Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Analgesia in Inguinal Hernia Repair

NCT ID: NCT05565365

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2023-12-15

Brief Summary

Uncontrolled postoperative pain after inguinal hernia repair increases the incidence of postoperative complications.

Detailed Description

Inguinal hernia repair is one of the most common surgical procedures in the world. Annually, more than 20 million inguinal hernia repairs are conducted worldwide.

Uncontrolled postoperative pain increases the incidence of postoperative complications. Regional blocks, as a part of multimodal analgesia, can improve pain control in the postoperative period and reduce complications that may arise from using a single mode of analgesia. For example, reliance on opioid analgesia increases the incidence of pruritus, nausea, and vomiting, as well as respiratory depression.

Hebbard first described the ultrasound (US)-guided transversalis fascia plane (TFP) block 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.

Erector spinae plane block (ESPB) is a type of facial plane block in which local anesthetic is administered in the plane located between the erector spinae muscle and thoracic transverse process. ESPB blocks the transmission of nociceptive stimuli through the dorsal/ventral rami of the spinal nerve roots, prevents afferent stimuli transmission, and inhibits efferent activation of the sympathetic nervous system and can thus provide both somatic and visceral sensory blockade, which would make it an ideal regional anesthetic technique for abdominal surgery.The effect of ESPB is also achieved through the block of the lateral, posterior, and anterior thoracic wall resulting in multiple levels sensory blocks. Additional proposed mechanism of action could be explained by the epidural spread of the anesthetics.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Transversalis fascia plane (TFP) block

Patients will receive unilateral US-TFP block with bupivacaine 15 minutes before skin incision

Group Type: PLACEBO_COMPARATOR

Transversalis fascia plane (TFP) block

Intervention Type: PROCEDURE

Patients will receive unilateral US-TFP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision

Erector Spinae Plane (ESP) Block

Patients will receive unilateral US-ESP block with bupivacaine 15 minutes before skin incision

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane (ESP) Block

Intervention Type: PROCEDURE

Patients will receive unilateral US-ESP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision

Interventions

Transversalis fascia plane (TFP) block

Patients will receive unilateral US-TFP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision

Intervention Type: PROCEDURE

Erector Spinae Plane (ESP) Block

Patients will receive unilateral US-ESP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision

Intervention Type: PROCEDURE

Other Intervention Names

TFP block; ESP Block

Eligibility Criteria

Inclusion Criteria

• Male patients undergoing elective open unilateral inguinal hernia repair under general anesthesia, ASA status I-II, aged from 20 to 65 years old

Exclusion Criteria

• Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
• Altered cognitive function
• Body mass index (BMI > 35 kg/m2)
• Patients who have difficulty understanding the study protocol
• Patients who have any known allergy to study medications
• Advanced hepatic or renal failure
• Chronic opioid consumption
• Patient refusal

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Seham Mohamed Moeen Ibrahim

Assistant professor of Anesthesia and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Seham M. Moeen, MD

Role: CONTACT

seham.moeen@aun.edu.eg

01006386324 ext. 02

Israa M. Abd El-Rahman, Msc

Role: CONTACT

israamohamedvip@gmail.com

01060019510 ext. 02

Other Identifiers

SM 10 2022

Identifier Type: -

Identifier Source: org_study_id