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

Post Operative Pain Clinical Trial

Official title:

Ultrasound-guided Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Post-operative Analgesia in Inguinal Hernia Repair Under General Anesthesia: a Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05565365
• Other study ID #: SM 10 2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: September 2022
• Source: Assiut University
• Contact: Seham M. Moeen, MD
• Phone: 01006386324
• Email: seham.moeen[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia, Inguinal
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intensity of postoperative pain	Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)	24 hours after surgery