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Clinical trial comparing the effectiveness of intraperitoneal bupivacaine, acetazolamide and placebo on pain relief after laparoscopic cholecystectomy surgery

Clinical trial comparing the effectiveness of intraperitoneal bupivacaine, acetazolamide and placebo on pain relief after laparoscopic cholecystectomy surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017032733159N1
Enrollment
60
Registered
2017-06-06
Start date
2017-05-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Calculus of gallbladder without cholecystitis. Cholecystolithiasis Cholelithiasis Colic (recurrent) of gallbladder Gallstone (impacted) of: cystic duct gallbladder unspecified or without cholecystitis

Interventions

Intervention 1: intraperitoneal and local bupivacaine 0.5%. The maximum dose was 2 mg per kilogram. At the end of surgery and just one time. Intervention 2: 0.5 mg per kg intravenous acetazola
Prevention
intraperitoneal and local bupivacaine 0.5%. The maximum dose was 2 mg per kilogram. At the end of surgery and just one time
0.5 mg per kg intravenous acetazolamide Once at the end of the surgery
2 cc intravenous saline as placebo Once at the end of the surgery

Sponsors

Vice Chancellor for research of Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: having physical status I or II of the ASA system (American Society of Anesthesiologists); aged 20 to 60 years; who were candidate for laparoscopic cholecystectomy surgery due to gallstone. Exclusion criteria: Patients who do not consent to be included in the study; bile duct problems; acute cholecystitis; lack of ability to understand and use visual analogue scale (VAS); experience of sensitivity to NSAIDs and local anesthetics; class III and IV of ASA system; patients with choledocolitiasis; and drain in situ.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: just after surgery then 1, 4, 8, 12, and 24 hour after that. Method of measurement: visual analog scale.;Paracetamol usage. Timepoint: just after surgery then 1, 4, 8, 12, and 24 hour after that. Method of measurement: according to patient documents.

Secondary

MeasureTime frame
Heart rate. Timepoint: just after surgery then 1, 4, 8, 12, and 24 hour after that. Method of measurement: documentd by doctor.;Systolic blood pressure. Timepoint: just after surgery then 1, 4, 8, 12, and 24 hour after that. Method of measurement: documentd by doctor.;Diastolic blood pressure. Timepoint: just after surgery then 1, 4, 8, 12, and 24 hour after that. Method of measurement: documentd by doctor.;Respiratory rate. Timepoint: just after surgery then 1, 4, 8, 12, and 24 hour after that. Method of measurement: documentd by doctor.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Alireza Negahi

Surgery ward, Rasool Akram hospital

arnegahi@gmail.comh.vaseghi@yahoo.com+216 4352215

Outcome results

None listed

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