatment in surgical ward.
timeFrame: 24 hours
measure: Hospital length of stay.
timeFrame: 1 month
measure: Emergence from anesthesia.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of south West Jutland
Study officials:
affiliation: Esbjerg Hospital - University Hospital of Southern Denmark
name: Sanne V Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References: