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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No morphine | Participants who have undergone surgery before anesthesia protocol was changed. These participants have not received morphine during surgery. | ||
| Morphine | Participants who have undergone surgery after anesthesia protocol was changed. These participants have received morphine during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative morphine | Procedure | Morphine dose = 0,1 mg mg/kg (maximum 10 mg) intravenous given 20 min after start of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Use of rescue analgesia. | Calculated as morphine equivalents. | 24 hours |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Surgery performed at Hospital og South West Jutland, Esbjerg in main operating facilities.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanne V Nielsen, MD | Contact | +45 28 49 18 25 (private) | sanne.vibe.nielsen@rsyd.dk | |
| Jonas L Herping, MD | Contact | jonal.l.e.herping2@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Sanne V Nielsen, MD | Esbjerg Hospital - University Hospital of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of south West Jutland | Recruiting | Esbjerg | 6700 | Denmark |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2023 | Nov 21, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |