Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery

September 14, 2017 updated by: Mona Ammar, Ain Shams University
Several regional anesthesia have been shown to improve postoperative outcomes in many studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane block (analogous to the TAP block but intended for the back) which targets the sensory component of the dorsal rami of the thoracolumbar nerves in patients undergoing back surgeries.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Early Phase 1

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

  • Egypt
      • Cairo, Egypt, 1234
        • Recruiting
        • Faculty of medicine
        • Contact:
          • Waleed Abdalla, MD

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

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with ASA 1 or 2 aged between 21years old up to 60 years old of both sex scheduled of back surgery

Exclusion Criteria:

  • Exclusion criteria will be patients refusal or inability to give an informed consent , history of relevant allergy to any of the drugs used in the procedure , previous lumbar spine surgery or back surgery with planed spinal fixation.

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Intervention
Thoracolumber interfascial plane block
Procedure: Thoracolumber interfascial plane block
Thoracolumber interfascial plane block versus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Score
Time Frame: 24 hrs postoperative
24 hrs postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Total morphine consumption
Time Frame: 24 hrs postoperative
24 hrs postoperative

Collaborators and Investigators

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

Sponsor

Ain Shams University

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)

May 8, 2017

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

September 14, 2017

First Posted (Actual)

September 18, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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