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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-02-01

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.

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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.

Conditions

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Dexmedetomidine Fentanyl

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group L

30 Patients will receive Levobupivacaine 5%

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type DRUG

Levobupivacaine 5%

LD group

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

Group Type EXPERIMENTAL

Dexmedetomidine Hydrochloride

Intervention Type DRUG

Levobupivacaine 5% + 1 µg/kg dexmedetomidine.

LF group

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

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Levobupivacaine 5% + 1µg/kg fentanyl

Interventions

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Levobupivacaine

Levobupivacaine 5%

Intervention Type DRUG

Dexmedetomidine Hydrochloride

Levobupivacaine 5% + 1 µg/kg dexmedetomidine.

Intervention Type DRUG

Fentanyl

Levobupivacaine 5% + 1µg/kg fentanyl

Intervention Type DRUG

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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No