Clinical trial NCT04129385: Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position
Official title: Effect of Postoperative Trendelenburg Position on Shoulder Pain After Gynecological Laparoscopic Procedures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: laparoscopy
shoulder pain
trendelenburg position
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder pain (12 hours)
timeFrame: 12 hours after laparoscopic surgery
Secondary outcomes:
measure: Shoulder pain
timeFrame: at arrival to post anesthesia care unit (PACU), 4, 6, and 24 hours, after laparoscopic surgery
measure: Presence of nausea
timeFrame: at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
measure: Severity of Nausea
timeFrame: at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
measure: Rescue pain medication
timeFrame: within first 24 hours after laparoscopic surgery
measure: Total rescue pain medication
timeFrame: within first 24 hours after laparoscopic surgery
measure: Patient satisfaction
timeFrame: 24 hours post laparoscopic surgery
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Joseph Nassif, M.D.
role: PRINCIPAL_INVESTIGATOR
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