Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative morphine.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Morphine, Laparoscopic Cholecystectomy. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy - a Retrospective, Observational, Quality-improvement Study
Overview
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.
Interventions
- Procedure Intraoperative morphine
Morphine dose = 0,1 mg mg/kg (maximum 10 mg) intravenous given 20 min after start of surgery
Primary outcome measures
- Use of rescue analgesia. [Time frame: 24 hours]
Secondary outcome measures (9)
- Intraoperative opioid use. [Time frame: 24 hours]
- Pain-score at arrival in postoperative ward. [Time frame: 24 hours]
- Pain-score at discharge from postoperative ward. [Time frame: 24 hours]
- Rescue antiemetic treatment in postoperative ward. [Time frame: Up to 24 hours follow up.]
- Time in postoperative ward. [Time frame: 24 hours]
- Analgesic treatment in surgical ward if admitted [Time frame: 24 hours]
- Antiemetic treatment in surgical ward. [Time frame: 24 hours]
- Hospital length of stay. [Time frame: 1 month]
- Emergence from anesthesia. [Time frame: 24 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Hospital of south West Jutland — Esbjerg
Identifiers
NCT: NCT06182111 · 23/47526