Is spinal anaesthesia more safe and effective than general anaesthesia for open surgery of gall bladder?

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/04/005715
• Date of registration: 24-04-2015
• Prospective Registration: No
• Primary sponsor: Dr Ram Bhakta Koju
• Public title: Is spinal anaesthesia more safe and effective than general anaesthesia for open surgery of gall bladder?
• Scientific title: A comparative study on safety and effectiveness of spinal anaesthesia versus general anaesthesia for open cholecystectomy.
• Date of first enrolment: 01-08-2010
• Target sample size: 120
• Recruitment status: Not Applicable
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11371
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Case Record Numbers Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: N/A

Countries of recruitment

Nepal

Contacts

• Name: Ram Bhakta Koju
• Affiliation: KIST Medical College

• Name: Ram Bhakta Koju
• Affiliation: KIST Medical College

Key inclusion & exclusion criteria

Inclusion criteria: Patients with uncomplicated symptomatic gallstone disease undergoing open cholecystectomy and complying with ASA I or II physical status, aged between 18 and 70 years of either sex, and BMI <= 30 kg/m2.
Exclusion criteria: Pancreatitis, contraindication of SA, hypersensitivity to bupivacaine and pethedine and severe cardiopulmonary disease for both SA and GA group.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Uncomplicated symptomatic gallstone disease with ASA I or II physical status, aged between 18 and 70 years of either sex, and BMI â?¤ 30 kg/m2

Intervention(s)

Intervention1: Spinal anesthesia: Spinal anesthesia is used as an anesthetic technique.
Control Intervention1: General anesthesia: General anesthesia is used as an anesthetic technique

Primary Outcome(s)

1) Pain-free interval post-surgeryTimepoint: 1, 2, 4, 8, 12, 16, 24 and 48 hours after surgery

Secondary Outcome(s)

1) Hemodynamic instability

2) Post operative nausea and vomiting

3)Respiratory problems

4)Analgesic required to manage pain

5)Post-dural puncture headache

Timepoint: 1, 2, 4, 8, 12, 16, 24 and 48 hours after surgery

Secondary ID(s)

NIL

Source(s) of Monetary Support

Principal investigator self funded study with the infrastructure and other logistic support from the Korea Nepal Friendship Hospital

Ethics review

Status: Approved
Approval date: 15/07/2010
Contact:

Hospital Authority