Post Operative PainNCT05580094
Combined Supraclavicular Block and General Anesthesia in Pediatric Patients With Chronic Kidney Disease
A study testing general anesthesia only. and general anesthesia plus supraclavicular block. in people with Post Operative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
compare the safety and efficacy of ultrasound-guided supraclavicular block in addition to general anesthesia in pediatric patients undergoing upper limb superficialization of arteriovenous fistula for hemodialysis. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- general anesthesia only. and general anesthesia plus supraclavicular block.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Nov 2022to 10 Jan 2024
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients of less than 18 years old.
- with chronic kidney disease.
- undergoing upper limb superficialization of arteriovenous fistula for haemodialysis.
Who cannot join
- Patient known to have allergy to the studied drugs.
- Patients with contraindications to regional anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined General Anesthesia and Ultrasound Guided Supraclavicular Block Versus General Anesthesia in Pediatric Patients With Chronic Kidney Disease Undergoing Upper Limb Superficialization of Arteriovenous Fistula.
- compare the safety and efficacy of ultrasound-guided supraclavicular block in addition to general anesthesia in pediatric patients undergoing upper limb superficialization of arteriovenous fistula for hemodialysis.
- compare the amount of analgesic consumption as well as vasodilatation of upper limb blood vessels and its implications on the vascular anastomosis.
Read the detailed description
Established renal disease is a significant cause of morbidity and mortality in children and has implications for the conduct of general anesthesia (1).
Anesthetic management of pediatric patients is uniquely challenging. A large part of the anesthetic care includes pain management, management of concomitant disease, and risk reduction for adverse events. Perioperative pain management usually involves a multimodal pharmacologic approach to minimize opioid requirements. Regional anesthesia is valuable for postoperative pain control (2).
Postoperative analgesia is dictated by the extent and nature of the surgery. Regional block should be utilized where possible for its opioid-sparing effects. Where morphine infusions are commenced, the dose should be reduced due to the risk of accumulation of active metabolites and resultant opiate toxicity. Non-steroidal anti-inflammatory drugs are always avoided due to their deleterious effects on urine output (3).
Pediatric regional anesthesia is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anesthetic practice. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids. Upper extremity brachial plexus blocks in children Various approaches to brachial plexus are available. The choice of the block is made depending on the indications. The supra-clavicular approach covers all the surgeries of the humerus and below (4).
The use of regional anaesthesia is mostly associated with vasodilatation which may guard against arterial spasm and may play a role in decreasing the postoperative complication and success of the superficialization of the arteriovenous shunt as a line for hemodialysis.
- Conditions
- Post Operative Pain
- Being tested
- general anesthesia only., general anesthesia plus supraclavicular 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.
general anesthesia only.Other
induction of general anesthesia by propofol and maintenance sevoflurane.
general anesthesia plus supraclavicular block.Other
induction of general anesthesia by propofol and maintenance sevoflurane then the patients will receive the supraclavicular block with bupivacaine 0.5 ml per kg.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia only. | Placebo comparator | the pediatric patients will receive general anesthesia only. Receives: Other: general anesthesia only. |
| General anesthesia plus supraclavicular block. | Active comparator | the pediatric patients will receive combined supraclavicular block and general anesthesia. Receives: Other: general anesthesia plus supraclavicular block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
brachiocephalic fistula maturation time
time in weeks required by fistula to be clinically mature
Measured: 6 month postoperative
Secondary outcomes (4)
anaesthetic consumption
measurment of anesthesia MAC
Measured: 90 minutes intraoperative
postoperative analgesia time
Measured: 24 hours postoperative
EMERGENCE agitation
RASS score used with -5 = deeply sedated and 4 = highly agitated
Measured: 30 minutes postoperative
VAS score
scale of 10 points. zero= no pain and 10 = worest pain
Measured: 24h postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start14 Nov 2022
- Primary completion10 Jul 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Model description
- Randomized, double-blinded controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Fathy Radwan Abd Elzaher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580094
- Sponsor's protocol ID
- supraclavicular block and GA
- Status last verified
- Nov 2024
- First submitted
- 6 Oct 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
PubMed 26171895Suresh S, Schaldenbrand K, Wallis B, De Oliveira GS Jr. Regional anaesthesia to improve pain outcomes in paediatric surgical patients: a qualitative systematic review of randomized controlled trials. Br J Anaesth. 2014 Sep;113(3):375-90. doi: 10.1093/bja/aeu156. Epub 2014 Jun 6.
PubMed 24907283De Jose Maria B, Banus E, Navarro Egea M, Serrano S, Perello M, Mabrok M. Ultrasound-guided supraclavicular vs infraclavicular brachial plexus blocks in children. Paediatr Anaesth. 2008 Sep;18(9):838-44. doi: 10.1111/j.1460-9592.2008.02644.x. Epub 2008 Jun 9.
PubMed 18544144Elsawy S, Fathy E, Elbadawy A, Elnaggar A, Abdelatif AF, Elmorabaa H, Hamed R. Ultrasound-guided supraclavicular brachial plexus block as an additive to sevoflurane anesthesia in pediatrics undergoing brachiobasilic arteriovenous fistula operation: randomized controlled clinical trial. BMC Anesthesiol. 2025 May 16;25(1):248. doi: 10.1186/s12871-025-03091-1.
