Investigating the effect of epidural analgesia with general anesthesia on pain intensity and common complications after laparoscopic cholecystectomy compared to general anesthesia
Phase 3
- Conditions
- Pain intensity after laparoscopic cholecystectomy.Calculus of gallbladder with chronic cholecystitis without obstructionK80.10
- Registration Number
- IRCT20200207046408N3
- Lead Sponsor
- Yasouj University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
A patient who is a candidate for laparoscopic cholecystectomy surgery (with symptomatic gallstones without complications, with ASA grade 1 or 2)
Willingness to participate in the study
Age between 18 and 70 years
The patient should have mental health
Exclusion Criteria
Presence of concomitant systemic disease
History of allergy to general anesthetics and epidural anesthesia
Previous history of abdominal surgery
Acute cholecystitis and acute pancreatitis
Main bile duct stone cholangitis
Having or suspecting gallbladder malignancy
Having or suspecting heart failure and severe COPD
Suffering or history of migraine
pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain intensity :Numerical rating scale of pain intensity, which is measured by asking the patient to choose a number (between 0 and 10) and based on the McGill pain intensity scale. Timepoint: Pain intensity as the main outcome in all patients in two study groups is evaluated by McGill questionnaire at the time of admission and before surgery. Then the same evaluation is done in the recovery room after the operation (zero hour) and 4, 6, 12, 24 hours after the end of the surgery. Method of measurement: McGill Pain Intensity Scale Questionnaire.
- Secondary Outcome Measures
Name Time Method Common complications after laparoscopic cholecystectomy :Hypotension, bradycardia, hypoxemia, headache, nausea, vomiting, right shoulder pain, abdominal discomfort related to anesthesia and pneumoperitoneum, urinary retention. Timepoint: Evaluation is done in the recovery room after the operation (zero hour) and 4, 6, 12, 24 hours after the end of the surgery. Method of measurement: 1. Hypotension (more than 30% decrease in baseline mean arterial pressure or systolic arterial pressure less than 90 mm Hg) 2. Bradycardia (heart rate less than 50 beats per minute) 3. Hypoxemia (SpO2 less than 90) 4. Headache or not 5. Nausea and vomiting or not 6. Right shoulder pain or not 7. Abdominal discomfort or not 8. Urinary retention or not.