Nalbuphine Plus Caudal Bupivacaine in Hypospadius Repair

NCT ID: NCT03476772

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-10-01

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

B

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

Group Type: ACTIVE_COMPARATOR

Nalbuphine

Intervention Type: DRUG

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.

Interventions

Nalbuphine

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

TKSayed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Asyut, , Egypt

Countries

Egypt

References

SPIEGEL P. Caudal anesthesia in pediatric surgery: a preliminary report. Anesth Analg. 1962 Mar-Apr;41:218-21. No abstract available.

Reference Type: BACKGROUND

PMID: 13915759 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12644422 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6983316 (View on PubMed)

Other Identifiers

NBCH

Identifier Type: -

Identifier Source: org_study_id