Skip to main content
Clinical Trials/NCT03778671
NCT03778671
Completed
Phase 1

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

Assiut University1 site in 1 country90 target enrollmentJanuary 1, 2019

Overview

Phase
Phase 1
Intervention
Levobupivacaine
Conditions
Transversus Abdominis Block
Sponsor
Assiut University
Enrollment
90
Locations
1
Primary Endpoint
first analgesic request
Status
Completed
Last Updated
4 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ghada Mohammed AboelFadl

principal investigator

Assiut University

Eligibility Criteria

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.

Arms & Interventions

Group B

Patients will receive Levobupivacaine 5%

Intervention: Levobupivacaine

Group D

Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine .

Intervention: Dexmedetomidine Injection [Precedex]

Group F

Patients will receive Levobupivacaine 5% + 1µg/kg fentanyl

Intervention: fentanyl

Outcomes

Primary Outcomes

first analgesic request

Time Frame: 24 hours

first time to call for analgesia

Study Sites (1)

Loading locations...

Similar Trials