Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Postoperative Trendelenburg Position on Shoulder Pain After Gynecological Laparoscopic Procedures.

Conditions
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Shoulder Pain

Intervention / Treatment
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* Procedure: 20 degree Trendelenburg position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients Age: 18 years to 60 years, American Society of Anesthesiologist physical status (ASA) 1 or 2 Diagnostic or operative gynecologic laparoscopy {4 port sites, three 5 mm trocars (suprapubic, right and left iliac fossa) and one 10 mm trocar (umbilical)} between one and 3 hours duration. Abdominal incisions less than 1.5 cm. Steady abdominal insufflation pressure of 14 mm Hg following a gradual insufflation over a 5-minute period. Insufflation at a steady maximal flow of 30 l/min Exclusion Criteria: Conversion to laparotomy. Abdominal insufflation pressure more than 14 mm Hg. Medical drug allergy to paracetamol, ketoprofen and/or tramadol. Presence of gastro-esophageal reflux (GERD) Pregnancy Patient with Thrombophilias and or at high risk of Deep Vein Thrombosis (DVT) Obesity body mass index (BMI) greater than 40 One day surgery patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group S<br>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). | |
| Experimental: Group T<br>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<br>* The patients in the intervention group will be placed in trendelenburg position postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder pain (12 hours) | Pain score (measured using a 0-10 numerical scale) at 12 hours | 12 hours after laparoscopic surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder pain | Pain score (measured using a 0-10 numerical scale) | 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) | 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) | at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery | 
| Rescue pain medication | Time to first rescue pain medication (minutes) | within first 24 hours after laparoscopic surgery | 
| Total rescue pain medication | Total rescue pain medication during first 24 hours | within first 24 hours after laparoscopic surgery | 
| Patient satisfaction | Patient satisfaction with surgical experience (measured using a 0-10 numerical scale) | 24 hours post laparoscopic surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, shoulder pain, trendelenburg position