Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy
- Conditions
- Laparoscopic CholecystectomyPostoperative PainMorphine
- Interventions
- Procedure: Intraoperative morphine
- Registration Number
- NCT06182111
- Lead Sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- patients who have had elective laparoscopic cholecystectomy/planned gall-bladder removal surgery
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Morphine Intraoperative morphine Participants who have undergone surgery after anesthesia protocol was changed. These participants have received morphine during surgery.
- Primary Outcome Measures
Name Time Method Use of rescue analgesia. 24 hours Calculated as morphine equivalents.
- Secondary Outcome Measures
Name Time Method Rescue antiemetic treatment in postoperative ward. Up to 24 hours follow up. Antiemetic drugs and doses registered.
Pain-score at arrival in postoperative ward. 24 hours 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).
Pain-score at discharge from postoperative ward. 24 hours 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).
Time in postoperative ward. 24 hours Minutes.
Analgesic treatment in surgical ward if admitted 24 hours Only if admitted (a large proportion of patients expected to undergo out-patient procedure). Calculated as morphine equivalents.
Intraoperative opioid use. 24 hours Calculated as morphine equivalents.
Hospital length of stay. 1 month Only if admitted (a large proportion of patients are expected to undergo out-patient procedure).
Emergence from anesthesia. 24 hours Surrogate measure of emergence from anesthesia time.
Antiemetic treatment in surgical ward. 24 hours Only if admitted (a large proportion of patients are expected to undergo out-patient procedure). Antiemetic drugs and doses registered.
Trial Locations
- Locations (1)
Hospital of south West Jutland
🇩🇰Esbjerg, Denmark