Sacral Erector Spinae, Penile And Caudal Block For Pain Relief After Hypospadius SurgeryNCT05307653
Sacral Erector Spinae,Penile and Caudal Block for Pain Relief After Hypospadias Surgery
A study testing Penile block, Erector spinea plain block and Caudal block in people with Sacral Erector Spinae, Penile And Caudal Block For Pain Relief After Hypospadius Surgery, run by Tanta University at 1 site in Egypt.
Trial summary
Caudal anaesthesia is recommended for most surgical procedures of the lower part of the body, mainly below the umbilicus, including inguinal hernia repair, urinary and digestive tract surgery and orthopaedic procedures on the pelvic girdle and lower extremities. Read more about this study
- Who is it for?
- Ages 1 year to 5 years, men only
- Conditions the study is for
- Sacral Erector Spinae, Penile And Caudal Block For Pain Relief After Hypospadius Surgery
- What is being tested?
- Penile block, Erector spinea plain block and Caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2022to 30 Aug 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 1 year to 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Inclusion criteria was patients with distal penile, subcoronal and coronal type of hypospadias, scheduled for repair with an intermittent non-dribbling urethral stent for 7 days or less.
Who cannot join
- Bleeding diathesis
- Known allergy to local anesthesia medications
- Active infection at the injection area
- History of developmental delay
- Mental retardation (due to difficult pain assessment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Effect Of Sacral Erector Spinae, Penile And Caudal Block For Pain Relief After Hypospadius Surgery: Randomized Controlled Study
Caudal anaesthesia is recommended for most surgical procedures of the lower part of the body, mainly below the umbilicus, including inguinal hernia repair, urinary and digestive tract surgery and orthopaedic procedures on the pelvic girdle and lower extremities.
It has been well established that a dorsal penile nerve block immediately after surgery decreases postoperative pain in children undergoing hypospadias repair. For decades, penile block was widely and effectively used for various types of penile reconstructive surgery.
Read more
Recently, due to improved composition, dosage and concentration of local anaesthetics and low incidence of negative side effects, such as motor blockade and postoperative nausea and vomiting, caudal anaesthesia has become one of the most used and accepted regional blocks for children undergoing hypospadias repair.
However, postoperative patient comfort is a major issue after distal hypospadias repair and depends on adequate analgesia and unimpaired micturition, especially when no suprapubic catheter is in place. Micturition impairment and urinary retention is a known side effect of caudal block anaesthesia.
The comparison of penile block and caudal block has not been described in the literature to our knowledge.
Use of ESPB for different indications from different levels has become the new trend of regional anesthesia practice from the moment it was first defined . There have been many reports for its use in thoracic and lumbar levels.
This great interest probably depends on its effectiveness as well as the ease of the block technique: injecting the local anesthetic deep to the erector spinae muscle (ESM) above the transverse process. With this report, we would like to identify a modification to sacral ESPB with our longitudinal midline approach with the presentation of a case of an infant who was scheduled for hypospadias repair.
Read the detailed description
Patients will be randomly divided into three groups by using a computer-generated randomization. Sealed opaque envelopes containing group allocation will be before the blocks will be performed. Then, each patient will be asked to choose one of the envelopes and give to an anesthesiologist who will compare it to the computer-generated list and hence assignee her to one of the three groups. Anesthesiologist (who will be blinded to the collected data until the end of the study) will perform the block techniques and administer the medication.
- Group C (Caudal group) n=44: after prep and drep, in left lateral position caudal block will be performed with bupivacaine 0.25%, 1 ml/kg (max 20 ml).
- Group P (Penile block) n=44: after prep and drep in supine position, the penis will be retracted downward and fixed with leucoplast. The markers for injection will be, symphysis pubis, 0.5 to 1 cm lateral to the midline, the needle will be inserted vertically (medially-caudally) until penetrating fascia scarpa and bupivacaine 0.5%, 0.1 ml/kg (max 2.5 ml), will be injected in each side. Blocks will be performed with 22-G needles and skin incision will be performed 20 minutes after block in each group.
- Group E (Erector spinea plain block group) n=44:
Before the start of surgery, patient will be turned to prone position for block application. Following cleansing of the block area, linear ultrasound probe (Esaote My Lab 6 US machine, Florence, Italy) will be placed longitudinally to midline just above the sacrum . Median sacral crests and erector spinae muscle will be identified.
