Transversus Abdominis Plane Block Using Dexmedetomidine and Bupivacaine

NCT03156296 | Completed Phase 2

• 1 other identifier: ultrasound guided TAP block
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric laparoscopy has been first described in 1923 by Kelling but its use has increased since last decade. 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; shortens postoperative convalescence, including an intensive care unit stay; rapid return to normal diet and decreased overall hospital stay. Despite the minimally invasive nature, pain can be moderate to severe in the immediate postoperative period. 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. Analgesic multimodalities were recommended to relieve the post-operative pain. Opioids although provide satisfactory analgesia, they are associated with unwanted side-effects. Transversus abdominis plane (TAP) block is a type of peripheral nerve block that involves innervations of the anterolateral abdominal wall. It provides adequate post-operative pain relieve following various abdominal surgeries. With the aid of ultrasound or anatomical landmark guidance, local anesthetic (LA) is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located. Ultrasound TAP block is also 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.

Conditions

Laparoscopic Orcheopexy

Keywords

transversus abdominis plane block , Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• CHEOPS

  postoperative pain assessment score in children

  24 hours

Secondary Outcomes (2)

• Time to first analgesia

  24 hours

• 5-point Likert scale

  24 hours

Study Arms (2)

BUPIVACAINE

ACTIVE COMPARATOR

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

Drug: Bupivacaine

DEXMEDETOMIDINE

ACTIVE COMPARATOR

patients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 0.25 mg/kg dexmedetomidine dissolved in 2 ml normal saline (0.9%)

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

patients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 0.25 mg/kg dexmedetomidine dissolved in 2 ml normal saline (0.9%)

DEXMEDETOMIDINE

Bupivacaine DRUG

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

BUPIVACAINE

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

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 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 17, 2017
• Study Start: June 10, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)