Subarachnoid Block Versus Ultrasound Guided Transversalis Fascia Plane Block for Postoperative Analgesia of Inguinal Hernia Repair in Adults

January 12, 2024 updated by: Rabab, Cairo University

Subarachnoid Block Versus Ultrasound Guided Transversalis Fascia Plane Block for Postoperative Analgesia of Inguinal Hernia Repair in Adults: A Randomized, Double Blinded, Controlled Trial

The aim of our study is to investigate the effect of the ultrasound guided transversalis fascia plane block on the postoperative opioid consumption as a part of multimodal analgesia in patients undergoing inguinal herniorrhaphy under spinal anesthesia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of our study is to investigate the efficacy of the ultrasound-guided transversalis fascia plane block as a postoperative analgesia as a part of multimodal analgesia in patients undergoing inguinal herniorrhaphy under spinal anesthesia.

The ultrasound (US)-guided transversalis fascia plane (TFP) block was first described by Hebbard in 2009. A local anesthetic (LA) injected between the transversus abdominis muscle, and its deep investing fascia will block the anterior and the lateral branches of the T12 and L1 nerves (4). The efficacy of this block has been demonstrated in iliac crest bone graft harvesting, caesarean section and inguinal herniorrhaphy

Study Type

Interventional

Enrollment (Estimated)

80

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 Contact

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients undergoing inguinal herniorrhaphy.
  • Patients 18-60 years.
  • ASA I and II.
  • Both sexes.
  • Having no contraindication for spinal anesthesia or TFP block.

Exclusion Criteria:

  • Refusal of regional anesthesia.
  • Infection in the back or at the site of injection for TFP block.
  • INR > 1.5.
  • Platelet count < 80000 per microliter of blood.
  • Patients known to be allergic to amide local anesthetics.
  • BMI greater than 35 kgm_2.
  • Opioid addiction.
  • Have communication problems that may hinder the assessement of pain postoperative.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bupivacaine group
the patient in this arm will receive 20 ml of 0.25% bupivacaine injection by ultrasound guided transversalis fascia block for inguinal herniorraphy
Drug: bupivacaine injection by ultrasound guided transversalis fascia plane block
With patients in a sitting position and after appropriate skin asepsis, a 25-G pencil-point spinal needle (Pencil Point Spinal Needle Set, Egemen International Ltd., Izmir, Turkey) will be inserted through the L3 to L4 or L4 to L5 intervertebral space and 15 mg of 0.5% hyperbaric bupivacaine (AstraZeneca Pharmaceuticals, Cambridge, United Kingdom) will be injected. Subsequently, the patients will be positioned supine.
Other Names:
  • 20 ml of 0.9% normal saline solution
Placebo Comparator: 20 ml of 0.9% normal saline solution
he patient in this arm will receive 20 ml of 0.9% normal saline solution by ultrasound guided transversalis fascia block for inguinal herniorraphy
Drug: bupivacaine injection by ultrasound guided transversalis fascia plane block
With patients in a sitting position and after appropriate skin asepsis, a 25-G pencil-point spinal needle (Pencil Point Spinal Needle Set, Egemen International Ltd., Izmir, Turkey) will be inserted through the L3 to L4 or L4 to L5 intervertebral space and 15 mg of 0.5% hyperbaric bupivacaine (AstraZeneca Pharmaceuticals, Cambridge, United Kingdom) will be injected. Subsequently, the patients will be positioned supine.
Other Names:
  • 20 ml of 0.9% normal saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total amount of postoperative morphine consumption during the first 24hrs postoperative.
Time Frame: First 24 hours postoperative
The patients will be evaluated regarding the first demand to rescue analgesia postoperatively. The pain will be assessed by the VAS score. It will be performed in the immediate post-operative period every 15 min for the first 60 min, 2 h, 4 h, 8h, 12h, 18 and 24 h. Breakthrough pain will be defined as VAS >4 at rest.
First 24 hours postoperative

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Mohamed Mohamed, MD, Cairo university
  • Study Director: Marwa Zayed, Assistant professor, Cairo university
  • Principal Investigator: Belal Khater, Master, Cairo 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)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Estimated)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (TFP) block

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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