Dexmedetomidine Versus Clonidine in TAP Block

NCT03155646 | Completed Phase 2

• 1 other identifier: TAP block
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transversus Abdominis Plane Block

Keywords

TAP block; Dexmedetomidine; Clonidine

Outcome Measures

Primary Outcomes (1)

• modified CHEOPS

  postoperative pain assessment score in children

  24 hours

Secondary Outcomes (3)

• sedation score

  24 hours

• 5-point Likert scale

  24 hours

• complications

  24 hours

Study Arms (3)

DEXMEDETOMIDINE

ACTIVE COMPARATOR

patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml each side + 0.5 ug/kg dexmedetomidine Hydrochloride dissolved in 2 ml normal saline (NaCl 0.9%).

Drug: Dexmedetomidine

CLONIDINE

ACTIVE COMPARATOR

patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 0.5 ug/kg clonidine dissolved in 2 ml normal saline (NaCl 0.9%).

Drug: Clonidine

LEVOBUPIVACAINE

ACTIVE COMPARATOR

patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (NaCl 0.9%).

Drug: Levobupivacaine

Interventions

Dexmedetomidine DRUG

patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml each side + 0.5 ug/kg dexmedetomidine Hydrochloride dissolved in 2 ml normal saline (NaCl 0.9%)

DEXMEDETOMIDINE

Clonidine DRUG

patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 0.5 ug/kg clonidine dissolved in 2 ml normal saline (NaCl 0.9%)

CLONIDINE

Levobupivacaine DRUG

patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (NaCl 0.9%).

Also known as: Control

LEVOBUPIVACAINE

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I-II physical status patients.
• Age between 3 and 8 years.
• Children undergoing laparoscopic orcheopexy.

You may not qualify if:

• Parent refusal
• History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
• Hypersensitivity to any local anesthetics
• Bleeding diathesis
• History of renal, hepatic, cardiac, upper or lower airway or neurological diseases
• Any sign of infection at the puncture site of the proposed block
• History of sleep apnea with which postoperative ventilation may be required

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (1)

• Mostafa MF, Hamed E, Amin AH, Herdan R. Dexmedetomidine versus clonidine adjuvants to levobupivacaine for ultrasound-guided transversus abdominis plane block in paediatric laparoscopic orchiopexy: Randomized, double-blind study. Eur J Pain. 2021 Feb;25(2):497-507. doi: 10.1002/ejp.1689. Epub 2020 Nov 17.

  PMID: 33128801 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Clonidine; Levobupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazolines; Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 16, 2017
• Study Start: June 10, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)