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

Conditions: 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

Registration Number: CTRI/2015/04/005715

Lead Sponsor: Dr Ram Bhakta Koju

Brief Summary: **Background:** Cholecystectomy is performed either as openor laparascopic cholecystectomy. Despite of a number of peri-operative andpost-operative benefits of laparascopic cholecystectomy, the older and moreinvasive open cholecystectomy is still in frequent practice for variousreasons. Though general anaesthesia is regarded as the gold standard anaesthetictechnique, alternatives to it such as spinal anaesthesia, with its advantages,outweighs general anaesthesia. Spinal anaesthesia, therefore, could be a safe and effective anaesthetic procedure overgeneral anaesthesia for open cholecystectomy.

**Methods:** After the approval from the hospital ethicalcommittee and written consent received from the patients, 120 patients withuncomplicated symptomatic gallstone disease undergoing open cholecystectomy andcomplying with ASA I or II physical status, aged between 18 and 70 years of eithersex, and BMI â‰¤ 30 kg/m2 were enrolled for thestudy. They were randomly categorized into SA group (received spinal anaesthesia)and GA group (received general anaesthesia), each group containing 60 patients.Intra-operative events and post-operative events were observed up to 48 hourspost-surgery and compared between the groups. Data are represented inpercentage, mean with standard deviation and median. Statistical analysis wasdone using independent t-test and Mann-Whiteney U test.

**Results:** Spinal anaesthesia is safe and effective in pain management post opencholecystectomy. The pain-free interval in SA group was 4 hours as compared to 30 minutes in GA group. Majority (90%) in SA groups were managed withintramuscular diclofenac whereas majority in GA group were managed withintravenous pethedine. Intra-operatively, SA group had more cases of haemodynamicinstability than GA group, which were easily managed in both the groups. The differencesin the incidence of post-operative nausea and vomiting and the days of hospitalstay between the groups were not significant.

**Conclusion:** Spinal anaesthesia is safe and more effective than general anaesthesiafor uncomplicated open cholecystectomy in terms of peri-operative events, inreducing post-operative pain, and in terms of surgeonâ€™s satisfaction as well.

**Keywords:** Cholelithiasis,General anaesthesia, Open cholecystectomy, Pain, Spinal anaesthesia

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Applicable

Sex: All

Target Recruitment: 120

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 â‰¤ 30 kg/m2.

Exclusion Criteria

Pancreatitis, contraindication of SA, hypersensitivity to bupivacaine and pethedine and severe cardiopulmonary disease for both SA and GA group.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Pain-free interval post-surgery	1, 2, 4, 8, 12, 16, 24 and 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
1) Hemodynamic instability	2) Post operative nausea and vomiting

Trial Locations

Locations (1): Korea Nepal Friendship Hospital
🇮🇳
Bhaktapur,, India
Korea Nepal Friendship Hospital
🇮🇳Bhaktapur,, India
Dr Ram Bhakta koju
Principal investigator
977-9841113271
dr.koju@gmail.com