Erector Spinae Plane Block For Lumbar Disc Hernia Repair

February 4, 2020 updated by: Dilek İçli, Kocaeli University

The Effect Of Erector Spinae Plane Block On Postoperative Pain Management In Lumbar Disc Hernia Repair Operation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Erector Spinae Plane Block

Erector Spinae Plane Block Group

Block Drug: 0,25% bupivacaine hydrochloride (20ml) will be used for blocks
Procedure: Erector Spinae Plane block
Erector Spinae plane block will be done according to hernia level using bupivacaine hydrochloride
Drug: Bupivacaine Hydrochloride
20 ml 0,25% Bupivacaine will be used for block performances
Device: PCA
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
SHAM_COMPARATOR: Control Group
Sham block will be done with serum physiologic.
Device: PCA
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
Procedure: Sham block
Sham block will be done with serum physiologic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: postoperative first 24 hour
morphine consumptions will be recorded
postoperative first 24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale
Time Frame: postoperative first 24 hour
Numeric rating scale for pain will be used for pain evaluation. The scale is scored in a range of 0-10 with 0 representing no pain 10 representing the highest degree of pain.
postoperative first 24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Dilek Icli, Kocaeli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

February 4, 2020

Study Registration Dates

First Submitted

November 15, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (ACTUAL)

November 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KİA2018/440

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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