Laparoscopic Cholecystectomy, Morphine, Postoperative Pain
Conditions
Keywords
Intraoperative morphine for laparoscopic cholecystectomy
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.
Interventions
PROCEDUREIntraoperative morphine
Morphine dose = 0,1 mg mg/kg (maximum 10 mg) intravenous given 20 min after start of surgery
Sponsors
Esbjerg Hospital - University Hospital of Southern Denmark
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of rescue analgesia. | 24 hours | Calculated as morphine equivalents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Rescue antiemetic treatment in postoperative ward. | Up to 24 hours follow up. | Antiemetic drugs and doses registered. |
| Time in postoperative ward. | 24 hours | Minutes. |
| Intraoperative opioid use. | 24 hours | Calculated as morphine equivalents. |
| 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. |
| 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. |
| 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. |
Countries
Denmark
Contacts
Primary ContactSanne V Nielsen, MD
Backup ContactJonas L Herping, MD
Outcome results
None listed