NCT04749095

Brief Summary

The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

February 5, 2021

Last Update Submit

February 9, 2021

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Analgesia

    Numerical rating scale of pain every 6 hours

    Up to 24 hours after surgery

Study Arms (2)

Erector block

ACTIVE COMPARATOR
Drug: Erector spinae plane block

sham block

ACTIVE COMPARATOR
Drug: sham subcutaneous infiltration

Interventions

Erector spinae plane blockDRUG

bilateral ESP block will be injected with 20 ml of 0.25% bupivacaine

Erector block
sham subcutaneous infiltrationDRUG

bilateral ESP block will be injected with 20 ml of normal saline

sham block

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists class I-III adult patients
  • BMI less than or equal 35 kg/m2

You may not qualify if:

  • Patient refusal
  • unable to give consent
  • age \< 18 or \> 65
  • BMI more than 35 kg/m2
  • known allergy to the study medication
  • coagulopathies or on anticoagulant medications
  • hepatic insufficiency
  • renal insufficiency
  • chronic opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 11, 2021

Study Start

May 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

February 11, 2021

Record last verified: 2021-02