American University of Beirut Medical Center
Beirut, 1103, Lebanon
NCT Number: NCT04129385
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.
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Notify Me18 year–60 year
Female
Interventional
Not applicable
Beirut, 1103, Lebanon
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patients in the intervention group will be placed in trendelenburg position postoperatively.
Time frame: 12 hours after laparoscopic surgery
Pain score (measured using a 0-10 numerical scale) at 12 hours
Time frame: at arrival to post anesthesia care unit (PACU), 4, 6, and 24 hours, after laparoscopic surgery
Pain score (measured using a 0-10 numerical scale)
Time frame: at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Presence or absence of nausea (yes/no)
Time frame: at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Nausea score (measured using a 0-10 numerical scale)
Time frame: within first 24 hours after laparoscopic surgery
Time to first rescue pain medication (minutes)
Time frame: within first 24 hours after laparoscopic surgery
Total rescue pain medication during first 24 hours
Time frame: 24 hours post laparoscopic surgery
Patient satisfaction with surgical experience (measured using a 0-10 numerical scale)
American University of Beirut Medical Center
Other
Effect of Postoperative Trendelenburg Position on Shoulder Pain After Gynecological Laparoscopic Procedures.
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