Efficacy of Adding Dexmedetomidine as an Adjuvant to Bupivacaine in TAP Block and Caudal Block

NCT04926454 | Unknown Phase 1

• 1 other identifier: FMASU M S 484 / 2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the efficacy of Dexmedetomidine as an adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block versus Caudal Block for post-operative analgesia in children undergoing congenital inguinal hernia repair especially to provide prolonged post-operative analgesia and decrease opioid consumption.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• When Dexmedetomidine is administered in combination with local anesthetics in the epidural space, it has been shown to reduce postoperative analgesic requirements and have a significantly analgesic effect"

  The primary outcome measures were the time to first analgesia (in minutes from the time of caudal (or) TAP block injection to first registration of modified VAS scale ≥3 at any point of time will receive paracetamol 10mg/kg orally

  Within 24 hours post operative

Study Arms (2)

TAP block

EXPERIMENTAL

patients will receive general anesthesia followed by Tap block at the end of the operation.

Drug: Dexmedetomidine

Caudal block

EXPERIMENTAL

patients will receive general anesthesia followed by caudal block at the beginning of the operation.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Patients will be monitored using standard monitoring (heart rate, non-invasive blood pressure, ECG and pulse oximetery) After the child is adequately anesthetized, intra-venous access with appropriate size cannula will be obtained Appropriate size LMA (2 and 2.5) will be inserted and patients will be allowed to breathe spontaneously. patients will receive 0.25% Bupivacaine (0.3ml/Kg) with 1 μg/kg dexmedetomidine After general anaesthesia

Also known as: Bupivacaine

Caudal block; TAP block

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 2-12 years
• Elective congenital inguinal hernia repair operation under general anaesthesia.
• Physical Status: ASA I and II Patients after taking written and informed consent from the parents or care giver.

You may not qualify if:

• Refusal of procedure or participation in the study by parents.
• Physical status: ASA III or above.
• Children undergoing bilateral lower abdominal surgeries.
• Infection at site of injection.
• Congenital anomaly of the spine.
• History of developmental delay, neurological disease, skeletal deformities.
• History or evidence of coagulopathy.
• Allergies to drugs used (Bupivacaine 0.5%)( dexmedetomidine/prcedex)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams Hospitals

Cairo, 02, Egypt

RECRUITING

Related Links

• Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis
• Effect of adding dexamethasone to bupivacaine on transversus abdominis plane block for abdominal hysterectomy: A prospective randomized controlled trial
• Cutaneous flexion reflex in human neonates: a quantitative study of threshold and stimulus-response characteristics after single and repeated stimuli
• Assessment and management of inguinal hernia in infants
• Effect of low dose dexmedetomidine premedication on propofol consumption in geriatric end stage renal disease patients
• Intraoperative dexmedetomidine attenuates postoperative systemic inflammatory response syndrome in patients who underwent percutaneous nephrolithotomy: a retrospective cohort study
• Caudal anesthesia in pediatrics: an update
• Analgesic effect of perineural magnesium sulphate for sciatic nerve block for diabetic toe amputation: A randomized trial
• Applications of regional anaesthesia in paediatrics
• Comparison of Dexmedetomidine and Fentanyl as an Adjuvant to Ropivacaine for Postoperative Epidural Analgesia in Pediatric Orthopedic Surgery
• Analgesia Following Arthroscopy - a Comparison of Intra-articular Bupivacaine and/or Midazolam and or Fentanyl
• Transversus abdominis plane block in children: a multicenter safety analysis of 1994 cases from the PRAN (Pediatric Regional Anesthesia Network) database
• Epidemiology and morbidity of regional anaesthesia in children
• Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bahaa Eldeen Ewis, Professor

  Professor of Anesthesia, intensive care and pain management

  STUDY CHAIR

Central Study Contacts

Elsayed Mohamed Ali Mohamed, M.B.B.Ch

CONTACT

+201069907186; Sayedsharkawy66@gmail.com

Mohamed Mohamed kamal, Lecturer

CONTACT

+20 100 378 7898; dr_medo2000@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: June 15, 2021
• Study Start: September 22, 2020
• Primary Completion: October 25, 2021
• Study Completion: October 30, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)