NCT03744689

Brief Summary

Pain management after lomber disc hernia repair surgery is a challenging issue for anesthetists. Erector Spinae plane block is a novel analgesic technique which could be used for this purpose. Primary aim of this double blinded randomized controlled study is to compare the analgesic efficacy of this new block technique with control group in this group of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

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

November 15, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

November 15, 2018

Last Update Submit

February 4, 2020

Conditions

Postoperative Pain

Keywords

Lomber disc herniaErector spinae plane blockPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    morphine consumptions will be recorded

    postoperative first 24 hour

Secondary Outcomes (1)

  • Numeric rating scale

    postoperative first 24 hour

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

Erector Spinae Plane Block Group Block Drug: 0,25% bupivacaine hydrochloride (20ml) will be used for blocks

Procedure: Erector Spinae Plane blockDrug: Bupivacaine HydrochlorideDevice: PCA

Control Group

SHAM COMPARATOR

Sham block will be done with serum physiologic.

Procedure: Sham blockDevice: PCA

Interventions

Erector Spinae Plane blockPROCEDURE

Erector Spinae plane block will be done according to hernia level using bupivacaine hydrochloride

Erector Spinae Plane Block
Sham blockPROCEDURE

Sham block will be done with serum physiologic.

Control Group
Bupivacaine HydrochlorideDRUG

20 ml 0,25% Bupivacaine will be used for block performances

Erector Spinae Plane Block
PCADEVICE

Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded

Control GroupErector Spinae Plane Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II
  • Age 18-65 years
  • Undergoing elective lomber disc hernia

You may not qualify if:

  • obesity
  • ASA III - IV
  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (1)

  • Yorukoglu HU, Icli D, Aksu C, Cesur S, Kus A, Gurkan Y. Erector spinae block for postoperative pain management in lumbar disc hernia repair. J Anesth. 2021 Jun;35(3):420-425. doi: 10.1007/s00540-021-02920-0. Epub 2021 Mar 22.

    PMID: 33751203DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacainePassive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesSkin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Study Officials

  • Dilek Icli

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 16, 2018

Study Start

October 1, 2019

Primary Completion

February 1, 2020

Study Completion

February 4, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

TU(1)