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NCT03155646

Dexmedetomidine Versus Clonidine in TAP Block

Completed Phase 2, PHASE3 Last updated 20 August 2020
What this trial tests

Phase 2, PHASE3 trial testing Dexmedetomidine in Transversus Abdominis Plane Block in 90 participants. Completed in 1 August 2019.

Timeline
10 June 2017
Primary endpoint
1 August 2019
1 August 2019

Quick facts

Lead sponsorAssiut University
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment90
Start date10 June 2017
Primary completion1 August 2019
Estimated completion1 August 2019
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Assiut University

Who can join

Adults 3 to 8, male only, with Transversus Abdominis Plane Block. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A laparoscopic approach offers several advantages over an open procedures; potentially reduces the surgical stress and fluid shifts that may accompany it; in addition there is less need for postoperative analgesia, reduction of postoperative respiratory and wound complications. Despite the minimally invasive nature, pain can be moderate to severe in the immediate postoperative period that requires multimodal analgesia. Inadequate control of post-operative pain leads to several unwanted adverse events ranging from patients' discomfort and prolonged immobilization to thromboembolic phenomenon and pulmonary complications. Transversus abdominis plane (TAP) block is a type of peripheral nerve block that involves innervation of the anterolateral abdominal wall. With the aid of ultrasound, local anesthetic (LA) is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located. Ultrasound TAP block is accompanied by a good pain relief and reduced intraoperative and postoperative opioids requirements after laparoscopic surgery. In this case a bilateral TAP block is necessary because the abdominal skin incisions for the ports of laparoscopic procedure are performed on both sides. Unfortunately, TAP block duration is limited to the effect of administered LA. Recently, adjuvant medications were added to LA to prolong the effect of TAP block. Dexmedetomidine is a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Its use with bupivacaine either epidurally or intrathecally is associated with prolongation of the LA effect. A major advantage of dexmedetomidine is its higher selectivity compared with clonidine for α2A receptors, responsible for the hypnotic and analgesic effects of such drugs.10 Clonidine action, similar to local anesthetic action, and its interaction with local anesthetics have been explained by three possible mechanisms. First, clonidine blocks Ad and C fibers. Secondly, clonidine may cause local vasoconstriction, thus decreasing local anesthetic spread and removal around neural structures. Thirdly, clonidine used in peripheral blocks intensifies and prolongs analgesia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Dexmedetomidine

Trials testing the same drug.

Other recruiting trials for Transversus Abdominis Plane Block

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Other Assiut University trials

Trials by the same sponsor.

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Data sources for this page

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