AnalgesiaNCT07602894
Analgesia for Perineal Surgeries in High-risk Pediatric Patients
A study testing Systemic analgesia and Sacral multifidus plane block in people with Analgesia, run by Zagazig University at 1 site in Egypt.
Trial summary
Perioperative pain management in pediatric patients, especially for anorectal and penile surgeries, presents significant challenges for anesthetists. Complications associated with systemic analgesia, such as respiratory issues, cardiovascular problems, and neurological effects, can be avoided by using regional… Read more about this study
- Who is it for?
- Ages 12 months to 12 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Systemic analgesia and Sacral multifidus plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents or caregivers' acceptance.
- High-risk pediatric patients (the American Society of Anesthesiologists physical status class III-IV)
- Body mass index equal to 5%: 85% of the same age and sex.
Who cannot join
- Child with a contraindication to the regional block, such as infection at the site of injection, or coagulopathy.
- Pre-existing neurological disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amira Attia Ebrahim Farag, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Zagazig university hospital
Zagazig
Mohamed mohamed, MD, mgmelsayed@medicine.zu.edu.eg
About this study
Official title: Efficacy of Ultrasound-guided Sacral Multifidus Plane Block as Perioperative Analgesia for Anal and Penile Surgeries in High-risk Pediatric Patients
Perioperative pain management in pediatric patients, especially for anorectal and penile surgeries, presents significant challenges for anesthetists. Complications associated with systemic analgesia, such as respiratory issues, cardiovascular problems, and neurological effects, can be avoided by using regional anesthesia. This study aims to evaluate the effectiveness of Ultrasound-Guided Sacral Multifidus Plane Block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia.
Read the detailed description
Effective postoperative pain control in pediatric patients remains a major concern, particularly in those undergoing anal, perineal and penile surgeries. Inadequate analgesia is associated with delayed recovery, increased stress response, prolonged hospitalisation, and higher postoperative morbidity. This study aims to evaluate the efficacy of ultrasound-guided sacral multifidus plane block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia. This involves the administration of local anesthetics in the plane between the sacral multifidus muscle and the intermediate sacral crest bilaterally.
- Conditions
- Analgesia
- Being tested
- Systemic analgesia, Sacral multifidus plane block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic analgesiaOther
Patients will receive 10 milligrams per kilogram body weight of intravenous paracetamol every 8 hours and fentanyl 1 microgram per kilogram body weight intravenously as rescue analgesia.
Sacral multifidus plane blockProcedure or surgery
Patients will receive an ultrasound-guided sacral multifidus plane block after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Sacral Multifidus plane block group | Active comparator | The patients will receive an ultrasound-guided sacral multifidus plane block after induction of general anesthesia. Receives: Procedure: Sacral multifidus plane block |
| Control group | Placebo comparator | The patients will receive systemic parenteral analgesia. Receives: Other: Systemic analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to rescue analgesia
First time of additional analgesia given when the child exhibit moderate to severe pain with pain score become ≥ 4.
Measured: 24 hours
Secondary outcomes (5)
Heart rate
The perioperative changes in heart rate basally and at time interval 10-minutes till discharge and at ward at 2,4,8,16, and 24 hours postoperative.
Measured: 24 hours
Mean arterial pressure
The perioperative changes in mean blood pressure basally and at time interval 10-minutes till discharge and at ward at 2,4,8,16, and 24 hours postoperative.
Measured: 24 hours
Postoperative pain score
Pain score will be assessed using the Face, Legs, Activity, Cry, and Consolability score immediately postoperative then at 2, 4, 8, 16 and 24 hours with a score of 0 indicates no pain and 10 indicates maximum pain.
Measured: 24 hours
Total dose of opioid consumption
The total dose of opioid consumption as rescue analgesia in the first 24 hours postoperative.
Measured: 24 hours
Parental satisfaction
Parental satisfaction will be evaluated using a five-point score at the end of the first 24 hours with a score of 5 indicate the highest satisfaction and 1 indicate the lowest satisfaction.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start20 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Abdelrazek yousef, MD, Principal investigator, Department of Pediatric surgery, Zagazig UniversityMohamed Ismail Sabry, MD, Principal investigator, Department of Pediatric surgery, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602894
- Sponsor's protocol ID
- High risk pediatric analgesia
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mistry T, Sonawane K, Balasubramanian S, Balavenkatasubramanian J, Goel VK. Ultrasound-guided sacral multifidus plane block for sacral spine surgery: A case report. Saudi J Anaesth. 2022 Apr-Jun;16(2):236-239. doi: 10.4103/sja.sja_723_21. Epub 2022 Mar 17.
