Pain, PostoperativeNCT05342259
Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision
A study testing Caudal nerve block /neuroaxial, Dorsal penile nerve block and Combined caudal and dorsal penile nerve block in people with Pain, Postoperative, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Caudal nerve block /neuroaxial, Dorsal penile nerve block and Combined caudal and dorsal penile nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 3-12 years.
- ASA I \& II.
Who cannot join
- Patient's refusal.
- Contraindications to regional blocks as bleeding disorders and skin infections.
- Drug hypersensitivity.
- Failure of achieving block.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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 .
- Conditions
- Pain, Postoperative
- Being tested
- Caudal nerve block /neuroaxial, Dorsal penile nerve block, Combined caudal and dorsal penile nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal nerve block /neuroaxialProcedure or surgery
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%.
Dorsal penile nerve blockProcedure or surgery
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 caudal and dorsal penile nerve blockProcedure or surgery
Combined techniques of caudal and dorsal penile nerve block
| Study group | Role | What they receive |
|---|---|---|
| dorsal penile block patients | Active comparator | Not described Receives: Procedure: Dorsal penile nerve block |
| caudal block patients | Active comparator | Not described Receives: Procedure: Caudal nerve block /neuroaxial |
| combined block patients | Active comparator | Not described Receives: Procedure: Combined caudal and dorsal penile nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24th hour postoperatively
Secondary outcomes (5)
: intra-operative heart rate (beats/ minuts).
Measured: scale at 1st hour post operative
: intra-operative heart rate (beats/ minuts).
Measured: scale at 3rd hour post operative
: intra-operative heart rate (beats/ minuts).
Measured: scale at 24th hour post operative
intra-operative mean arterial blood pressure (mmhg)
Measured: intraoperatively
complications
Measured: one day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start25 May 2022
- Primary completion25 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342259
- Sponsor's protocol ID
- FMASU MS 573/ 2021
- Status last verified
- Jan 2023
- First submitted
- 8 Mar 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision
- ClinicalTrials.gov ID
- NCT05342259
- Acronym / sponsor ID
- FMASU MS 573/ 2021
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age: 3-12 years.
- ASA I \& II.
Key exclusion criteria (4 listed)
- Patient's refusal.
- Contraindications to regional blocks as bleeding disorders and skin infections.
- Drug hypersensitivity.
- Failure of achieving block.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caudal nerve block /neuroaxialTechnique 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%. | Procedure or surgery | caudal block patients |
| Dorsal penile nerve blockTechnique 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). | Procedure or surgery | dorsal penile block patients |
| Combined caudal and dorsal penile nerve blockCombined techniques of caudal and dorsal penile nerve block | Procedure or surgery | combined block patients |
Primary outcome
pain scoring using the Wong Baker scale
Time frame: 1st hour postoperatively
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
Time frame: 3rd hour postoperatively
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
Time frame: 24th hour postoperatively
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.
5 secondary outcomes
: intra-operative heart rate (beats/ minuts).
Time frame: scale at 1st hour post operative
: intra-operative heart rate (beats/ minuts).
Time frame: scale at 3rd hour post operative
: intra-operative heart rate (beats/ minuts).
Time frame: scale at 24th hour post operative
intra-operative mean arterial blood pressure (mmhg)
Time frame: intraoperatively
complications
Time frame: one day after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal nerve block /neuroaxial, Dorsal penile nerve block and Combined caudal and dorsal penile nerve block in people with Pain, Postoperative, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain scoring using the Wong Baker scale (time frame: 1st hour postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.