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

NCT ID: NCT05428982

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-08-30

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

Conditions

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Post Operative Pain Shoulder Pain Gynecologic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Postoperative Modified Trendelenburg group

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

Group Type EXPERIMENTAL

Postoperative Modified Trendelenburg position

Intervention Type PROCEDURE

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

Control

Patients underwent the laparoscopic hysterectomy were positioned in a neutral position

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Postoperative Modified Trendelenburg position

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rajavithi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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65055

Identifier Type: -

Identifier Source: org_study_id

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