PubMed 35431750Stamer UM, Bernhart K, Lehmann T, Setzer M, Stuber F, Komann M, Meissner W. 'Desire for more analgesic treatment': pain and patient-reported outcome after paediatric tonsillectomy and appendectomy. Br J Anaesth. 2021 Jun;126(6):1182-1191. doi: 10.1016/j.bja.2020.12.047. Epub 2021 Mar 5.
PubMed 33685632
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-guided Sacral Multifidus Plane Block as Perioperative Analgesia for Anal and Penile Surgeries in High-risk Pediatric Patients
- ClinicalTrials.gov ID
- NCT07602894
- Acronym / sponsor ID
- High risk pediatric analgesia
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 May 2026 (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.
Perioperative pain management in pediatric patients, especially for anorectal and penile surgeries, presents significant challenges for anesthetists. Complications associated with systemic analgesia, such as respiratory issues, cardiovascular problems, and neurological effects, can be avoided by using regional anesthesia. This study aims to evaluate the effectiveness of Ultrasound-Guided Sacral Multifidus Plane Block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia.
Detailed description
Effective postoperative pain control in pediatric patients remains a major concern, particularly in those undergoing anal, perineal and penile surgeries. Inadequate analgesia is associated with delayed recovery, increased stress response, prolonged hospitalisation, and higher postoperative morbidity. This study aims to evaluate the efficacy of ultrasound-guided sacral multifidus plane block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia. This involves the administration of local anesthetics in the plane between the sacral multifidus muscle and the intermediate sacral crest bilaterally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacral Multifidus plane block group | Active comparator | Procedure: Sacral multifidus plane blockThe patients will receive an ultrasound-guided sacral multifidus plane block after induction of general anesthesia. |
| Control group | Placebo comparator | Other: Systemic analgesiaThe patients will receive systemic parenteral analgesia. |
Who may qualify
- Ages
- 12 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents or caregivers' acceptance.
- High-risk pediatric patients (the American Society of Anesthesiologists physical status class III-IV)
- Body mass index equal to 5%: 85% of the same age and sex.
Key exclusion criteria (2 listed)
- Child with a contraindication to the regional block, such as infection at the site of injection, or coagulopathy.
- Pre-existing neurological disorders.
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 |
|---|---|---|
| Systemic analgesiaPatients will receive 10 milligrams per kilogram body weight of intravenous paracetamol every 8 hours and fentanyl 1 microgram per kilogram body weight intravenously as rescue analgesia. | Other | Control group |
| Sacral multifidus plane blockPatients will receive an ultrasound-guided sacral multifidus plane block after induction of general anesthesia. | Procedure or surgery | Sacral Multifidus plane block group |
Primary outcome
Time to rescue analgesia
Time frame: 24 hours
First time of additional analgesia given when the child exhibit moderate to severe pain with pain score become ≥ 4.
5 secondary outcomes
Heart rate
Time frame: 24 hours
Mean arterial pressure
Time frame: 24 hours
Postoperative pain score
Time frame: 24 hours
Total dose of opioid consumption
Time frame: 24 hours
Parental satisfaction
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 35431750Mistry T, Sonawane K, Balasubramanian S, Balavenkatasubramanian J, Goel VK. Ultrasound-guided sacral multifidus plane block for sacral spine surgery: A case report. Saudi J Anaesth. 2022 Apr-Jun;16(2):236-239. doi: 10.4103/sja.sja_723_21. Epub 2022 Mar 17.
- Background: PubMed 33685632Stamer UM, Bernhart K, Lehmann T, Setzer M, Stuber F, Komann M, Meissner W. 'Desire for more analgesic treatment': pain and patient-reported outcome after paediatric tonsillectomy and appendectomy. Br J Anaesth. 2021 Jun;126(6):1182-1191. doi: 10.1016/j.bja.2020.12.047. Epub 2021 Mar 5.
Related trials for Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
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.
Amira Attia Ebrahim Farag, MD contact
Abdelrazek yousef, MD principal investigator
Department of Pediatric surgery, Zagazig University
Mohamed Ismail Sabry, MD principal investigator
Department of Pediatric surgery, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic analgesia and Sacral multifidus plane block in people with Analgesia, run by Zagazig 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdalla Mohamed Goda Mohamed, MD (1114166085 ext. +20, drabdogoda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to rescue analgesia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07602894, which also lists 2 linked publications.
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 24 Aug 2026.