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Investigating the effect of epidural analgesia with general anesthesia on pain intensity and common complications after laparoscopic cholecystectomy compared to general anesthesia

A comparative study of the effect of general anesthesia , general anesthesia/ epidural analgesia on pain intensity and common complications after laparoscopic cholecystectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200207046408N3
Enrollment
100
Registered
2024-02-20
Start date
2024-04-03
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain intensity after laparoscopic cholecystectomy. Calculus of gallbladder with chronic cholecystitis without obstruction

Interventions

Intervention 1: Intervention group: The intervention group patients will receive a single shot of epidural anesthesia with 0.06 mg/kg marcaine 0.05% and 0.14 ml/kg lidocaine 2% as an injection before

Sponsors

Yasouj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Roostapour

Yasouj University of Medical Sciences

dr.aliroostapour@gmail.com+98 74 3333 7001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026