Lumbar Epidural Analgesia With Bilateral Erector Spinae Block for Pain Management in Lumbar Spine Surgery

NCT04320212 | Completed

• 1 other identifier: M D-82 -2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical procedures on the spine and spinal cord are common and are performed for a wide variety of diseases. They range from minimally invasive, single-level decompression to highly complex, multi-stage extensive reconstruction. Operative procedures for degenerative spine diseases and herniated discs are most common in those under 60 years of age. While those over 60 years of age most commonly undergo spine surgery for spinal stenosis Patients undergoing spine surgery experience severe pain in the postoperative period. Recent studies show that the incidence of acute postoperative pain following spine surgery vary from 30 to 64%. Postoperative pain may also increase morbidity and incidence of complications and prolong postoperative rehabilitation. In addition, it is a risk factor for development of chronic pain syndromes Postoperative pain is usually treated with oral or intravenous opioids in combination with non-steroidal anti-inflammatory drugs. However, they often results in insufficient pain control and side effects such as respiratory depression, nausea, and vomiting. Epidural anaesthesia and analgesia have been shown to be superior to intravenous analgesia. The former is better with respect to pain quality, incidence of side effects, pulmonary, cardiac, and gastrointestinal dysfunction. However, it may be associated with hemodynamic instability. Migration of the epidural catheter with unpredictable absorption of the local anaesthetics remains a challenge to the anaesthetists. The Erector Spinae block proved to be efficient in controlling post-operative pain. It is a simple interfascial plane block, published in 2016. It provides effective analgesia for 24 hours in patients undergoing lumbar spine surgery. Therefore, a prospective, randomized study was designed to compare the analgesic and side effects of the epidural analgesia with the Erector Spinae block in patients undergoing lumbar spine surgery. To our knowledge, this is the first clinical trial that compares the Erector Spinae block with the epidural analgesia in a variety of lumbar spine surgeries.

Conditions

Perioperative Pain

Outcome Measures

Primary Outcomes (1)

• time to first analgesic request

  minutes

  from the time of performance of the intervention till the first analgesic requirement during the 24 hours postoperative

Secondary Outcomes (5)

• The numeric rate scale (NRS)

  5 minutes after extubation,1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hour postoperative

• postoperative morphine consumption

  5 minutes after extubation till 24 hour postoperative

• postoperative diclofenac consumption

  5 minutes after extubation till 24 hour postoperative

• systolic blood pressure

  every 10 minutes from skin incision to skin closure and at 2, 4 hours post operatively.

• heart rate

  every 10 minutes from skin incision to skin closure and at 2, 4 hours post operatively.

Study Arms (2)

lumber epidural analgesia

ACTIVE COMPARATOR

: the patient will be placed in the lateral position, Lidocaine will be given using 5 ml syringe and a 18 G Tuohy needle will be introduced in the epidural space, using the ultrasound, under strict aseptic precautions. The ultrasound probe will be placed 90 degrees into transverse orientation and slided cephalad or caudad to obtain the transverse interspinous view (TI view) 2 levels above the operation level. patient will receive 20 ml of 0.25% plain bupivacaine after negative aspiration for blood or cerebrospinal fluid. Then, the patient will be placed in prone position to start the surgical procedure

Procedure: lumber epidural analgesia

erector spinae analgesia

ACTIVE COMPARATOR

the patient will be placed in the prone position. Then, the Erector Spinae block will be given by a high-frequency linear ultrasound transducer. The Erector Spinae muscle and transverse process will be then identified, and a 18 G Tuohy needle will be advanced, using the in-plane approach, in cephalad-to-caudal direction, through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle. The block will be performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side)

Procedure: erector spinae analgesia

Interventions

lumber epidural analgesia PROCEDURE

the lumber epidural analgesia will be given after induction of general anesthesia.

lumber epidural analgesia

erector spinae analgesia PROCEDURE

the erector spinae analgesia will be given after induction of general anesthesia.

erector spinae analgesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I, II patients
• Aged 18-60 years
• Undergoing elective lumbar spine decompression and fusion surgery, using the posterior approach, under general anaesthesia.

You may not qualify if:

• Patients with severe cardiac diseases as ischemic heart disease, rheumatic valve disorders and cardiomyopathy.
• Contraindication to neuroaxial anaesthesia e.g. patients on anticoagulants, infection at the injection site and coagulopathy
• Hypersensitivity to the local anaesthetics used.
• Patient refusal.
• Neurologic deficits in the form of sensory loss, motor weakness or preexisting pain symptoms due to neurologic diseases apart from back pain associated with the planned operation.
• Patients with previous back surgeries

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Hospital

Cairo, Manial, 11562, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: March 24, 2020
• Study Start: April 1, 2020
• Primary Completion: March 20, 2021
• Study Completion: March 22, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

EG (1)