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

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Fentanyl; Dexmedetomidine

Treatments: Drug: Dexmedetomidine Hydrochloride; Drug: Levobupivacaine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT04971759

17300618

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Group L

Experimental group

Description:

30 Patients will receive Levobupivacaine 5%

Treatment:

Drug: Levobupivacaine

LD group

Experimental group

Description:

30 patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomidine.

Treatment:

Drug: Dexmedetomidine Hydrochloride

LF group

Experimental group

Description:

30 patients will receive Levobupivacaine 5% + 1µg/kg fentanyl

Treatment:

Drug: Fentanyl