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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05428982
• Other study ID #: 65055
• Status: Completed
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: July 2023
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease
• Pain, Postoperative
• Post Operative Pain
• Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Total amount of antiemetic drugs in 24 hours postoperatively	Total amount of antiemetic drugs in 24 hours postoperatively	24 hours postoperatively
Secondary	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
Secondary	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