Skip to main content
OpenTrials
Completed

NCT Number: NCT03778671

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Assiut governorate

Asyut, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine

Drug

Patients will receive Levobupivacaine 5%

Other names: Levobupivacaine hydrate

Dexmedetomidine Injection [Precedex]

Drug

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

Fentanyl

Drug

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

Primary outcomes

  1. first analgesic request

    Time frame: 24 hours

    first time to call for analgesia

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.