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

Not Applicable

Completed

• Conditions: Gynecologic Disease; Post Operative Pain; Shoulder Pain
• Interventions: Procedure: Postoperative Modified Trendelenburg position

• Registration Number: NCT05428982
• Lead Sponsor: Rajavithi Hospital

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Study Start: 2022-06-30
• Status Verified: 2023-07
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postoperative Modified Trendelenburg group	Postoperative Modified Trendelenburg position	Patients underwent the laparoscopic hysterectomy were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours

Primary Outcome Measures

Name	Time	Method
Comparison of shoulder pain score	at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours	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

Secondary Outcome Measures

Name	Time	Method
Comparison of upper abdominal pain score	at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours	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
Comparison of nausea vomiting score	at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours	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
Comparison of lower abdominal pain score	at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours	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
Total amount of antiemetic drugs in 24 hours postoperatively	24 hours postoperatively	Total amount of antiemetic drugs in 24 hours postoperatively

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand