Comparison of segmental thoracic spinal anaesthesia and general anaesthesia in umbilical and supraumbilical hernia surgeries
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
Rajvardhan Singh
Peoples College of Medical Sciences and Research Centre Bhopal
