Erector Spinae Plane Block For Lumbar Disc Hernia Repair

NCT ID: NCT03744689

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-02-04

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Erector Spinae Plane Block

Erector Spinae Plane Block Group

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

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane block

Intervention Type PROCEDURE

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

Bupivacaine Hydrochloride

Intervention Type DRUG

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

PCA

Intervention Type DEVICE

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

Control Group

Sham block will be done with serum physiologic.

Group Type SHAM_COMPARATOR

Sham block

Intervention Type PROCEDURE

Sham block will be done with serum physiologic.

PCA

Intervention Type DEVICE

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

Interventions

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Erector Spinae Plane block

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

Intervention Type PROCEDURE

Sham block

Sham block will be done with serum physiologic.

Intervention Type PROCEDURE

Bupivacaine Hydrochloride

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

Intervention Type DRUG

PCA

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Dilek İçli

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Icli

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 33751203 (View on PubMed)

Other Identifiers

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KİA2018/440

Identifier Type: -

Identifier Source: org_study_id

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