Ultrasound-Guided Lumbal Erector Spinae Plane Block on Postoperative Pain Management After Total Hip Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- morphine consumption
Study Overview
Brief Summary
The Erector Spinae Plane (ESP) block or spinal erector block was first described in September 2016 by a Canadian team. It's a block that was initially used for the treatment of chronic thoracic neuropathic pain. The ESP block is one of the inter-fascicular blocks and it's an easy-to-perform technique.In the literature, it has been reported that Lumbar ESPB provides effective analgesia after a hip surgery.
The purpose of this prospective randomized study was to compare the analgesic effects of the ultrasound-guided lumbar Erector Spinae Plane block on postoperative pain management versus the multimodal analgesia after total hip arthroplasty.
Detailed Description
Patients aged more than 18 years, ASA I-III scheduled for primary total hip arthroplasty with lateral approach and under general anesthesia Patients were randomly assigned, into 1 of 2 groups, namely, group ESPBL and group Placebo, using sealed envelopes
- For ESPBL group: Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block.
- For Placebo group: patients had multimodal analgesia without lumbar ESP block Patients will be transferred to continuous care unit for 24 hours.
Post-operative analgesia will include:
- Paracetamol 1g IV every 8 hours for 1 day then oral paracetamol 1g every 8 hours for 4 weeks.
- Diclofenac sodium(50mg) 1 tablet x 2 per day for 5 days.
- PCA morphine (Patient Controlled Analgesia), as a rescue analgesia, programmed as: Bolus of 1mg/ refractory period of 10 min/ maximum dose set up at 10mg every 12h.
The primary outcome of the study is to compare postoperative opioids consumption in the first 24 postoperative hours.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •primary total hip arthroplasty with lateral approach and under general anesthesia .
Exclusion Criteria
- •• Contraindication or refusal to regional anesthesia
- •Contraindication to non-steroidal anti-inflammatory (NSAID's)
- •Allergy to opioids
- •Allergy to paracetamol
- •Creatinine clearance < 30ml/min
- •Weight<50 kg or >100kg
- •Psychiatric disorders and difficulty of communication
- •Lower limb neurological deficit
- •Patients undergoing bilateral or revision total hip replacement
Arms & Interventions
hip arthroplasty with nerve block
Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block
Intervention: Lumbal Erector Spinae Plane Block (Procedure)
hip arthroplasty with intravenous pain killers
intravenous pain killers
Intervention: intravenous pain killers (Procedure)
Outcomes
Primary Outcomes
morphine consumption
Time Frame: Day 1
total morphine dose
Secondary Outcomes
- pain scores(Hour 2, Hour 4, Hour 6, Hour 12, Hour 18, Hour 24 and on Day 2 and Day 7.)
- intraoperative opioid consumption(end of surgery)
- pain on sitting position(Day 1)
- QR 9 score(Day 2)
- ROM(Day 1)
- pain during walk(Day 7)
Investigators
Olfa kaabachi, MD
professor
University Tunis El Manar