Status:
COMPLETED
Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position
Lead Sponsor:
American University of Beirut Medical Center
Conditions:
Shoulder Pain
Eligibility:
FEMALE
18-60 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2018
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04129385
Start Date
March 1 2016
End Date
June 28 2018
Last Update
October 16 2019
Active Locations (1)
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1
American University of Beirut Medical Center
Beirut, Lebanon, 1103