Trials / Completed
CompletedNCT04129385
Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position
Effect of Postoperative Trendelenburg Position on Shoulder Pain After Gynecological Laparoscopic Procedures.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- American University of Beirut Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
Laparoscopic surgery has become a standard of care for many gynecological surgeries due to its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of carbon dioxide (CO2) to insufflate the abdomen is a major contributor to post operative shoulder pain. Shoulder pain post laparoscopy is common and it is a major cause of patient dissatisfaction. The aim of our study is to evaluate the efficacy of positioning the patient in Trendelenburg, post operatively for 24 hours, on shoulder pain reduction. Our hypothesis is based on the assumption that complete CO2 deflation is not possible and that Trendelenburg positioning will help displace CO2 from the sub diaphragmatic area thus reducing the diaphragmatic and phrenic nerve irritation causing pain.
Detailed description
A prospective randomized controlled study with 54 patients in each of the two arms. Group S (control) will undergo the standard laparoscopic procedure and the patients will be placed in supine head up position postoperatively. In group T (interventional); the patients will be positioned in Trendelenburg position once fully awake and cooperative in the post-anesthesia case unit (PACU) and will remain in this position for the first 24 hours postoperatively. Postoperative NRS(numeric rating scale) score for shoulder pain and nausea will be collected at arrival to PACU, \& 4, 6, 12 and 24 hours postoperatively. In addition, total amount of rescue pain and nausea medication used by the patient will be recorded. Data collected will be analyzed and compared between the two groups. The independent t- test will be used to compare postoperative shoulder pain, with NRS scores treated as continuous variable, between the two groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 20 degree Trendelenburg position | The patients in the intervention group will be placed in trendelenburg position postoperatively. |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2018-06-20
- Completion
- 2018-06-28
- First posted
- 2019-10-16
- Last updated
- 2019-10-16
Locations
1 site across 1 country: Lebanon
Source: ClinicalTrials.gov record NCT04129385. Inclusion in this directory is not an endorsement.