Comparison Between the Analgesic Efficacy of Erector Spinae Plane Block and Psoas Compartment Block in Hip Surgery

April 4, 2019 updated by: Sibel Seçkin Pehlivan, TC Erciyes University
To evaluate the ability of Erector spina Plane block and Psoas compartment block to decrease postoperative pain and analgesia requirements in patients undergoing hip surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Erector spina Plane block or Psoas compartment block will performed with guided ultrasound at L4 Transverse process level would lead to adequate postoperative analgesia ,in total hip arthroplasty surgeries.

Study Type

Interventional

Enrollment (Anticipated)

105

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
    • Talas
      • Kayseri, Talas, Turkey, 38039
        • Sibel Seckin Pehlivan

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 (American Society of Anesthesiologists) I- ASA II Patients

-

Exclusion Criteria:

  • history of allergy to the study medication
  • refusal to participate

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: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Psoas compartment block group (PCB)
Single- shot ultrasound (Esaote Mylab30) guided PCB with 15 ml 0.25% bupivacain ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the PCB group (Group I).
Procedure: Psoas Compartment Block Group (GROUP I)
Psoas Compartment Block will perform preoperative to all patients in Group I. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
ACTIVE_COMPARATOR: Erector spinae plane block group (ESP)
Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the ESP group (Group II).
Procedure: Erector Spinae Plane block ( Group II)
ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
PLACEBO_COMPARATOR: The Control group
The Control group receive no intervention ( Group III).
Procedure: Control Group (GROUP III)
Control group will receive no intervention. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: 24 hours after surgery
In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
24 hours after surgery
Verbal analog Pain Scores on rest and movement
Time Frame: 24 hours after surgery
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidences of adverse effects (like nausea and vomiting)
Time Frame: 24 hours after surgery
incidences of nausea and vomiting during the 24 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24 hours).
24 hours after surgery

Collaborators and Investigators

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

Sponsor

TC Erciyes University

Investigators

  • Study Director: Sibel Pehlivan, TC Erciyes 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

Helpful Links

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)

February 1, 2019

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

February 1, 2022

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (ACTUAL)

April 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/98

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 12 months of study completion

IPD Sharing Access Criteria

Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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