Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery

Summary

Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use, despite use of multimodal analgesia. The erector spinae plane block (ESPB) is a promising locoregional anesthetic technique for this type of surgery. The literature is not yet conclusive about the effectiveness of this technique on reducing postoperative pain intensity.

Objective: The objective of this study is to evaluate the analgesic effect of ESPB as add-on therapy to multimodal analgesia on early postoperative pain intensity after lumbar spinal fusion surgery compared to placebo.

Study design: The study is designed as a prospective mono-centre, randomized, double-blinded, placebo-controlled trial.

Study population: 76 patients ≥ 18 years of age requiring elective lumbar spinal fusion surgery involving one to four fusion levels.

Intervention: Patients will receive ultrasound-guided ESPB with either ropivacaine or placebo at the end of surgery.

Main study parameters/endpoints: Main study parameter is pain intensity upon emergence from anesthesia measured with the Numeric Rating Scale. A minimal clinically important difference is considered to be a decrease of 1.5 points. Secondary endpoints are pain intensity during hospital stay and after 30 days, opioid use during hospital stay and after 30 days, opioid side effects, use of anti-emetics, time to first opioid use/request, length of hospital stay, quality of recovery at discharge.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Sint Maartenskliniek is experienced in applying locoregional analgesia, the use of ropivacaine and using sonography. The procedure of administering ESPB has a very low risk of complications. Receiving placebo is justifiable because this group will not be withhold standard treatment. The risks of receiving placebo are negligible. The patients will visit the clinic at regular follow-up moments.

Conditions

• Spondylolisthesis
• Lumbar Disc Herniation
• Lumbar Spinal Stenosis
• Lumbar Disc Disease
• Lumbar Spondylolisthesis
• Lumbar Spondylosis
• Lumbar Spine Disease
• Lumbar Radiculitis
• Spinal Fusion
• Fusion of Spine
• Spondylosis Lumbosacral Region

Interventions

DRUG

Ropivacaine Hydrochloride Injection

Investigating the effectiveness of erector spinae plane block with ropivacaine for lumbar spinal fusion surgery versus placebo.

DRUG

Sodium chloride

Placebo comparator

Sponsors & Collaborators

• Radboud University Medical Center

  collaborator OTHER

• Ilse van de Wijgert

  lead OTHER

Principal Investigators

• M.G.E. Fenten, MSc, PhD, MD · Sint Maartenskliniek

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2023-12-19

Completion

2024-01-19

Countries

• Netherlands

Study Locations