A 22G, 50mm needle (B. Braun Melsungen, Germany) will be inserted from the edge of the probe using in-plane technique. Needle will be advanced with a cranial to caudal direction until its tip touched to the top of the 4th median sacral crest. Following negative aspiration, 8 mL of 0, 25% Bupivacaine (with a dose of 1 mL/kg) will be injected for the block application. Then the patient will be turned to supine position and surgery started.
Anesthesia Protocol All the patients will be adequately assessed preoperatively in the anesthesia clinic through history taking, general and local examination, and requesting investigation. Adequate explanation of the procedure, benefit, and potential hazards will be done to the parents with final reassurance of them. All children will receive sedation in the form of oral midazolam 0.05 mg/kg 15 minutes before admission to the operating room.
Upon admission to the operating room, intravascular access will be obtained with starting i.v infusion of Dextrose 5% in normal saline (7 ml/kg). Then, the patients will be attached to a monitor of pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide, temperature, and 5 leads electrocardiogram. Induction of anesthesia will be carried out using sevoflurane 6% in oxygen: air (4:1) till the child loss the consciousness, then, fentanyl 0.5 ug/kg will be given intravenously and atracurium 1 ug/kg will be given intravenously to facilitate endotracheal intubation. A suitable sized endotracheal tube will be introduced and secured with connection of the patients to a mechanical ventilator (pressure-controlled mode) which parameters will be adjusted to maintain end-tidal carbon dioxide 36-40 mmHg.
Anesthesia will be maintained by sevoflurane (1 MAC) with incremental doses of atracurium. Also, incremental doses of fentanyl 0.5 ug/kg will be given i.v in case of increase bispectral index (BIS) more than 60 or by increase in the heart rate or the mean arterial pressure by more than 20% of the baseline values.
At the end of the surgery, the sevoflurane will be switched off with reversal of the muscle relaxation by combination of neostigmine 0.04 mg/kg and atropine 0.01 mg/kg. Awake extubation will be then performed with transporting the child to the recovery room for adequate postoperative monitoring. All the children will receive paracetamol 15 mg/kg i.v infusion every 6 h. The children will be discharged from the recovery room when their modified Aldrete's score reach 10.
Postoperatively, patient was evaluated with Face, Leg, Activity, Cry, Consolability Revised (FLACC-R) score for pain management and it was 0 or 1 for entire postoperative 24 h. In recovery or ward, rectal acetaminophen was administered for an age-appropriate pain score between 3 and 5 (0-10) and intravenous meperidine 1 mg/kg for an age-appropriate pain score of >5 (0-10).
Measurements The following parameters will be recorded by an anesthesia resident not included in the study and blinded to its groups: -
- Demographic data (Age in month, body weight, and ASA class)
- Total consumption of pethidine (mg/kg) in first day postoperatively. (secondary outcome)
- The duration of postoperative analgesia which defied as: The time (in hours)from the beginning of the block to the first rescue analgesia request (primary outcome)
- The postoperative pain score (FLAC pain score) every 2 hours in the first 8 hours then every 4 hours till 24 h. (Secondary outcome)
- The total dose of fentanyl consumed intraoperatively.
- The incidence of perioperative complications including bradycardia, hypotension, nausea and vomiting, localized hematoma, infection, or pruritis.
- Being tested
- Penile block, Erector spinea plain block, Caudal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile blockProcedure or surgery
Penile block was performed in supine position. The penis was retracted caudally and then fixed with a leucoplast. After identifying the symphysis pubis (SP), a 22-gauge needle was inserted vertically about 1 cm lateral to the SP, and bupivacaine 0.5% (0.1 ml/kg, maximum 2.5 ml) was injected on each side after penetrating the Scarpa's fascia.
Erector spinea plain blockProcedure or surgery
Ultrasound guided ESPB was performed in prone position by Philips © (CX50 Extreme edition). The superficial probe was placed longitudinally at the midline just above the sacrum, and both erector spinae muscles and median sacral crests were identified. Using the in-plane approach, a 22-gauge needle was inserted in a craniocaudal direction till reaching the tip of the fourth median sacral crest. After negative aspiration to avoid intravascular or intrathecal puncture, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered.
