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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Post Operative Pain, Shoulder Pain, Gynecologic Disease

Intervention / Treatment
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* Procedure: Postoperative Modified Trendelenburg position


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Modified Trendelenburg, Shoulder Pain, Laparoscopic hysterectomy