Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Preincisional Local Field Block for Perioperative Analgesia in Lumbar Spine Surgeries; Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- duration of postoperative analgesia
Study Overview
Brief Summary
Major lumbar spine surgeries are associated with significant postoperative pain that may last for days,So In this study, we intend to evaluate if preventive analgesia with a single injection dose of ultrasound guided bilateral erector spinae is a safe and better method of peri-operative analgesia for lumbar spine surgeries than preincisional local field block.
Detailed Description
Patients scheduled for lumbar spine surgery will be recruited and a written informed consent will be obtained from patients.
All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications. Laboratory work needed will be: Complete blood count (CBC); prothrombin time and concentration (PT& PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT) , liver function tests and kidney function tests .
● Operating Room preparation & Equipment: The ultrasound used will be curvilinear high-frequency ultrasound transducer (Siemens acuson x300 3-5 MHz ultrasound)
• Methods: General anaesthesia will be induced. 1.5 μg/kg fentanyl based on lean body weight with maximum dose of 200 μg and 2 mg/kg propofol will be given based on total body weight. Tracheal intubation will be facilitated with 0.5 mg/kg atracurium based on ideal body weight.
Volume controlled ventilation will be adjusted to maintain normocapnia . Anesthesia will be maintained by using 1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 18-65 years old.
- •Patients undergoing Lumbar spine surgery (L1-L5).
- •American society of anesthesiologists classification (ASA) I and II.
- •BMI < 35
- •Duration of surgery less than 3 hours
Exclusion Criteria
- •Patient's refusal.
- •Bleeding disorders (platelets count < 150,000; INR >1.5; PC< 60%) and coagulopathies.
- •Skin lesion, wounds or infection at the injection site.
- •Known allergy to local anesthetic drugs.
- •Chronic opioid users.
- •Patients with pre-operative opioid consumption.
- •Patients on long term therapy of Corticosteroids
Outcomes
Primary Outcomes
duration of postoperative analgesia
Time Frame: 24 hours
Time to first analgesic request
Secondary Outcomes
- patient satisfaction with anesthesia(24 hours)
- surgeon satisfaction for surgical field accessibility(2 hours)
- cumulative 24 hour opioid consumption(24 hours)
- pain assessment using VAS score at 15minutes, 30 minutes,1,2,4,8,12,24 hours postoperative(24 hours)
- presence of any complications(evey 10 minutes intraoperative till end of surgery (up to 2 hours))
Investigators
Abd elmoneim Adel Abd elmoneim
clinical professor
Cairo University