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

NCT05428982 | Completed DMC

• 1 other identifier: 65055
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Shoulder Pain; Gynecologic Disease

Keywords

Modified Trendelenburg, Shoulder Pain, Laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Comparison of nausea vomiting score

  at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours

• Total amount of antiemetic drugs in 24 hours postoperatively

  24 hours postoperatively

• Comparison of upper 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

Study Arms (2)

Postoperative Modified Trendelenburg group

EXPERIMENTAL

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

Procedure: Postoperative Modified Trendelenburg position

Control

NO INTERVENTION

Patients underwent the laparoscopic hysterectomy were positioned in a neutral position

Interventions

Postoperative Modified Trendelenburg position PROCEDURE

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

Postoperative Modified Trendelenburg group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 23, 2022
• Study Start: June 30, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-07

Locations

TH (1)