Efficacy of Adding Dexmedetomidine as an Adjuvant to Bupivacaine in TAP Block and Caudal Block
NCT ID: NCT04926454
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2020-09-22
2021-10-30
Brief Summary
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Detailed Description
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Postoperatively, patients experience somatosensory pain from the incision site and visceral irritation and discomfort .
The impact of painful experience on the young nervous system is so significant that long-term effects can occur, including a lowered pain tolerance for months after a pain-producing event however, the benefits of adequate analgesia include attenuation of the surgical stress response, decreased perioperative morbidity and improved outcome in certain types of surgery. Also effective pain control facilitates rehabilitation and accelerates recovery from surgery .
Regional anesthesia and analgesia techniques are commonly used to facilitate pain control during pediatric surgical practice, decrease parenteral opioids requirements and improve the quality of post-operative pain control and patient-parent satisfaction.
Caudal epidural anesthesia is considered the gold standard regional technique for pain management after pediatric pelvic and lower abdominal procedures because it blocks both somatic and visceral pain. The caudal block has a low complication rate (0.7 per 1000) , provides 4 to 6 hours of analgesia, and results in improved patient pain scores than in patients having general anesthesia alone .
An increased understanding of abdominal wall anatomy has led to the introduction of the transversus abdominis plane block (TAPB) for managing pain after lower abdominal surgery .TAPB provides reliable unilateral sensory block in the T10-L1 distribution with a single injection, and resulted in a significant decrease in postoperative pain scores and opioid requirements after major abdominal surgeries . Similar outcomes have been observed in pediatric studies, and analgesia after TAPB in pediatric patients is thought to last 10 to 15 hours .
The technique of TAP block has been found to be a safe and effective tool in a variety of general, gynaecological, and urological surgery, and it is suggested as part of the multimodal anaesthetic approach to enhance recovery after lower abdominal surgeries .
However, the duration of analgesia provided by these strategies is limited by the short duration of action of the local anesthetic .
Various adjuvants to local anesthetics have been investigated to improve the quality of block and duration of analgesia, including Dexmedetomidine, fentanyl, morphine, ketamine, midazolam, and magnesium.
Each of these adjuvants has side effects specific to the type and dose of adjuvant used. For instance, behavioral changes have been noted with the use of caudal ketamine, opioids are associated with risk of respiratory depression, and the neurotoxicity of midazolam is still controversial. Therefore, an ideal adjuvant that provides maximal analgesia with minimal side effects for these blocks is still a matter of contention.
Dexmedetomidine (DEX) is a highly selective α2-adrenoceptor agonist, possesses sedative, analgesic, anxiolytic, and anti-inflammatory properties . When administered in combination with local anesthetics in the epidural space, it has been shown to reduce postoperative analgesic requirements and have a significantly
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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TAP block
patients will receive general anesthesia followed by Tap block at the end of the operation.
Dexmedetomidine
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
Caudal block
patients will receive general anesthesia followed by caudal block at the beginning of the operation.
Dexmedetomidine
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
Interventions
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Dexmedetomidine
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
2 Years
12 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Principal Investigators
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Bahaa Eldeen Ewis, Professor
Role: STUDY_CHAIR
Professor of Anesthesia, intensive care and pain management
Locations
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AinShams Hospitals
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Related Links
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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
Other Identifiers
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FMASU M S 484 / 2020
Identifier Type: -
Identifier Source: org_study_id