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NCT05428982 Clinical Trial

The Effect of Postoperative Modified Trendelenburg Position to Decrease Shoulder Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial

Shoulder Pain Clinical Trial

Official title:
The Effect of Postoperative Modified Trendelenburg Position to Decrease Shoulder Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05428982
Other study ID # 65055
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2022
Est. completion date August 30, 2023

Study information
Verified date July 2023
Source Rajavithi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Laparoscopic surgery is commonly used procedure in diagnostic and treatment including Hysterectomy. Post laparoscopic shoulder pain is common side effect mostly occur after surgery. Postoperative Trendelenburg position might decrease pain by reducing the mechanical pressure of CO2 on the diaphragm. Maintaining the patient in Trendelenburg for 6 hours postoperatively will decrease postoperative shoulder pain.

Description:

After laparoscopic hysterectomy surgery, Patients in intervention group were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours because of the limitation of this study cannot positioned in Trendelenburg position. A modified Trendelenburg position is head and trunk of patient were in neutral position while hips and lower extrimities were raised at 20 degree. In control group were in neutral position. All patients were asked shoulder pain score at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: - Female patient age between 30-65 years - American Society of Anesthesiologist (ASA) physical status I or II - Scheduled for operative laparoscopic hysterectomy with abdominal incisions measuring less than 1 cm in size - Can speak and understand Thai language Exclusion Criteria: - Pregnant women - Conversion procedure to open abdominal surgery - Patients with postoperative abdominal drainage - Surgery duration more than 3 hours - Gynecologic malignancy surgery - Patients with history of chronic shoulder pain - Patients with history of previous shoulder surgery - Inability to accurately express pain - Patients with history of Gastroesophageal reflux disease or chronic gastritis - Patients with history of cardiovascular or pulmonary disease - Patients with history of venous thrombosis - Morbid obesity BMI > 40 kg/m2 - Patients with history of increase intracranial pressure - Patients with history of increase intraocular pressure - Patients with liver and/or kidney disease - NSAIDs and/or Paracetamol and/or Morphine allergy - Current corticosteroid use - Patients who use current analgesic drugs and don't want to quit while stay in the hospital - Psychiatric disorder - Intellectual disorder - Postoperative length in hospital less than 24 hours

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Postoperative Modified Trendelenburg position
Patients underwent the laparoscopic hysterectomy were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours at ward.

Locations
Country Name City State
Thailand Rajavithi Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of shoulder pain score Comparison of shoulder pain score at 6 hours after postoperative Modified Trendelenburg position for 6 hours Using Numerical rating scale 0-10, 0 mean no pain, 10 mean worst pain at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Secondary Comparison of nausea vomiting score Comparison of nausea vomiting score at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours Nausea vomiting score grading : 1. None mean no symptom, 2. Mild mean only nausea, not required antiemetic drugs 3.Moderate mean have symptom of nausea and vomiting and required antiemetic drugs 4.Severe mean have symptom of nausea and vomiting and required antiemetic drugs more than 1 time at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Secondary Total amount of antiemetic drugs in 24 hours postoperatively Total amount of antiemetic drugs in 24 hours postoperatively 24 hours postoperatively
Secondary Comparison of upper abdominal pain score Comparison of upper abdominal pain score at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours Using Numerical rating scale 0-10, 0 mean no pain, 10 mean worst pain at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Secondary Comparison of lower abdominal pain score Comparison of lower abdominal pain score at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours Using Numerical rating scale 0-10, 0 mean no pain, 10 mean worst pain at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
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