Shoulder Pain Clinical Trial
Official title:
The Effect of Postoperative Modified Trendelenburg Position to Decrease Shoulder Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial
NCT number | NCT05428982 |
Other study ID # | 65055 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 30, 2022 |
Est. completion date | August 30, 2023 |
Verified date | July 2023 |
Source | Rajavithi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Rajavithi Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Rajavithi Hospital |
Thailand,
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 |
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