Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery

NCT05345249 | Completed Phase 4

• 3 other identifiers: 09842021-003679-32NL9640
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Erector spinae block; Lumbar interbody fusion; Regional anesthesia; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity one hour after arrival at post-anesthesia care unit

  Numeric Rating Scale (NRS) for pain 0-10 (0 = no pain, 10 = maximum pain) as asked by PACU-nurse

  1 hour after arrival at PACU

Secondary Outcomes (10)

• Acceptability of pain

  1 hour after arrival at PACU

• Opioid use

  0-12 hours, 12-24 hours after surgery

• Presence of opioid side effects

  12 hours, 24 hours after surgery

• Time to first opioid use/request

  12 hours after surgery

• Time to first mobilization

  72 hours after surgery

Other Outcomes (1)

• Drain wound leakage

  Postoperative day 1, 2 and 3

Study Arms (2)

ESPB with ropivacaine

EXPERIMENTAL

Patients in the experimental group will receive locoregional analgesia via ESPB with injectate consisting of ropivacaine 0.375 mg/mL with no additives, two times 30mL bilaterally at the transverse processs of the T12-vertebra (total dose of 225 mg).

Drug: Ropivacaine Hydrochloride Injection

ESPB with placebo

PLACEBO COMPARATOR

Patients in the placebo group will receive an injection performed as the procedure of ESPB with injectate consisting of sodiumchloride 0.9% with no additives, two times 30mL bilaterally at the transverse processs of the T12-vertebra.

Drug: Sodium chloride

Interventions

Ropivacaine Hydrochloride Injection DRUG

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

Also known as: SMPC h104944, Ropivacaine HCl

ESPB with ropivacaine

Sodium chloride DRUG

Placebo comparator

Also known as: SMPC h55227, NaCl 0.9%

ESPB with placebo

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years;
• Patients planned for elective lumbar spinal fusion surgery with a dorsal surgical approach;
• fusion level spine surgery;
• Written informed consent.

You may not qualify if:

• A Body Mass Index (BMI) \> 40 kg/m²;
• ASA physical health classification \> 3;
• Patients who will undergo spine surgery involving less than 2 or more than 4 levels of fusion, scoliosis surgery\*;
• Patients who will undergo circumferent spine surgery;
• Patients with an active, local infection or systemic infection;
• Patients with an allergy to one or more medications used in the study;
• Patients with any contraindication to a regional anesthetic technique;
• Kidney- or liver failure inhibiting the systemic use of paracetamol and/or NSAIDs;
• Acute surgeries;
• Patients with a history of drugs or alcohol abuse;
• Pregnancy;
• Cognitive impairment;
• Inability to speak or understand the Dutch language.

Sponsors & Collaborators

• Ilse van de Wijgert: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Sint Maartenskliniek

Ubbergen, Gelderland, 6500GM, Netherlands

Location

Related Publications (7)

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 BACKGROUND

• Alboog A, Bae S, Chui J. Anesthetic management of complex spine surgery in adult patients: a review based on outcome evidence. Curr Opin Anaesthesiol. 2019 Oct;32(5):600-608. doi: 10.1097/ACO.0000000000000765.

  PMID: 31461735 BACKGROUND

• Huang W, Wang W, Xie W, Chen Z, Liu Y. Erector spinae plane block for postoperative analgesia in breast and thoracic surgery: A systematic review and meta-analysis. J Clin Anesth. 2020 Nov;66:109900. doi: 10.1016/j.jclinane.2020.109900. Epub 2020 Jun 2.

  PMID: 32502778 BACKGROUND

• Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.

  PMID: 32669870 BACKGROUND

• Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.

  PMID: 30853517 BACKGROUND

• Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.

  PMID: 31033625 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

MeSH Terms

Conditions

Spondylolisthesis; Intervertebral Disc Displacement; Spinal Stenosis; Intervertebral disc disease; Spondylosis; Spinal Diseases; Radiculopathy; Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Spondylolysis; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• M.G.E. Fenten, MSc, PhD, MD

  Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After obtaining informed consent, the coordinating researcher creates a study case. Patients will be randomly allocated in a 1:1 ratio to either the study group (ESPB) or the control group (placebo) by the hospital's pharmacist on the day of surgery. Permuted block randomization with varying permuted block sizes will be used. This block randomization list will be created by Sealed EnvelopeTM and managed by the hospital's pharmacist. Only the hospital's pharmacist will have access to the randomization list. The staff involved (doctors, nurses, operation room personal), as well as the research team and the patient will be blinded for treatment allocation. The hospital's pharmacist prepares the medication on the morning of surgery, delivers it at the operation complex and collects empty syringes after injection in terms of drug accountability.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients scheduled for elective lumbar spinal fusion surgery will be studied. Subject of investigation is the locoregional anesthetic technique ESPB. Subjects will be randomized to receive either ESPB with a long-acting local anesthetic or normal saline (placebo). The staff involved (doctors, nurses, OR-personal), as well as the research team and the patient will be blinded for treatment allocation. The study period includes in-hospital time after surgery and follow-up 30 days after surgery. Placement of the ESPB will be performed according to the study protocol, at the end of surgery, after wound closure. The placement of the ESPB is performed according to daily clinical practice as described by Forero et al. Postoperative treatment of patients will be according to standard hospital protocol for lumbar spinal fusion surgery.

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 25, 2022
• Study Start: June 1, 2022
• Primary Completion: December 19, 2023
• Study Completion: January 19, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After end of inclusion period for at least 5 years.
• Access Criteria: DANS EASY will be data repository for open access. FAIR Guiding Principles are followed to make data Findable, Accessible, Interoperable and Reusable. An Open Access-licence is required to consult the data.

Locations

NL (1)