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Completed

NCT Number: NCT05428982

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative Modified Trendelenburg position

Procedure

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

Primary outcomes

  1. Comparison of shoulder pain score

    Time frame: 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 outcomes

  1. Comparison of nausea vomiting score

    Time frame: 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

  2. Total amount of antiemetic drugs in 24 hours postoperatively

    Time frame: 24 hours postoperatively

    Total amount of antiemetic drugs in 24 hours postoperatively

  3. Comparison of upper abdominal pain score

    Time frame: 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

  4. Comparison of lower abdominal pain score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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