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

Phase 1

Completed

• Conditions: Transversus Abdominis Block
• Interventions: Drug: Dexmedetomidine Injection [Precedex]; Drug: fentanyl; Drug: Levobupivacaine

• Registration Number: NCT03778671
• Lead Sponsor: Assiut University

Brief Summary

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

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 .

Study Timeline

• Study First Submitted: 2018-12-16
• Study First Submitted QC: 2018-12-16
• Study First Posted: 2018-12-19
• Study Start: 2019-01-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

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

Inclusion Criteria

• ASA physical status II-III,
• scheduled for uncomplicated elective paraumbilical hernia repair.

Exclusion Criteria

1. Patient refusal to participate in the study
2. Patients with coagulopathy or under anticoagulation therapy.
3. Infection near the site of needle insertion.
4. Body mass index > 40kg/m2
5. Patients with any neurological or neuromuscular disorder or history of seizures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group D	Dexmedetomidine Injection [Precedex]	Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine .
Group F	fentanyl	Patients will receive Levobupivacaine 5% + 1µg/kg fentanyl
Group B	Levobupivacaine	Patients will receive Levobupivacaine 5%

Primary Outcome Measures

Name	Time	Method
first analgesic request	24 hours	first time to call for analgesia

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt