Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Caudal nerve block /neuroaxial
Dorsal penile nerve block
Combined caudal and dorsal penile nerve block
Sponsored by

About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Age: 3-12 years.
- ASA I & II.
Exclusion Criteria:
- Patient's refusal.
- Contraindications to regional blocks as bleeding disorders and skin infections.
- Drug hypersensitivity.
- Failure of achieving block.
Sites / Locations
- Ain shams university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
dorsal penile block patients
caudal block patients
combined block patients
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
: intra-operative heart rate (beats/ minuts).
: intra-operative heart rate (beats/ minuts).
: intra-operative heart rate (beats/ minuts).
intra-operative mean arterial blood pressure (mmhg)
complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05342259
Brief Title
Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision
Official Title
Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
November 25, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
Cases were subdivided into three groups: Group 1: included dorsal penile block patients. Group 2: included caudal block patients. Group 3: included combined block patients.
Circumcision was performed under general anesthesia and dorsal slit technique was used.
Study procedure:
General anesthesia was induced and maintained by inhalation of sevoflurane in oxygen mixed with air gas flow. A 22-G intravenous (i.v.) cannula was placed after induction. Spontaneous respiration was maintained via a selected laryngeal mask airway, and the inhaled sevoflurane was modified and maintained as 0.8 to 1.0MAC.
Block techniques:
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 SCL but was associated with a miss rate up to 26% even in experienced hands. The "whoosh test," performed by auscultation at the thoracolumbar region with a stethoscope while injecting 2 mL of air, had a sensitivity of 80% and a specificity of 60% in adults. 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%. The inaccuracy of using blind technique for caudal epidural injection in adults, even confirmed by various tests, is clearly evident.
Drugs and doses used: 0.5 ml/kg of 0.25% Bupivacaine (diluted by saline solution 0.9).
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). Combined block:
The caudal block was performed then the patient was placed in supine position and the DPNB was done .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dorsal penile block patients
Arm Type
Active Comparator
Arm Title
caudal block patients
Arm Type
Active Comparator
Arm Title
combined block patients
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Caudal nerve block /neuroaxial
Intervention Description
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%.
Intervention Type
Procedure
Intervention Name(s)
Dorsal penile nerve block
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Combined caudal and dorsal penile nerve block
Intervention Description
Combined techniques of caudal and dorsal penile nerve block
Primary Outcome Measure Information:
Title
pain scoring using the Wong Baker scale
Description
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.
Time Frame
1st hour postoperatively
Title
pain scoring using the Wong Baker scale
Description
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.
Time Frame
3rd hour postoperatively
Title
pain scoring using the Wong Baker scale
Description
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.
Time Frame
24th hour postoperatively
Secondary Outcome Measure Information:
Title
: intra-operative heart rate (beats/ minuts).
Time Frame
scale at 1st hour post operative
Title
: intra-operative heart rate (beats/ minuts).
Time Frame
scale at 3rd hour post operative
Title
: intra-operative heart rate (beats/ minuts).
Time Frame
scale at 24th hour post operative
Title
intra-operative mean arterial blood pressure (mmhg)
Time Frame
intraoperatively
Title
complications
Time Frame
one day after operation
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 3-12 years.
ASA I & II.
Exclusion Criteria:
Patient's refusal.
Contraindications to regional blocks as bleeding disorders and skin infections.
Drug hypersensitivity.
Failure of achieving block.
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
20
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision
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