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

Phase 2

Completed

• Conditions: Fentanyl; Dexmedetomidine
• Interventions: Drug: Levobupivacaine; Drug: Fentanyl; Drug: Dexmedetomidine Hydrochloride

• Registration Number: NCT04971759
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-02-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-07-21
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	Levobupivacaine	30 Patients will receive Levobupivacaine 5%
LF group	Fentanyl	30 patients will receive Levobupivacaine 5% + 1µg/kg fentanyl
LD group	Dexmedetomidine Hydrochloride	30 patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomidine.

Primary Outcome Measures

Name	Time	Method
first analgesic request	24 hours postoperative	time for the first analgesia rescue call.

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt