Clinical trial

Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery: A Randomized Controlled Trial

Name

2019-1282

Description

Enhanced recovery pathways (ERPs) emphasize evidence-based, multimodal anesthetic and analgesic choices to minimize opioid consumption while providing adequate pain control after surgery. Although ERPs for spine surgery are now being described, few pathways include regional analgesia. The Erector Spinae Plane Block (ESPB) may represent a novel opportunity to incorporate regional analgesia into ERPs for spine surgery. To date, there is minimal data to support the utility of ESPB in spine surgery, and this block has not yet been evaluated in complex spine surgery. This study seeks to see whether ESPB will reduce opioid consumption and pain scores, and improve patient recovery during the first 24 hours after complex spine surgery when included in a comprehensive ERP.

Trial arms

Trial start

2019-11-19

Estimated PCD

2022-06-18

Trial end

2022-06-18

Status

Completed

Phase

Early phase I

Treatment

Bupivacaine

Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.

Arms:

ESPB with Bupivacaine and Dexamethasone

Other names:

Marcaine

Dexamethasone

Dexamethasone is a corticosteroid that reduces inflammation.

Arms:

ESPB with Bupivacaine and Dexamethasone

Other names:

Decadron

Saline

Saline is a mixture of NaCl and water that can be used as a placebo.

Arms:

ESPB with saline placebo

Other names:

sodium chloride

Size

Primary endpoint

Intraoperative and Postoperative Opioid Consumption

0-24 hours after surgery (intraoperative + immediately after surgery)

Eligibility criteria

Inclusion Criteria: * Age 18-80 * Planned primary complex spine surgery: \>2 level- lumbar and/or thoraco-lumbar spine fusion with or without decompression * Planned stand-alone posterior surgical approach * Able to follow study protocol * Able to communicate in English (outcome questionnaires validated in English) Exclusion Criteria: * Age \<18 or \>80 * Revision surgery * BMI \> 35 * planned prolonged intubation/intubation overnight on night of surgery * Unable to communicate in English * History of chronic pain condition requiring gabapentin/pregabalin/antidepressant medication longer than 3 months * Opioid tolerance (\>60 OME daily for \>2 weeks) * Allergy, intolerance or contraindication to any protocol component/study medication/technique * Patient refusal of regional analgesia (ESPB)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}

Updated at

2024-05-24

1 organization

2 products

3 indications

Organization

Hospital for Special Surgery

Product

Indication

Indication

Indication

Product