Randomized Control Trial of Quadratus Lumborum Block for Lumbar Spine Decompression and Fusion Surgery

NCT04447950 | Unknown

• 1 other identifier: 0012-20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar spinal decompression and fusion is a commonly performed procedure fro neural impingement and back pain from a variety of pathologies. The importance of pain control in the postoperative period for spinal surgery has been discussed and proven extensively, with both immediate and delayed reduction in complications and improved clinical results. Quadratus lumborum (QL) block was introduced in 2007 and is performed under ultrasound guidance for perioperative pain management in various surgeries.However, the plane for a posterior QL block can be easily reached during open midline spinal surgery. The investigators hypothesize that the posterior QL block is an effective analgesic tool for lumbar laminectomy surgery, because in lumbar laminectomy the quadratus lumborum is already exposed and is in direct visual contact. For that reason it is imperative to test the benefits of this procedure. This is a double blinded randomized control study to assess the results of intra-operative QL block performed for lumbar decompression and fusion.

Conditions

Spinal Stenosis Lumbar; Spondylolisthesis; Fusion of Spine, Lumbar Region; Degeneration Spine

Outcome Measures

Primary Outcomes (1)

• Change in the use of post-operative narcotics

  Difference in MME (morphine milligrams equivalent) of inpatient narcotics consumption.

  Will be reported for each postoperative day during the inpatient stay of the patient to a maximum of 7 days.

Study Arms (2)

Study group

EXPERIMENTAL

Posterior QL block with 20-40 cc of Bupivocaine in posterior border of Quadratum Lumborum muscle at the end of the operation.

Procedure: Type 2/posterior Quadratus Lumborum block

Placebo group

PLACEBO COMPARATOR

Posterior QL block with 40 cc of Saline in posterior border of Quadratum Lumborum muscle at the end of the operation.

Procedure: Placebo block with Saline

Interventions

Type 2/posterior Quadratus Lumborum block PROCEDURE

Injection of local anaesthetic into posterior boundry of Quadratus Lumborum muscle.

Study group

Placebo block with Saline PROCEDURE

Injection of saline into posterior boundary of Quadratus Lumborum muscle.

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women at the ages of 18-80 suffering from leg + back pain or neurological claudication.
• Undergoing an elective 1-3 level lumbar laminectomy \& fusion at Assuta medical center.

You may not qualify if:

• Chronic narcotic treatment (more than 3 months)
• Current active Infection.
• Underwent any other major operation in the last two months.
• Known hypersensitivity to local anaesthetic
• Previous lumbar instrumentation (revision of decompression to decompression with fusion will be included)
• Non Ambulatory patients

Sponsors & Collaborators

• Assuta Medical Center: lead

Study Sites (1)

The Israeli spine center, Assuta medical center

Tel Aviv, 69710, Israel

Location

Related Publications (7)

• Benz RJ, Garfin SR. Current techniques of decompression of the lumbar spine. Clin Orthop Relat Res. 2001 Mar;(384):75-81. doi: 10.1097/00003086-200103000-00010.

  PMID: 11249182 BACKGROUND

• Elsharkawy H. Quadratus Lumborum Blocks. Adv Anesth. 2017;35(1):145-157. doi: 10.1016/j.aan.2017.07.007. Epub 2017 Oct 3. No abstract available.

  PMID: 29103570 BACKGROUND

• Iwamitsu R, Ueshima H, Otake H. RETRACTED: Intermittent bilateral posterior quadratus lumborum block was effective for pain management in lumbar spinal fusion. J Clin Anesth. 2017 Nov;42:16. doi: 10.1016/j.jclinane.2017.08.012. Epub 2017 Aug 6. No abstract available.

  PMID: 28793274 BACKGROUND

• Ueshima H, Otake H. RETRACTED: Clinical experience of anterior quadratus lumborum block after lumber surgery. J Clin Anesth. 2017 Feb;37:131. doi: 10.1016/j.jclinane.2016.12.014. Epub 2017 Jan 9. No abstract available.

  PMID: 28235503 BACKGROUND

• Yoo JS, Ahn J, Buvanendran A, Singh K. Multimodal analgesia in pain management after spine surgery. J Spine Surg. 2019 Sep;5(Suppl 2):S154-S159. doi: 10.21037/jss.2019.05.04.

  PMID: 31656869 BACKGROUND

• Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S. Causes and risk factors for 30-day unplanned readmissions after lumbar spine surgery. Spine (Phila Pa 1976). 2014 Apr 20;39(9):761-8. doi: 10.1097/BRS.0000000000000270.

  PMID: 24525993 BACKGROUND

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

  PMID: 17179269 BACKGROUND

MeSH Terms

Conditions

Spondylolisthesis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ely Ashkenazy, MD

  Neurosurgeon, Assuta medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ely Ashkenazy, MD

CONTACT

+972-3-7645400; ashkenazy@isc.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Rotating nurse assigning the arm, scrubbed nurse preparing syringe for injection with a clear liquid - saline vs saline and Marcaine, surgeon blinded to type of liquid in syringe.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ely Ashkenazy, neurosurgeon

Model Details: 2 arms of a RCT.

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 25, 2020
• Study Start: June 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)