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

A

Assiut University

Status

Not yet enrolling

Conditions

Post Operative Pain

Treatments

Procedure: Transversalis fascia plane (TFP) block
Procedure: Erector Spinae Plane (ESP) Block

Study type

Interventional

Funder types

Other

Identifiers

NCT05565365
SM 10 2022

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Transversalis fascia plane (TFP) block
Placebo Comparator group
Description:
Patients will receive unilateral US-TFP block with bupivacaine 15 minutes before skin incision
Treatment:
Procedure: Transversalis fascia plane (TFP) block
Erector Spinae Plane (ESP) Block
Active Comparator group
Description:
Patients will receive unilateral US-ESP block with bupivacaine 15 minutes before skin incision
Treatment:
Procedure: Erector Spinae Plane (ESP) Block

Trial contacts and locations

0

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Central trial contact

Seham M. Moeen, MD; Israa M. Abd El-Rahman, Msc

Data sourced from clinicaltrials.gov

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