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Nalbuphine Plus Caudal Bupivacaine in Hypospadius Repair

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nalbuphine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

2 Years - 10 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male children undergoing hypospadius repair, with an American Society of Anesthesiologists (ASA) physical status I.

Exclusion Criteria:

  • Guardians refusal.
  • Contraindication to caudal block such as:

    • Patients with congenital anomalies at the lower spine or meninges.
    • Patients with increased intracranial pressure.
    • Patients with skin infection at the site of injection.
    • Patients with bleeding diathesis.
    • Know allergy to any drug used in this study.

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

A

B

Arm Description

children undergoing hypospadius repair given 1 ml/kg of bupivicaine 0.25 % via caudal route to achieve post operative analgesia

children undergoing hypospadius repair given 1 ml/kg of bupivicaine 0.25 % plus 0.1 mg nalbuphine via caudal route to achieve post operative analgesia

Outcomes

Primary Outcome Measures

post operative pain measurement
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale

Secondary Outcome Measures

Full Information

First Posted
March 9, 2018
Last Updated
March 21, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03476772
Brief Title
Nalbuphine Plus Caudal Bupivacaine in Hypospadius Repair
Official Title
Nalbuphine as an Adjuvant to Caudal Bupivacaine for Postoperative Analgesia in Children Undergoing Hypospadius Repair
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Caudal aneasthesia for pediatric surgery was first reported in 1933. Since then, studies have described the indications for pediatric caudal block, the level of analgesia, doses, advantages and disadvantages of this technique. In children, caudal anesthesia is most effectively used as adjunct to general aneasthesia and has an opioid-sparing effect, permitting faster and smoother emergence from aneasthesia. A single shot caudal anesthesia provides relatively brief analgesia for 4 to 8 hours depending on the agent used. Prolongation of anesthesia can be achieved by adding various adjuvants, such as opioids and nonopioids such as clonidine, ketamine, midazolam, and neostigmine,with varying degrees of success.
Detailed Description
The somatic innervation of the lower urogenital system arises principally from the spinal nerves sacral 2 to sacral 4 by way of the pudendal nerve. After passing under the sacrospinous ligament and over the sacrotuberous ligament through Alcock's canal, the pudendal nerve passes through the transverse perineal muscle to course on the dorsum of the penis as the dorsal nerve of the penis. The dorsal nerve of the penis is thought to be a sensory nerve. The autonomic innervation of the penis arises from the vesical and prostatic plexus, which is composed of sympathetic nerves from lumbar 1 and lumbar 2, and parasympathetic nerves from sacral 2 to sacral 4. The cavernosal nerve leaves the pelvis between the transverse perineal muscles and the membranous urethra before passing beneath the arch of pubis to supply each corporal body. After the pudendal nerve leaves the pudendal canal, two main terminal branches arise, the inferior rectal and the perineal nerves. The function of the inferior rectal nerve is motor innervation of external anal sphincter and is thought to be devoid of urogenital function. Sensory portions of the inferior rectal nerve are important for perianal skin sensation. The perineal nerve has both a motor and sensory component. The motor efferents are known to innervate the pelvic musculature, mainly the bulbospongiosus muscle. To achieve complete anesthesia (analgesia) for hypospadius repair, afferent blockade must be complete at lumbar 1 through sacral 4. Nalbuphine is a mixed k-agonist and µ-antagonist opioid of the phenanthrene group; it is related chemically to naloxone and oxymorphone. Nalbuphine leads to activation of spinal and supraspinal opioid receptors which leads to good analgesia with minimal sedation, minimal nausea and vomiting, less respiratory depression and stable cardiovascular functions. Safety and efficacy of nalbuphine have been established in the clinical field and its safety and efficacy also established via the epidural route. Nalbuphine was also added in epidural analgesia for adults and provided an increase in the efficacy and the duration of postoperative analgesia. The effect of nalbuphine addition in caudal anesthesia in pediatrics is not well established.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
No Intervention
Arm Description
children undergoing hypospadius repair given 1 ml/kg of bupivicaine 0.25 % via caudal route to achieve post operative analgesia
Arm Title
B
Arm Type
Active Comparator
Arm Description
children undergoing hypospadius repair given 1 ml/kg of bupivicaine 0.25 % plus 0.1 mg nalbuphine via caudal route to achieve post operative analgesia
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Intervention Description
Children will be randomly assigned into 2 groups of 30 patients each. They will receive caudal anesthesia using bupivacaine 0.25% 1ml/kg plus 2 ml normal saline in the control group, bupivacaine 0.25% 1ml/kg plus nalbuphine 0.1 mg/kg in 2 ml solution in the nalbuphine group.
Primary Outcome Measure Information:
Title
post operative pain measurement
Description
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale
Time Frame
24 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male children undergoing hypospadius repair, with an American Society of Anesthesiologists (ASA) physical status I. Exclusion Criteria: Guardians refusal. Contraindication to caudal block such as: Patients with congenital anomalies at the lower spine or meninges. Patients with increased intracranial pressure. Patients with skin infection at the site of injection. Patients with bleeding diathesis. Know allergy to any drug used in this study.
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
13915759
Citation
SPIEGEL P. Caudal anesthesia in pediatric surgery: a preliminary report. Anesth Analg. 1962 Mar-Apr;41:218-21. No abstract available.
Results Reference
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PubMed Identifier
12644422
Citation
de Beer DA, Thomas ML. Caudal additives in children--solutions or problems? Br J Anaesth. 2003 Apr;90(4):487-98. doi: 10.1093/bja/aeg064. No abstract available.
Results Reference
background
PubMed Identifier
6983316
Citation
Lake CL, Duckworth EN, DiFazio CA, Durbin CG, Magruder MR. Cardiovascular effects of nalbuphine in patients with coronary or valvular heart disease. Anesthesiology. 1982 Dec;57(6):498-503. doi: 10.1097/00000542-198212000-00012.
Results Reference
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Nalbuphine Plus Caudal Bupivacaine in Hypospadius Repair

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