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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Post Operative Pain; Gynecologic Disease
• Intervention / Treatment: Procedure: Postoperative Modified Trendelenburg position

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postoperative Modified Trendelenburg group; Patients underwent the laparoscopic hysterectomy were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours	Procedure: Postoperative Modified Trendelenburg position; Patients underwent the laparoscopic hysterectomy were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours at ward.
No Intervention: Control; Patients underwent the laparoscopic hysterectomy were positioned in a neutral position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total amount of antiemetic drugs in 24 hours postoperatively	Total amount of antiemetic drugs in 24 hours postoperatively	24 hours postoperatively
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
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

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Modified Trendelenburg, Shoulder Pain, Laparoscopic hysterectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain, Postoperative; Shoulder Pain; Genital Diseases, Female
• Other Study ID Numbers: 65055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No