Caudal blockProcedure or surgery
Caudal block was performed in the left lateral position. A 22 G needle was inserted through the sacral hiatus. The loss of resistance method was used to pass through the sacrococcygeal membrane and enter the caudal epidural space. Negative aspiration was then performed. When no blood or cerebrospinal fluid was observed, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered. The patient was returned to the supine position after the procedure was completed.
| Study group | Role | What they receive |
|---|---|---|
| Penile block | Experimental | Penile block was performed in supine position. The penis was retracted caudally and then fixed with a leucoplast. After identifying the symphysis pubis (SP), a 22-gauge needle was inserted vertically about 1 cm lateral to the SP, and bupivacaine 0.5% (0.1 ml/kg, maximum 2.5 ml) was injected on each side after penetrating the Scarpa's fascia. Receives: Procedure: Penile block |
| Erector spinea plain block group | Experimental | Ultrasound guided ESPB was performed in prone position by Philips © (CX50 Extreme edition). The superficial probe was placed longitudinally at the midline just above the sacrum, and both erector spinae muscles and median sacral crests were identified. Using the in-plane approach, a 22-gauge needle was inserted in a craniocaudal direction till reaching the tip of the fourth median sacral crest. After negative aspiration to avoid intravascular or intrathecal puncture, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered. Receives: Procedure: Erector spinea plain block |
| Caudal group | Experimental | Caudal block was performed in the left lateral position. A 22 G needle was inserted through the sacral hiatus. The loss of resistance method was used to pass through the sacrococcygeal membrane and enter the caudal epidural space. Negative aspiration was then performed. When no blood or cerebrospinal fluid was observed, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered. The patient was returned to the supine position after the procedure was completed. Receives: Procedure: Caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first analgesic request
The time (in hours) from the beginning of the block to the first rescue analgesia request was recorded
Measured: 24 hours postoperative
Secondary outcomes (4)
Face, Legs, Activity, Cry, and Consolability (FLACC) Score
FLACC scale will be used to assess pain for children between the ages 2 months and 7 years or individuals that unable to communicate their pain. The scale is scored of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1or 2. FLACC scale will be recorded every 2 hours in the first 8 hours then every 4 hours till 24 h. (Secondary outcome)
Measured: 24 hours Postoperative
The total amount of analgesia
Total consumption of pethidine (mg/kg) in the first day postoperatively
Measured: 24 hours Postoperative
The incidence of perioperative complications.
The incidence of perioperative complications including bradycardia, hypotension, nausea and vomiting, localized hematoma, infection, or pruritis was recorded.
Measured: 24 hour postoperatively
Penile engorgement
The occurence of penile engorgement.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start15 Apr 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacral Erector Spinae, Penile And Caudal Block For Pain Relief After Hypospadius SurgeryStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Arafa Elbadry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307653
- Sponsor's protocol ID
- Pain Relief After Hypospadius
- Status last verified
- Aug 2022
- First submitted
- 23 Mar 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect Of Sacral Erector Spinae, Penile And Caudal Block For Pain Relief After Hypospadius Surgery: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05307653
- Acronym / sponsor ID
- Pain Relief After Hypospadius
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 1 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.
Caudal anaesthesia is recommended for most surgical procedures of the lower part of the body, mainly below the umbilicus, including inguinal hernia repair, urinary and digestive tract surgery and orthopaedic procedures on the pelvic girdle and lower extremities.
It has been well established that a dorsal penile nerve block immediately after surgery decreases postoperative pain in children undergoing hypospadias repair. For decades, penile block was widely and effectively used for various types of penile reconstructive surgery.
Recently, due to improved composition, dosage and concentration of local anaesthetics and low incidence of negative side effects, such as motor blockade and postoperative nausea and vomiting, caudal anaesthesia has become one of the most used and accepted regional blocks for children undergoing hypospadias repair.
However, postoperative patient comfort is a major issue after distal hypospadias repair and depends on adequate analgesia and unimpaired micturition, especially when no suprapubic catheter is in place. Micturition impairment and urinary retention is a known side effect of caudal block anaesthesia.
The comparison of penile block and caudal block has not been described in the literature to our knowledge.
Use of ESPB for different indications from different levels has become the new trend of regional anesthesia practice from the moment it was first defined . There have been many reports for its use in thoracic and lumbar levels.