PubMed 40380096
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined General Anesthesia and Ultrasound Guided Supraclavicular Block Versus General Anesthesia in Pediatric Patients With Chronic Kidney Disease Undergoing Upper Limb Superficialization of Arteriovenous Fistula.
- ClinicalTrials.gov ID
- NCT05580094
- Acronym / sponsor ID
- supraclavicular block and GA
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 14 Oct 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.
- compare the safety and efficacy of ultrasound-guided supraclavicular block in addition to general anesthesia in pediatric patients undergoing upper limb superficialization of arteriovenous fistula for hemodialysis.
- compare the amount of analgesic consumption as well as vasodilatation of upper limb blood vessels and its implications on the vascular anastomosis.
Detailed description
Established renal disease is a significant cause of morbidity and mortality in children and has implications for the conduct of general anesthesia (1).
Anesthetic management of pediatric patients is uniquely challenging. A large part of the anesthetic care includes pain management, management of concomitant disease, and risk reduction for adverse events. Perioperative pain management usually involves a multimodal pharmacologic approach to minimize opioid requirements. Regional anesthesia is valuable for postoperative pain control (2).
Postoperative analgesia is dictated by the extent and nature of the surgery. Regional block should be utilized where possible for its opioid-sparing effects. Where morphine infusions are commenced, the dose should be reduced due to the risk of accumulation of active metabolites and resultant opiate toxicity. Non-steroidal anti-inflammatory drugs are always avoided due to their deleterious effects on urine output (3).
Pediatric regional anesthesia is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anesthetic practice. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids. Upper extremity brachial plexus blocks in children Various approaches to brachial plexus are available. The choice of the block is made depending on the indications. The supra-clavicular approach covers all the surgeries of the humerus and below (4).
The use of regional anaesthesia is mostly associated with vasodilatation which may guard against arterial spasm and may play a role in decreasing the postoperative complication and success of the superficialization of the arteriovenous shunt as a line for hemodialysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded controlled trial.
| Arm | Type | Receives |
|---|---|---|
| General anesthesia only. | Placebo comparator | Other: general anesthesia only.the pediatric patients will receive general anesthesia only. |
| General anesthesia plus supraclavicular block. | Active comparator | Other: general anesthesia plus supraclavicular block.the pediatric patients will receive combined supraclavicular block and general anesthesia. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric patients of less than 18 years old.
- with chronic kidney disease.
- undergoing upper limb superficialization of arteriovenous fistula for haemodialysis.
Key exclusion criteria (2 listed)
- Patient known to have allergy to the studied drugs.
- Patients with contraindications to regional anesthesia.
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 |
|---|---|---|
| general anesthesia only.induction of general anesthesia by propofol and maintenance sevoflurane. | Other | General anesthesia only. |
| general anesthesia plus supraclavicular block.induction of general anesthesia by propofol and maintenance sevoflurane then the patients will receive the supraclavicular block with bupivacaine 0.5 ml per kg. | Other | General anesthesia plus supraclavicular block. |
Primary outcome
brachiocephalic fistula maturation time
Time frame: 6 month postoperative
time in weeks required by fistula to be clinically mature
4 secondary outcomes
anaesthetic consumption
Time frame: 90 minutes intraoperative
postoperative analgesia time
Time frame: 24 hours postoperative
EMERGENCE agitation
Time frame: 30 minutes postoperative
VAS score
Time frame: 24h postoperative
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 12 Nov 2024.
- Background: PubMed 26171895Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
- Background: PubMed 24907283Suresh S, Schaldenbrand K, Wallis B, De Oliveira GS Jr. Regional anaesthesia to improve pain outcomes in paediatric surgical patients: a qualitative systematic review of randomized controlled trials. Br J Anaesth. 2014 Sep;113(3):375-90. doi: 10.1093/bja/aeu156. Epub 2014 Jun 6.
- Background: PubMed 18544144De Jose Maria B, Banus E, Navarro Egea M, Serrano S, Perello M, Mabrok M. Ultrasound-guided supraclavicular vs infraclavicular brachial plexus blocks in children. Paediatr Anaesth. 2008 Sep;18(9):838-44. doi: 10.1111/j.1460-9592.2008.02644.x. Epub 2008 Jun 9.
- Derived from this study: PubMed 40380096Elsawy S, Fathy E, Elbadawy A, Elnaggar A, Abdelatif AF, Elmorabaa H, Hamed R. Ultrasound-guided supraclavicular brachial plexus block as an additive to sevoflurane anesthesia in pediatrics undergoing brachiobasilic arteriovenous fistula operation: randomized controlled clinical trial. BMC Anesthesiol. 2025 May 16;25(1):248. doi: 10.1186/s12871-025-03091-1.
- Anaesthesia for children with renal disease.Link provided by the sponsor.
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 general anesthesia only. and general anesthesia plus supraclavicular block. in people with Post Operative Pain, run by Assiut 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: finished, as of the sponsor's last update on 12 Nov 2024. 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?
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?
brachiocephalic fistula maturation time (time frame: 6 month postoperative). 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 NCT05580094, which also lists 4 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 12 Nov 2024.