Dexmedetomidine Versus Fentanyl Added to Levobupivacaine for Transversus Abdominis Plane (TAP) Block

Study Overview
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Brief Summary
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The perioperative management of pain following lower 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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One method used in this multimodal approach is the transversus abdominis plane block. This block, as first described by Rafi. in 2001, provides analgesia to the anterolateral abdominal wall. In 2007, McDonnell et al. 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 et al. described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve transversus abdominis plane block accuracy. In 2008, Hebbard. described the subcostal approach of transversus abdominis plane block, 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 transverses abdominis plane block duration is limited to effect of administered local anesthetics.The use of an infusion catheter to administer local anesthetics is an option to prolong the block's duration. Recently, adjuvant medications were added to local anesthetics to prolong the effect of transverses abdominis plane block .

Official Title
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Dexmedetomidine Versus Fentanyl Added to Levobupivacaine for Transversus Abdominis Plane (TAP) Block in Elderly Patients Undergoing Lower Abdominal Surgery

Conditions
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Transversus Abdominis Block

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Dexmedetomidine Injection [Precedex]
* Drug: fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status II-III, scheduled for uncomplicated elective paraumbilical hernia repair. Exclusion Criteria: Patient refusal to participate in the study Patients with coagulopathy or under anticoagulation therapy. Infection near the site of needle insertion. Body mass index > 40kg/m2 Patients with any neurological or neuromuscular disorder or history of seizures.

Ages Eligible for Study
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Minimum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B<br>Patients will receive Levobupivacaine 5% | Drug: Levobupivacaine<br>* Patients will receive Levobupivacaine 5%<br>* Other names: Levobupivacaine hydrate;|
| Active Comparator: Group D<br>Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine . | Drug: Dexmedetomidine Injection [Precedex]<br>* Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine<br>|
| Active Comparator: Group F<br>Patients will receive Levobupivacaine 5% + 1µg/kg fentanyl | Drug: fentanyl<br>* Patients will receive Levobupivacaine 5% + 1 µg/kg fentanyl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first analgesic request | first time to call for analgesia | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transversus abdominis plane block, Dexmedetomidine, Fentanyl