Comparison of M-TAPA and TAP Blocks on Postoperative Analgesia in Laparoscopic Inguinal Hernia Surgeries
Comparison of the Analgesic Effects of Modified Thoracoabdominal Nerve Block Through Pericondrial Approach (M-TAPA) and Transversus Abdominis Plane (TAP) Block in Laparoscopic Inguinal Hernia Surgeries
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: oğuz gündoğdu
- Phone Number: +905545945469
- Email: droguzgundogdu@gmail.com
Study Contact Backup
- Name: Onur Avcı
- Phone Number: +905301126408
- Email: dronuravci@gmail.com
Study Locations
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Si̇vas
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Sivas, Si̇vas, Turkey (Türkiye), 58140
- Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients older than 18 years of age who will undergo laparoscopic inguinal hernia under general anesthesia and will be American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Exclusion Criteria:
- Patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
- patients undergoing open surgery,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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No Intervention: CONTROL
Control group patients are not going to be subjected to any block or local infiltration anesthesia.
Their postoperative pain will be relieved with ibuprofen and tramadol (intravenous) administrations.
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Active Comparator: M-TAPA
Patients will have bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.
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Following sterile conditions for bilateral M-TAPA block application, the transducer will be inserted on the chondrium in the sagittal plane at the 9-10th rib level.
Subsequently, a deep angle will be created with the probe for visualization of the underside of the costochondrium.
The sonovisible needle tip will be placed just below the chondrium and saline (5 ml) will be injected for site confirmation.
After the confirmation, 20 ml of 0.25% bupivacaine will be administered for each group for a total of 40 ml of local anesthetic.
Blocks will be applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound.
M-TAPA block with the same standard technique and drug dose will be applied to the contralateral side for each group of M-TAPA patients.
Other Names:
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Active Comparator: TAP
Patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.
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After the necessary sterilization conditions established, the linear ultrasound probe will be placed in the middle of the iliac crest with the end limit of the ribs.
Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum will be identified.
As the tip of the 80 mm sonovisible needle passes through the muscular layers and fascia, the needle will be advanced in a controlled manner.
After receiving the click sensation (passage of the fascia of the internal oblique muscle), the location of the needle will be fixed and 20 ml of 0.25% bupivacaine will be injected between internal oblique and transversus abdominis muscles.
Same procedure will be performed to the other site.
(40 ml local anesthetics in total)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparing the numerical rating scale scores
Time Frame: Postoperative 24 hours
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Numerical rating scale will be used for pain assessment.
The scores of the numerical rating scale changes between 0 to 10 points.
10 points mean "the most severe pain that the patient ever had".
0 point means "there is no pain."
Higher scores mean worse outcome.
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Postoperative 24 hours
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparing total tramadol consumption
Time Frame: Postoperative 24 hours
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Postoperative analgesic need
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Postoperative 24 hours
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: OĞUZ GÜNDOĞDU, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
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
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
Other Study ID Numbers
- Comparison of M-TAPA and TAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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