Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain, Morphine, Laparoscopic Cholecystectomy

Intervention / Treatment
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* Procedure: Intraoperative morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No morphine<br>Participants who have undergone surgery before anesthesia protocol was changed. These participants have not received morphine during surgery. | |
| Morphine<br>Participants who have undergone surgery after anesthesia protocol was changed. These participants have received morphine during surgery. | Procedure: Intraoperative morphine<br>* Morphine dose = 0,1 mg mg/kg (maximum 10 mg) intravenous given 20 min after start of surgery<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative morphine for laparoscopic cholecystectomy