This great interest probably depends on its effectiveness as well as the ease of the block technique: injecting the local anesthetic deep to the erector spinae muscle (ESM) above the transverse process. With this report, we would like to identify a modification to sacral ESPB with our longitudinal midline approach with the presentation of a case of an infant who was scheduled for hypospadias repair.
Detailed description
Patients will be randomly divided into three groups by using a computer-generated randomization. Sealed opaque envelopes containing group allocation will be before the blocks will be performed. Then, each patient will be asked to choose one of the envelopes and give to an anesthesiologist who will compare it to the computer-generated list and hence assignee her to one of the three groups. Anesthesiologist (who will be blinded to the collected data until the end of the study) will perform the block techniques and administer the medication.
- Group C (Caudal group) n=44: after prep and drep, in left lateral position caudal block will be performed with bupivacaine 0.25%, 1 ml/kg (max 20 ml).
- Group P (Penile block) n=44: after prep and drep in supine position, the penis will be retracted downward and fixed with leucoplast. The markers for injection will be, symphysis pubis, 0.5 to 1 cm lateral to the midline, the needle will be inserted vertically (medially-caudally) until penetrating fascia scarpa and bupivacaine 0.5%, 0.1 ml/kg (max 2.5 ml), will be injected in each side. Blocks will be performed with 22-G needles and skin incision will be performed 20 minutes after block in each group.
- Group E (Erector spinea plain block group) n=44:
Before the start of surgery, patient will be turned to prone position for block application. Following cleansing of the block area, linear ultrasound probe (Esaote My Lab 6 US machine, Florence, Italy) will be placed longitudinally to midline just above the sacrum . Median sacral crests and erector spinae muscle will be identified.
A 22G, 50mm needle (B. Braun Melsungen, Germany) will be inserted from the edge of the probe using in-plane technique. Needle will be advanced with a cranial to caudal direction until its tip touched to the top of the 4th median sacral crest. Following negative aspiration, 8 mL of 0, 25% Bupivacaine (with a dose of 1 mL/kg) will be injected for the block application. Then the patient will be turned to supine position and surgery started.
Anesthesia Protocol All the patients will be adequately assessed preoperatively in the anesthesia clinic through history taking, general and local examination, and requesting investigation. Adequate explanation of the procedure, benefit, and potential hazards will be done to the parents with final reassurance of them. All children will receive sedation in the form of oral midazolam 0.05 mg/kg 15 minutes before admission to the operating room.
Upon admission to the operating room, intravascular access will be obtained with starting i.v infusion of Dextrose 5% in normal saline (7 ml/kg). Then, the patients will be attached to a monitor of pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide, temperature, and 5 leads electrocardiogram. Induction of anesthesia will be carried out using sevoflurane 6% in oxygen: air (4:1) till the child loss the consciousness, then, fentanyl 0.5 ug/kg will be given intravenously and atracurium 1 ug/kg will be given intravenously to facilitate endotracheal intubation. A suitable sized endotracheal tube will be introduced and secured with connection of the patients to a mechanical ventilator (pressure-controlled mode) which parameters will be adjusted to maintain end-tidal carbon dioxide 36-40 mmHg.
Anesthesia will be maintained by sevoflurane (1 MAC) with incremental doses of atracurium. Also, incremental doses of fentanyl 0.5 ug/kg will be given i.v in case of increase bispectral index (BIS) more than 60 or by increase in the heart rate or the mean arterial pressure by more than 20% of the baseline values.
At the end of the surgery, the sevoflurane will be switched off with reversal of the muscle relaxation by combination of neostigmine 0.04 mg/kg and atropine 0.01 mg/kg. Awake extubation will be then performed with transporting the child to the recovery room for adequate postoperative monitoring. All the children will receive paracetamol 15 mg/kg i.v infusion every 6 h. The children will be discharged from the recovery room when their modified Aldrete's score reach 10.
Postoperatively, patient was evaluated with Face, Leg, Activity, Cry, Consolability Revised (FLACC-R) score for pain management and it was 0 or 1 for entire postoperative 24 h. In recovery or ward, rectal acetaminophen was administered for an age-appropriate pain score between 3 and 5 (0-10) and intravenous meperidine 1 mg/kg for an age-appropriate pain score of >5 (0-10).
