Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision

NCT05342259 | Completed DMC

• 1 other identifier: FMASU MS 573/ 2021
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

in order to eliminate fear and anxiety. Regional techniques are more effective than systemic opioids, non steroidal anti-inflammatory drugs, and acetaminophen for postoperative analgesia in circumcision, The most preferred techniques are dorsal penile nerve block and caudal block. Objective: To investigate the effectiveness of post operative analgesia and complications among dorsal penile nerve block, caudal block and the combination of both. Patients and Methods: Our study was carried out to compare the effectiveness, duration of post-operative analgesia, and the complications among dorsal penile nerve block (DPNB), caudal nerve block (CNB) and the combination of both. This study will carrey out on 81 male patients, aged from 3-12 years old \& undergoing circumcision. The patients were divided into 3 groups, each is composed of 27 patients; group 1 including DPNB patients, group 2 including CNB patients and group 3 for combined block. This study compared between the three groups regarding the intra-operative vital data (HR,BP), post-operative VAS scores and the complications (nausea, vomiting, urinary retention, itching, constipation \& CNS depression).

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (3)

• pain scoring using the Wong Baker scale

  scale at 1st hour post operative, that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.

  1st hour postoperatively

• pain scoring using the Wong Baker scale

  scale at 3rd hour post operative, that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.

  3rd hour postoperatively

• pain scoring using the Wong Baker scale

  scale at 24th hour post operative, that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.

  24th hour postoperatively

Secondary Outcomes (5)

• : intra-operative heart rate (beats/ minuts).

  scale at 1st hour post operative

• : intra-operative heart rate (beats/ minuts).

  scale at 3rd hour post operative

• : intra-operative heart rate (beats/ minuts).

  scale at 24th hour post operative

• intra-operative mean arterial blood pressure (mmhg)

  intraoperatively

• complications

  one day after operation

Study Arms (3)

dorsal penile block patients

ACTIVE COMPARATOR

Procedure: Dorsal penile nerve block

caudal block patients

ACTIVE COMPARATOR

Procedure: Caudal nerve block /neuroaxial

combined block patients

ACTIVE COMPARATOR

Procedure: Combined caudal and dorsal penile nerve block

Interventions

Caudal nerve block /neuroaxial PROCEDURE

Technique of the caudal block The patient was placed in lateral decubitus position for blind caudal epidural block. A line was drawn to connect the bilateral posterior superior iliac crests and used as one side of an equilateral triangle; then the location of the sacral hiatus was approximated by palpating the sacral cornua as 2 bony prominences, the sacral hiatus was identified as a dimple in between. A needle was inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone was contacted. A subjective feeling of loss of resistance suggests piercing the sacral ligament.The "whoosh test," performed by auscultation at the thoracolumbar region with a stethoscope while injecting 2 mL of air, Palpating for subcutaneous bulging on rapid injection of 5 mL air or saline had a positive predictive value of 83% and a negative predictive value of 44%.

caudal block patients

Dorsal penile nerve block PROCEDURE

Technique of Dorsal penile nerve block: Under aseptic technique and under ultrasound guidance. A 'hockey-stick' probe was used, covered by transparent sterile dressing. The probe was placed vertically over the pubic symphysis and the base of the penile shaft. With adjustment of the probe, a sagittal view of the penile shaft was produced. Scarpa's fascia was seen as a hyperechoic line superficial to the penile shaft. Under real-time guidance, the needle was inserted and advanced until its tip laid deep to Scarpa's fascia (i.e., within the subpubic space), where local anesthetic was deposited. The local anesthetic solution injected was 0.5% bupivacaine in a recommended volume. (2 ml up to 3 years and an additional 1 ml for each3 years up to maximum 6 ml).

dorsal penile block patients

Combined caudal and dorsal penile nerve block PROCEDURE

Combined techniques of caudal and dorsal penile nerve block

combined block patients

Eligibility Criteria

• Age: 3 Years - 12 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age: 3-12 years.
• ASA I \& II.

You may not qualify if:

• Patient's refusal.
• Contraindications to regional blocks as bleeding disorders and skin infections.
• Drug hypersensitivity.
• Failure of achieving block.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 20, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 22, 2022
• Study Start: May 25, 2022
• Primary Completion: November 25, 2022
• Study Completion: November 30, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)