Clinical Trials Directory

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

TypeNameDescription
PROCEDURE20 degree Trendelenburg positionThe 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.