Measurements The following parameters will be recorded by an anesthesia resident not included in the study and blinded to its groups: -
- Demographic data (Age in month, body weight, and ASA class)
- Total consumption of pethidine (mg/kg) in first day postoperatively. (secondary outcome)
- The duration of postoperative analgesia which defied as: The time (in hours)from the beginning of the block to the first rescue analgesia request (primary outcome)
- The postoperative pain score (FLAC pain score) every 2 hours in the first 8 hours then every 4 hours till 24 h. (Secondary outcome)
- The total dose of fentanyl consumed intraoperatively.
- The incidence of perioperative complications including bradycardia, hypotension, nausea and vomiting, localized hematoma, infection, or pruritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Penile block | Experimental | Procedure: Penile blockPenile block was performed in supine position. The penis was retracted caudally and then fixed with a leucoplast. After identifying the symphysis pubis (SP), a 22-gauge needle was inserted vertically about 1 cm lateral to the SP, and bupivacaine 0.5% (0.1 ml/kg, maximum 2.5 ml) was injected on each side after penetrating the Scarpa's fascia. |
| Erector spinea plain block group | Experimental | Procedure: Erector spinea plain blockUltrasound guided ESPB was performed in prone position by Philips © (CX50 Extreme edition). The superficial probe was placed longitudinally at the midline just above the sacrum, and both erector spinae muscles and median sacral crests were identified. Using the in-plane approach, a 22-gauge needle was inserted in a craniocaudal direction till reaching the tip of the fourth median sacral crest. After negative aspiration to avoid intravascular or intrathecal puncture, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered. |
| Caudal group | Experimental | Procedure: Caudal blockCaudal block was performed in the left lateral position. A 22 G needle was inserted through the sacral hiatus. The loss of resistance method was used to pass through the sacrococcygeal membrane and enter the caudal epidural space. Negative aspiration was then performed. When no blood or cerebrospinal fluid was observed, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered. The patient was returned to the supine position after the procedure was completed. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inclusion criteria was patients with distal penile, subcoronal and coronal type of hypospadias, scheduled for repair with an intermittent non-dribbling urethral stent for 7 days or less.
Key exclusion criteria (5 listed)
- Bleeding diathesis
- Known allergy to local anesthesia medications
- Active infection at the injection area
- History of developmental delay
- Mental retardation (due to difficult pain assessment).
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 |
|---|---|---|
| Penile blockPenile block was performed in supine position. The penis was retracted caudally and then fixed with a leucoplast. After identifying the symphysis pubis (SP), a 22-gauge needle was inserted vertically about 1 cm lateral to the SP, and bupivacaine 0.5% (0.1 ml/kg, maximum 2.5 ml) was injected on each side after penetrating the Scarpa's fascia. | Procedure or surgery | Penile block |
| Erector spinea plain blockUltrasound guided ESPB was performed in prone position by Philips © (CX50 Extreme edition). The superficial probe was placed longitudinally at the midline just above the sacrum, and both erector spinae muscles and median sacral crests were identified. Using the in-plane approach, a 22-gauge needle was inserted in a craniocaudal direction till reaching the tip of the fourth median sacral crest. After negative aspiration to avoid intravascular or intrathecal puncture, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered. | Procedure or surgery | Erector spinea plain block group |
| Caudal blockCaudal block was performed in the left lateral position. A 22 G needle was inserted through the sacral hiatus. The loss of resistance method was used to pass through the sacrococcygeal membrane and enter the caudal epidural space. Negative aspiration was then performed. When no blood or cerebrospinal fluid was observed, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered. The patient was returned to the supine position after the procedure was completed. | Procedure or surgery | Caudal group |
Primary outcome
Time to the first analgesic request
Time frame: 24 hours postoperative
The time (in hours) from the beginning of the block to the first rescue analgesia request was recorded
4 secondary outcomes
Face, Legs, Activity, Cry, and Consolability (FLACC) Score
Time frame: 24 hours Postoperative
The total amount of analgesia
Time frame: 24 hours Postoperative
The incidence of perioperative complications.
Time frame: 24 hour postoperatively
Penile engorgement
Time frame: Intraoperatively
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 2 Sep 2022.
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 Penile block, Erector spinea plain block and Caudal block in people with Sacral Erector Spinae, Penile And Caudal Block For Pain Relief After Hypospadius Surgery, run by Tanta 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 1 inclusion and 5 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 2 Sep 2022. 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?
Time to the first analgesic request (time frame: 24 hours postoperative). 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 2 Sep 2022.