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Comparison of the Efficacy of Clonidine-Bupivacaine versus Dexmedetomidine-Bupivacaine using Penile Block during Plastibell Circumcision: A Randomised Clinical Trial.

Comparison of the Efficacy of Clonidine-Bupivacaine versus Dexmedetomidine-Bupivacaine using Penile Block during Plastibell Circumcision: A Randomised Clinical Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202603515862961
Enrollment
80
Registered
2026-03-03
Start date
2025-01-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Interventions

Clonidine
Dexmedetomidine

Sponsors

Dr Egbuchulem Ifeanyichukwu Kelvin
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Healthy Neonates between 1 to 28 days of age, scheduled for circumcision.

Exclusion criteria

Exclusion criteria: 1. Re-do Circumcisions. 2. Neonates with genitourinary anomalies such as Hypospaedias, Epispaedias, Disorders of Sex Development, Bladder exstrophy. 3. Neonates with family history of allergy to anaesthetic drugs or who had known allergy to Bupivacaine or related drugs 4. Neonates with coagulation disorders or hematological problems such as haemorrhagic disease of the newborn. 5. Failed Plastibell circumcision necessitating the use of other methods of circumcision.

Design outcomes

Primary

MeasureTime frame
To compare the analgesic efficacy of the two groups. 1. The time to first rescue analgesia, which is the time immediately after the circumcision to the time the neonate is given an oral ibuprofen due to onset of pain. 2. The duration of sensory block which is defined as time between injection of medication via DPNB and total abolition of pinprick response to the penile shaft. The procedure will start after the block is confirmed with no sensation felt and the duration of analgesia, will be defined as the time between total abolition of pin prick response and when patients had the rescue analgesia.

Secondary

MeasureTime frame
1. The mean pain scores in the two groups will be obtained four times and recorded into a proforma by the third research assistant, 30 minutes before procedure, during adhesiolysis, at the end of procedure, and 30 minutes post circumcision. 2. The haemodynamic changes in the two groups such as heart rate, respiratory rate, oxygen saturation, temperature. The patient’s heart rate, oxygen saturation, respiratory rate and temperature will be recorded four times, 30 minutes before the start of the procedure as the base line vital sign, during adhesiolysis, at the end of the procedure marked by the detachment of plastic handle after excision of the prepuce, and 30 minutes after the procedure. 3. Any other perioperative adverse effect of the circumcision related to both drugs upto 48 hours post procedure.

Countries

Nigeria

Contacts

Public ContactTaiwo Lawal

Dean of Faculty of Clinical Sciences University of Ibadan

taiwo.lawal@hotmail.com+2348069614811

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026