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Clinical Trials/CTRI/2025/10/096229
CTRI/2025/10/096229Not yet recruitingPhase 3

Comparison of segmental thoracic spinal anaesthesia and general anaesthesia in umbilical and supraumbilical hernia surgeries

Peoples Hospital Bhopal1 site in 1 country70 target enrollmentStarted: November 1, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
To Observe Hemodynamic Parameters And Post-Operative Recovery In Patients Undergoing Segmental Thoracic Spinal Anaesthesia And General Anaesthesia and To Compare Between The Observations Of The Two Groups

Study Overview

Brief Summary

Patients will be divided into 2 groups, Group S receiving Segmental Thoracic Spinal Anaesthesia and Group G receiving General Anaesthesia.

In Group S, the patients posted for elective umbilical and supraumbilical hernia surgeries, STSA will be given by a 25G Quincke’s Needle at T10 level with Injection 0.5% Isobaric Levobupicavaine 6.25 mg (1.25ml) with Injection Fentanyl 25 mcg administered at a speed of 0.2 ml/second. Sensory effect will be measured by pin prick method.

In Group G, the patients posted for both elective umbilical and supraumbilical hernia surgeries, after pre oxygenation with 100% oxygen for 3 minutes, injection Glycopyrrolate 2-4 mcg/kg, Injection Ondansetron 0.2 mg/kg, Injection Midazolam 0.1-0.2 mg/kg, Injection Fentanyl 1-2 mcg/kg, patients will be induced with Injection Propofol 2 mg/kg and Injection Atracurium 0.5-0.6 mg/kg. Anaesthesia will be maintained with Oxygen, Nitrous Oxide, Isoflurane and injection Atracurium 0.1mg/kg and Paracetamol 1 gm intravenously as required. After the completion of the said surgery, patients will be reversed with Injection Glycopyrrolate 0.01 mg/kg and Injection Neostigmine 0.05 mg/kg and extubated.

The hemodynamic parameters will be noted down at the time of injection (0 minutes), at 2 minutes, at 5 minutes, 10 minutes, 15 minutes, 30 minutes and 1 hour, 2 hour, 4 hour, 6 hour. VAS Scoring will be done postoperatively at 1 hour, 2 hour,4 hours, and 6 hours respectively. Time required opr rescue analgesia will be noted in both the groups. Perioperative complication will be noted and managed if any.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA Grade I & II Patients Scheduled For Elective Umbilical And Supraumbilical Hernia Surgeries.

Exclusion Criteria

  • Patient Refusal Age Less Than 18 Years And More Than 65 Years ASA Grade III Or More BMI More Than 35 Kg Per m2 Patients With Uncorrected Hypovolemia Or Shock Patients With Raised Intracranial Pressure Patients With Abnormal Coagulation Profile Patients With Hypersensitivity To Any Of The Drugs Used Pregnant And Lactating Mother.

Outcomes

Primary Outcomes

To Observe Hemodynamic Parameters And Post-Operative Recovery In Patients Undergoing Segmental Thoracic Spinal Anaesthesia And General Anaesthesia and To Compare Between The Observations Of The Two Groups

Time Frame: Upto 6 hours

Secondary Outcomes

  • To compare the time needed for rescue analgesia in the two groups(Upto 6 hours)

Investigators

Sponsor
Peoples Hospital Bhopal
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Rajvardhan Singh

Peoples College of Medical Sciences and Research Centre Bhopal

Study Sites (1)

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