An observational study in Postoperative Pain, Morphine and Laparoscopic Cholecystectomy, sponsored by Esbjerg Hospital - University Hospital of Southern Denmark. Status unknown at 1 site in Denmark. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Esbjerg Hospital - University Hospital of Southern Denmark · Observational
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:
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.
5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 622 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Esbjerg Hospital - University Hospital of Southern Denmark is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Surgery performed at Hospital og South West Jutland, Esbjerg in main operating facilities.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants who have undergone surgery before anesthesia protocol was changed. These participants have not received morphine during surgery.
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
Use of rescue analgesia.
Calculated as morphine equivalents.
Time frame: 24 hours
Intraoperative opioid use.
Calculated as morphine equivalents.
Time frame: 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).
Time frame: 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).
Time frame: 24 hours
Rescue antiemetic treatment in postoperative ward.
Antiemetic drugs and doses registered.
Time frame: Up to 24 hours follow up.
Time in postoperative ward.
Minutes.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours
Hospital length of stay.
Only if admitted (a large proportion of patients are expected to undergo out-patient procedure).
Time frame: 1 month
Emergence from anesthesia.
Surrogate measure of emergence from anesthesia time.
Time frame: 24 hours
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — 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.
Started Jun 2024 (actual). Primary completion is estimated for May 2025, 11 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Esbjerg Hospital - University Hospital of Southern Denmark