- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05565365
Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Analgesia in Inguinal Hernia Repair
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Asyut, Egypt
- Assiut University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Transversalis fascia plane (TFP) block
Patients will receive unilateral US-TFP block with bupivacaine 15 minutes before skin incision
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Patients will receive unilateral US-TFP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision
Other Names:
|
|
Active Comparator: Erector Spinae Plane (ESP) Block
Patients will receive unilateral US-ESP block with bupivacaine 15 minutes before skin incision
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Patients will receive unilateral US-ESP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The intensity of postoperative pain
Time Frame: 24 hours after surgery
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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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Behavioral Disciplines and Activities
- Digestive System and Oral Physiological Phenomena
- Behavioral Sciences
- Dentistry
- Dental Physiological Phenomena
- Dental Occlusion
- Parapsychology
Other Study ID Numbers
- SM 10 2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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