Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

— MORPHLAPCHOL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06182111
• Other study ID #: 23/47526
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: December 2023
• Source: Hospital of South West Jutland
• Contact: Sanne V Nielsen, MD
• Phone: +45 28 49 18 25 (private)
• Email: sanne.vibe.nielsen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 1, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy
• Morphine
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital of South West Jutland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of rescue analgesia.	Calculated as morphine equivalents.	24 hours
Secondary	Intraoperative opioid use.	Calculated as morphine equivalents.	24 hours
Secondary	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
Secondary	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
Secondary	Rescue antiemetic treatment in postoperative ward.	Antiemetic drugs and doses registered.	Up to 24 hours follow up.
Secondary	Time in postoperative ward.	Minutes.	24 hours
Secondary	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
Secondary	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
Secondary	Hospital length of stay.	Only if admitted (a large proportion of patients are expected to undergo out-patient procedure).	1 month
Secondary	Emergence from anesthesia.	Surrogate measure of emergence from anesthesia time.	24 hours