Comparing the effect and outcomes between General Anesthesia Vs Combined Epidural and General Anesthesia in Elective Lumbar Spine Surgery: A Randomized Control Study.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- To assess and show the efficacy of Combined Epidural with General Anesthesia over sole General Anesthesia in variables such as Mean arterial pressure, Heart Rate, blood loss and amount of anesthetic agents used.
Study Overview
Brief Summary
AIM OF THE STUDY:
To compare the effect and outcomes both intraoperatively and postoperatively following the sole general anesthesia and combined epidural/general anesthesia in Lumbar spine disc surgeries.
PRIMARY OBJECTIVE: To assess and show the efficacy of combined epidural and general anesthesia over sole general anesthesia in variables such as Mean arterial blood pressure, Heart rate, Blood loss and amount of anesthetic agents used.
METHODOLOGY:
- Patients who are undergoing lumbar spine surgeries will be randomly grouped under Group ’A’ and Group ’B’. Group A being patients receiving General anesthesia and Group B being patients receiving a combined Epidural and General anesthesia.
- Group B patients will initially be given epidural single injection of 18ml of 0.25% Bupivacaine (45mg) + 25mcg of Fentanyl (2 ml) in 18 ml of distilled water administered either at the same or a level below the level of surgery in the sitting position, using Epidural Tuohy 18G under strict aseptic precautions. Following epidural Group B patients will be administered General anesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA Grade 1 and
- •In patients diagnosed with lumbar spine disease involving one or two levels.
Exclusion Criteria
- •patients refusal for consent for epidural.
- •patients with systemic anticoagulation ailments.
- •patients with septicemia.
- •patients with local infection at the site of epidural.
Outcomes
Primary Outcomes
To assess and show the efficacy of Combined Epidural with General Anesthesia over sole General Anesthesia in variables such as Mean arterial pressure, Heart Rate, blood loss and amount of anesthetic agents used.
Time Frame: Intraoperative monitoring of hemodynamic variables for every 15 minutes till the end of surgery.
Secondary Outcomes
- Postoperative pain assessment & duration at which analgesic rescues were given.(Pain assessment at 2hours, 4 hours, 6 hours, 12 hours & 24 hours postoperatively.)
Investigators
Dr Priyadharshini V
SHRI B M PATIL MEDICAL COLLEGE, HOSPITAL & RESEARCH CENTRE, VIJAYAPURA.