|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03241875 |
|
Date of registration:
|
29/07/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy
|
|
Scientific title:
|
Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy. A Randomized Clinical Trial |
|
Date of first enrolment:
|
December 1, 2016 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03241875 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Tunisia
| | | | | | | |
|
Contacts
|
|
Name:
|
Mohamed Said Nakhli, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Faculty of Medicine, Sousse |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- uncomplicated laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) status < 3
Exclusion Criteria:
- acute cholecystitis
- conversion to open cholecystectomy
- history of epilepsia, psychiatric disorders and cognitive impairment
- Pregnancy and breastfeeding
- allergy to pregabalin and/or gabapentin
- Chronic pain
- Chronic medication by corticosteroids, neuroleptics or non steroidal anti inflammatory
drugs
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cholecystectomy, Laparoscopic
|
|
Pain, Postoperative
|
|
Intervention(s)
|
|
Drug: Gabapentin 300mg
|
|
Drug: Placebo oral capsule
|
|
Drug: Pregabalin 75mg
|
|
Primary Outcome(s)
|
|
Post operative shoulder pain
[Time Frame: VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery]
|
|
Secondary Outcome(s)
|
|
Post operative sleep quality during the first night
[Time Frame: first night after surgery]
|
|
remifentanil consumption during anesthesia
[Time Frame: one hour after tracheal tube removal]
|
|
Post operative nausea and vomiting
[Time Frame: 2, 6, 12, 24 and 48 hours after surgery.]
|
|
Secondary ID(s)
|
|
Nakhli anesthesia sahloul
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|