An interventional study of 20 degree Trendelenburg position in Shoulder Pain, sponsored by American University of Beirut Medical Center. Completed at 1 site in Lebanon. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-10-16.
Sponsored by American University of Beirut Medical Center · Not applicable, Interventional, and Prevention
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.
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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 108 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Control group (Group S: 54 patients); this group will undergo the standard laparoscopic procedure (the procedure is done in Trendelenburg position). While in Trendelenburg position and prior to wound closure and with laparoscopic port valves open, the patient's abdomen will be passively deflated. The patients will be placed in supine head up position in the post anesthesia care unit (PACU).
Intervention group (Group T: 54 patients); the patients will be subject to the same maneuver as in arm 1 prior to wound closure but will be positioned in a 20 degree Trendelenburg position once fully awake and cooperative in the PACU and will remain in this position for the first 24 hours post operatively, even after they are transferred to their rooms on the American University of Beirut Medical Center (AUBMC) floors. The maximum time allowed in a straight-up position will be three 15-minute intervals over a 24-hour period (the first interval being a clear fluids intake at 12 hours postoperatively).
Procedure: 20 degree Trendelenburg position
The patients in the intervention group will be placed in trendelenburg position postoperatively.
Shoulder pain (12 hours)
Pain score (measured using a 0-10 numerical scale) at 12 hours
Time frame: 12 hours after laparoscopic surgery
Shoulder pain
Pain score (measured using a 0-10 numerical scale)
Time frame: at arrival to post anesthesia care unit (PACU), 4, 6, and 24 hours, after laparoscopic surgery
Presence of nausea
Presence or absence of nausea (yes/no)
Time frame: at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Severity of Nausea
Nausea score (measured using a 0-10 numerical scale)
Time frame: at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Rescue pain medication
Time to first rescue pain medication (minutes)
Time frame: within first 24 hours after laparoscopic surgery
Total rescue pain medication
Total rescue pain medication during first 24 hours
Time frame: within first 24 hours after laparoscopic surgery
Patient satisfaction
Patient satisfaction with surgical experience (measured using a 0-10 numerical scale)
Time frame: 24 hours post laparoscopic surgery
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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American University of Beirut Medical Center