Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery

Study Overview
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Brief Summary
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The perioperative management of pain following abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. These include nausea, vomiting, pruritus, urinary retention, constipation, respiratory depression, and sedation.

Detailed Description
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As a result, the goal to reduce perioperative pain has taken on a multimodal approach. Multimodal or balanced analgesia uses a combination of opioid and nonopioid analgesics to improve pain control and minimize opioid-related side effects. These include the use of nonsteroidal anti-inflammatory drugs, local anesthetics, peripheral nerve blocks, gabapentinoids, and alpha2 adrenergic agonists. Any combination of these therapies can help reduce the surgical stress response and improve patient outcomes such as pain control, patient satisfaction, time to discharge, and return to daily activities. One method used in this multimodal approach is the transversus abdominis plane block. As first described by Rafi in 2001, this block provides analgesia to the anterolateral abdominal wall. In 2007, further studied this technique in patients undergoing large-bowel resection. He discovered a reduction in postoperative pain and morphine consumption in the first 24 hours postoperatively, resulting in fewer opioid-mediated side effects. In this same year, Hebbard described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve TAP block accuracy. In 2008, Hebbard. described the subcostal approach of TAP blocks, to target the nerves of the upper abdomen. Transversus abdominis plane blocks continue to be studied and developed as an effective method for providing analgesia for numerous types of abdominal surgeries.

Official Title
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Addition of Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery: Could it Make a Difference?

Conditions
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Dexmedetomidine, Fentanyl

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Dexmedetomidine Hydrochloride
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA status I, II, and III patients, aged 60-75 y, both male and female, undergoing inguinal hernia repair surgery. Exclusion Criteria: morbid obesity (BMI > 40), spine metastatic tumor, allergy to an amide LA, or magnesium sulfate, heart block, renal, or liver dysfunction, substance abuse disorder, chronic opioid use, or electrolyte disturbance, administration of any sedative, preexisting mental illness, psychological or emotional problems.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group L<br>30 Patients will receive Levobupivacaine 5% | Drug: Levobupivacaine<br>* Levobupivacaine 5%<br>|
| Experimental: LD group<br>30 patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomidine. | Drug: Dexmedetomidine Hydrochloride<br>* Levobupivacaine 5% + 1 µg/kg dexmedetomidine.<br>|
| Experimental: LF group<br>30 patients will receive Levobupivacaine 5% + 1µg/kg fentanyl | Drug: Fentanyl<br>* Levobupivacaine 5% + 1µg/kg fentanyl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first analgesic request | time for the first analgesia rescue call. | 24 hours postoperative |