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

Primary Purpose

Post Operative Pain, Shoulder Pain, Gynecologic Disease

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Postoperative Modified Trendelenburg position

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Modified Trendelenburg, Shoulder Pain, Laparoscopic hysterectomy

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Postoperative Modified Trendelenburg group

Control

Arm Description

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

Patients underwent the laparoscopic hysterectomy were positioned in a neutral position

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Total amount of antiemetic drugs in 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

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

Full Information

NCT ID

NCT05428982

First Posted

June 7, 2022

Last Updated

July 3, 2023

Sponsor

Rajavithi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05428982

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

June 30, 2022 (Actual)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain, Shoulder Pain, Gynecologic Disease

Keywords

Modified Trendelenburg, Shoulder Pain, Laparoscopic hysterectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Postoperative Modified Trendelenburg group

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

Patients underwent the laparoscopic hysterectomy were positioned in a neutral position

Intervention Type

Procedure

Intervention Name(s)

Postoperative Modified Trendelenburg position

Intervention Description

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

Primary Outcome Measure Information:

Title

Comparison of shoulder pain score

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Comparison of nausea vomiting score

Description

Time Frame

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

Title

Total amount of antiemetic drugs in 24 hours postoperatively

Description

Total amount of antiemetic drugs in 24 hours postoperatively

Time Frame

24 hours postoperatively

Title

Comparison of upper abdominal pain score

Description

Time Frame

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

Title

Comparison of lower abdominal pain score

Description

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Rajavithi Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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