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Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery (ESPB-Spine)

Primary Purpose

Opioid Use, Pain, Postoperative

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine

Dexamethasone

Saline

About this trial

This is an interventional treatment trial for Opioid Use

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ESPB with Bupivacaine and Dexamethasone

ESPB with saline placebo

Arm Description

23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight.

23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight.

Outcomes

Primary Outcome Measures

Total Opioid Consumption

Measured in mean oral morphine equivalents (OME)

Secondary Outcome Measures

Pain Scores at Rest

Measured by Numeric Rating Scale (NRS) pain at rest (0 being no pain and 10 being as bad as you can imagine)

Pain Scores with Physical Therapy

Measured by Numeric Rating Scale (NRS) pain with movement (0 being no pain and 10 being as bad as you can imagine)

Quality of Recovery: QoR15

Measured by QoR15 (Part A: 0 to 10 where 0=none of the time [poor] and 10=all the time [excellent]; Part B: 0 to 10 where 10=none of the time [poor] and 0=all the time [excellent])

Opioid Related Side Effects

Measured by 10 symptom ORSDS (symptom frequency: rarely to almost constantly; symptom severity: slight to very severe; symptom distress: not at all to very much)

Blinding Assessment

Measured by bang blinding index (choose between two treatment arms and provide explanation as to why arm was chosen)

Time to Opioid Use

Time to pressing IV PCA and to requesting first oral opioid

Total Opioid Consumption

Measured in mean oral morphine equivalents (OME)

Total Opioid Consumption

Measured in mean oral morphine equivalents (OME)

Full Information

NCT ID

NCT04156581

First Posted

October 25, 2019

Last Updated

September 23, 2022

Sponsor

Hospital for Special Surgery, New York

1. Study Identification

Unique Protocol Identification Number

NCT04156581

Brief Title

Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery

Acronym

ESPB-Spine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

October 14, 2019 (Actual)

Primary Completion Date

June 18, 2022 (Actual)

Study Completion Date

June 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Use, Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ESPB with Bupivacaine and Dexamethasone

Arm Type

Active Comparator

Arm Description

Arm Title

ESPB with saline placebo

Arm Type

Placebo Comparator

Arm Description

23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight.

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone is a corticosteroid that reduces inflammation.

Intervention Type

Other

Intervention Name(s)

Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Total Opioid Consumption

Description

Measured in mean oral morphine equivalents (OME)

Time Frame

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

Secondary Outcome Measure Information:

Title

Pain Scores at Rest

Description

Measured by Numeric Rating Scale (NRS) pain at rest (0 being no pain and 10 being as bad as you can imagine)

Time Frame

at baseline (holding area), PACU (hour 0), hour 6, 12, and 24 hours after surgery

Title

Pain Scores with Physical Therapy

Description

Measured by Numeric Rating Scale (NRS) pain with movement (0 being no pain and 10 being as bad as you can imagine)

Time Frame

on post-operative physical therapy day 0, 1, and 2

Title

Quality of Recovery: QoR15

Description

Measured by QoR15 (Part A: 0 to 10 where 0=none of the time [poor] and 10=all the time [excellent]; Part B: 0 to 10 where 10=none of the time [poor] and 0=all the time [excellent])

Time Frame

at baseline (holding area), 24 and 72 hours after surgery

Title

Opioid Related Side Effects

Description

Measured by 10 symptom ORSDS (symptom frequency: rarely to almost constantly; symptom severity: slight to very severe; symptom distress: not at all to very much)

Time Frame

at 24 hours after surgery

Title

Blinding Assessment

Description

Measured by bang blinding index (choose between two treatment arms and provide explanation as to why arm was chosen)

Time Frame

at 72 hours after surgery

Title

Time to Opioid Use

Description

Time to pressing IV PCA and to requesting first oral opioid

Time Frame

up to 24 hours after surgery

Title

Total Opioid Consumption

Description

Measured in mean oral morphine equivalents (OME)

Time Frame

0-12 hours after surgery (intraoperative + immediately after surgery)

Title

Total Opioid Consumption

Description

Measured in mean oral morphine equivalents (OME)

Time Frame

13-24 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ellen Soffin, MD, PhD

Organizational Affiliation

Hospital for Special Surgery, New York

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital for Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Certain individual participant data will be available. Individual participant data that underlie the results reported in a future article, after deidentification (text, tables, figures, appendices).

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal.

Learn more about this trial

Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery

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