Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Analgesia in Inguinal Hernia Repair
Primary Purpose
Post Operative Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transversalis fascia plane (TFP) block
Erector Spinae Plane (ESP) Block
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Transversalis fascia plane (TFP) block
Erector Spinae Plane (ESP) Block
Arm Description
Patients will receive unilateral US-TFP block with bupivacaine 15 minutes before skin incision
Patients will receive unilateral US-ESP block with bupivacaine 15 minutes before skin incision
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05565365
First Posted
September 30, 2022
Last Updated
September 30, 2022
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT05565365
Brief Title
Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Analgesia in Inguinal Hernia Repair
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 14, 2022 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transversalis fascia plane (TFP) block
Arm Type
Placebo Comparator
Arm Description
Patients will receive unilateral US-TFP block with bupivacaine 15 minutes before skin incision
Arm Title
Erector Spinae Plane (ESP) Block
Arm Type
Active Comparator
Arm Description
Patients will receive unilateral US-ESP block with bupivacaine 15 minutes before skin incision
Intervention Type
Procedure
Intervention Name(s)
Transversalis fascia plane (TFP) block
Other Intervention Name(s)
TFP block
Intervention Description
Patients will receive unilateral US-TFP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane (ESP) Block
Other Intervention Name(s)
ESP Block
Intervention Description
Patients will receive unilateral US-ESP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision
Primary Outcome Measure Information:
Title
The intensity of postoperative pain
Description
Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)
Time Frame
24 hours after surgery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seham M. Moeen, MD
Phone
01006386324
Ext
02
Email
seham.moeen@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Israa M. Abd El-Rahman, Msc
Phone
01060019510
Ext
02
Email
israamohamedvip@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Analgesia in Inguinal Hernia Repair
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