Clinical trial NCT05428982: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Shoulder Pain
Gynecologic Disease
Keywords: Modified Trendelenburg, Shoulder Pain, Laparoscopic hysterectomy
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2022-06-23
Enrollment: 46
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Comparison of shoulder pain score
timeFrame: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Secondary outcomes:
measure: Comparison of nausea vomiting score
timeFrame: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
measure: Total amount of antiemetic drugs in 24 hours postoperatively
timeFrame: 24 hours postoperatively
measure: Comparison of upper abdominal pain score
timeFrame: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
measure: Comparison of lower abdominal pain score
timeFrame: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References: