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

NCT ID: NCT06219837

Last Updated: 2024-01-23

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

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Postoperative Analgesia of Inguinal Hernia Repair in Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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

Group Type ACTIVE_COMPARATOR

bupivacaine injection by ultrasound guided transversalis fascia plane block

Intervention Type DRUG

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.

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

Group Type PLACEBO_COMPARATOR

bupivacaine injection by ultrasound guided transversalis fascia plane block

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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20 ml of 0.9% normal saline solution

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Rabab

lecture of anathesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa Zayed, Assistant professor

Role: STUDY_DIRECTOR

Cairo University

Belal Khater, Master

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Mohamed Mohamed, MD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Faculty of Medicine, Cairo University

Cairo, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rabab Sabry, MD

Role: CONTACT

01010792931

Omnia Kamel, MD

Role: CONTACT

01270 130326

Facility Contacts

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Rabab Sabry, MD

Role: primary

0101079 2931

Omnia Kamel, MD

Role: backup

01270 130326

Other Identifiers

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(TFP) block

Identifier Type: -

Identifier Source: org_study_id

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