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

Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy - a Retrospective, Observational, Quality-improvement Study

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Laparoscopic Cholecystectomy; Morphine
• Intervention / Treatment: Procedure: Intraoperative morphine

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Sanne V Nielsen, MD; Phone Number: +45 28 49 18 25 (private); Email: sanne.vibe.nielsen@rsyd.dk
• Study Contact Backup: Name: Jonas L Herping, MD; Email: jonal.l.e.herping2@rsyd.dk

Study Locations

• Denmark
  • Esbjerg, Denmark, 6700
    • Recruiting
    • Hospital of South West Jutland
    • Contact: Sanne Vibe Nielsen, MD; Email: sanne.vibe.nielsen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of rescue analgesia.	Calculated as morphine equivalents.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative opioid use.	Calculated as morphine equivalents.	24 hours
Pain-score at arrival in postoperative ward.	Intervals: 0 = no pain, 1 = light pain (equivalent to numerical ranking scale (NRS) 1-3), 2 = moderate pain (equivalent to NRS 4-6), 3 = severe pain (equivalent to NRS 7-10).	24 hours
Pain-score at discharge from postoperative ward.	Intervals: 0 = no pain, 1 = light pain (equivalent to NRS 1-3), 2 = moderate pain (equivalent to NRS 4-6), 3 = severe pain (equivalent to NRS 7-10).	24 hours
Rescue antiemetic treatment in postoperative ward.	Antiemetic drugs and doses registered.	Up to 24 hours follow up.
Time in postoperative ward.	Minutes.	24 hours
Analgesic treatment in surgical ward if admitted	Only if admitted (a large proportion of patients expected to undergo out-patient procedure). Calculated as morphine equivalents.	24 hours
Antiemetic treatment in surgical ward.	Only if admitted (a large proportion of patients are expected to undergo out-patient procedure). Antiemetic drugs and doses registered.	24 hours
Hospital length of stay.	Only if admitted (a large proportion of patients are expected to undergo out-patient procedure).	1 month
Emergence from anesthesia.	Surrogate measure of emergence from anesthesia time.	24 hours

Collaborators and Investigators

• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
• Investigators: Principal Investigator: Sanne V Nielsen, MD, Esbjerg Hospital - University Hospital of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Intraoperative morphine for laparoscopic cholecystectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 23/47526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

At this time implications of answering in the affirmative are unknown, and description of shared individual participant data (IPD)s cannot be done yet.

However, the investigators fully expect to share anonymized IPD in order to be able to publish the results ogf the study in a peer reviewed journal.