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AzTrials

Postoperative AnalgesiaPhase 4NCT05922605

Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias

A Phase 4 study testing S-ketamine & Ropivacaine and Ropivacaine in people with Postoperative Analgesia and S-ketamine, run by Tao Zhang at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. However, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious. Read more about this study

Who is it for?
Ages 3 months to 18 years, men only
Conditions the study is for
Postoperative Analgesia, S-ketamine, Pediatrics
What is being tested?
S-ketamine & Ropivacaine and Ropivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
20 Jun 2023to 1 May 2025
Phase
Phase 4
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 months to 18 years
  • Men only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • informed parent consent, ASA I or II children, between 3months and 18 years of age,and weighing <28kg, scheduled for elective hypospadias surgery with general anesthesia will be recruited.

Who cannot join

  • Patients who have congenital abnormalities of lower spine and meninges.
  • Patients with hypersensitivity to any local anesthetics
  • Children with coagulation disorders
  • Presence of Infections at puncture sites
  • Preexisting neurological disease
  • Refusal to consent by parent/guardian

Trial locations and contacts

1 site in 1 country.

tao Zhang, MD contact

8613580482938

zhtao98@aliyun.com

weiyi Xu, B.M contact

8619875691896

xuweiyi75@foxmail.com

China1 site, 1 recruiting

  • First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    xia Feng, MD, 8613688877856, fengxia@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. However, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious.

Ketamine as an additive to caudal administration had been shown to prolong the duration of postoperative analgesia, while the analgesic effectiveness of S-ketamine, the S(+)-enantiomer of ketamine with less possibility to induce psychomotor disturbances, is not clear. In this prospective randomized double-blind clinical trial , the investigators aimed to study the effect of S-ketamine as additive on the duration of caudal analgesia.

Read the detailed description

Forty-four children scheduled for hypospadias randomize into 2 groups. Group E (n=22) (0.2% ropivacaine 0.7 ml／kg and S-ketamine 0.5 mg/kg), group C(n=22)( 0.2%ropivacaine 0.7ml／kg and equivalent saline) intraoperative and postoperative hemodynamics will be recorded. Postoperative pain is assessed using an established 6-item FLACC score at 1h,3h,6h,12h,24h,48h, or the time when children complain of pain after surgery. A score of more15μg/kg is administered.Investigators propose to compare the duration of caudal analgesia provided by plain ropivacaine and by a mixture of ropivacaine and S-ketamine.

Being tested
S-ketamine & Ropivacaine, Ropivacaine
Medical subject headings
Hypospadias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-ketamine & RopivacaineDrug

    The experiment group (Group E) will receive a mixture of ropivacaine 0.2% 0.7 ml／kg and preservative-free S-ketamine 0.5 mg/kg caudally for postoperative analgesia.

  • RopivacaineDrug

    The experiment group (Group C) will receive ropivacaine 0.2% 0.7 ml／kg plain and equial volume saline caudally for postoperative analgesia.

Study groups in NCT05922605
Study groupRoleWhat they receive
Group EExperimentalthe children are given a mixture of 0.2%ropivacaine 0.7 ml／kg and preservative-free S-ketamine 0.5 mg/kg for caudal analgesia.
Receives: Drug: S-ketamine & Ropivacaine
Group CActive comparatorThe children are given 0.2%ropivacaine 0.7 ml／kg and saline of equal volume caudally.
Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. duration of caudal analgesia

    Duration of analgesia is defined as the time from caudal injection to the first need for systemic analgesia.

    Measured: 48 hours after the caudal injection

Secondary outcomes (3)

  1. morphine consumption

    The Face, Legs, Activity, Cry, and Consolability (FLACC) scale at 1 hour (h), 3h,6h,12h,24h,48h or the time when children complain of pain after surgery. A score of more than 3 points is taken as an indication of inadequate analgesia and morphine 15ug/kg was administered .

    Measured: 48 hours after caudal block

  2. FLACC score

    The Face, Legs, Activity, Cry, and Consolability (FLACC) scale

    Measured: 48 hours after the caudal block

  3. complication

    the incidence of residual motor block, urinary retention, paraesthesia; the incidence of respiratory depression ,vomiting ,nystagmus ,pruritus，odd behavior;.the sedation scores etc.

    Measured: 48 hours after the caudal block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start20 Jun 2023
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion1 May 2025 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05922605
Sponsor's protocol ID
Caudal S-ketamine
Status last verified
Oct 2023
First submitted
15 Jun 2023
Last updated
30 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gunes Y, Secen M, Ozcengiz D, Gunduz M, Balcioglu O, Isik G. Comparison of caudal ropivacaine, ropivacaine plus ketamine and ropivacaine plus tramadol administration for postoperative analgesia in children. Paediatr Anaesth. 2004 Jul;14(7):557-63. doi: 10.1111/j.1460-9592.2004.01220.x.

    PubMed 15200652

  • De Negri P, Ivani G, Visconti C, De Vivo P. How to prolong postoperative analgesia after caudal anaesthesia with ropivacaine in children: S-ketamine versus clonidine. Paediatr Anaesth. 2001 Nov;11(6):679-83. doi: 10.1046/j.1460-9592.2001.00742.x.

    PubMed 11696143

  • Weber F, Wulf H. Caudal bupivacaine and s(+)-ketamine for postoperative analgesia in children. Paediatr Anaesth. 2003 Mar;13(3):244-8. doi: 10.1046/j.1460-9592.2003.01018.x.

    PubMed 12641687

  • Martindale SJ, Dix P, Stoddart PA. Double-blind randomized controlled trial of caudal versus intravenous S(+)-ketamine for supplementation of caudal analgesia in children. Br J Anaesth. 2004 Mar;92(3):344-7. doi: 10.1093/bja/aeh076. Epub 2004 Jan 22.

    PubMed 14742331

  • Koinig H, Marhofer P, Krenn CG, Klimscha W, Wildling E, Erlacher W, Nikolic A, Turnheim K, Semsroth M. Analgesic effects of caudal and intramuscular S(+)-ketamine in children. Anesthesiology. 2000 Oct;93(4):976-80. doi: 10.1097/00000542-200010000-00017.

    PubMed 11020749

  • Brenner L, Marhofer P, Kettner SC, Willschke H, Machata AM, Al-Zoraigi U, Lundblad M, Lonnqvist PA. Ultrasound assessment of cranial spread during caudal blockade in children: the effect of different volumes of local anaesthetics. Br J Anaesth. 2011 Aug;107(2):229-35. doi: 10.1093/bja/aer128. Epub 2011 Jun 3.

    PubMed 21642642

  • Narasimhan P, Kashyap L, Mohan VK, Arora MK, Shende D, Srinivas M, Kashyap S, Nath S, Khanna P. Comparison of caudal epidural block with paravertebral block for renal surgeries in pediatric patients: A prospective randomised, blinded clinical trial. J Clin Anesth. 2019 Feb;52:105-110. doi: 10.1016/j.jclinane.2018.09.007. Epub 2018 Sep 19.

    PubMed 30243061

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing S-ketamine & Ropivacaine and Ropivacaine in people with Postoperative Analgesia and S-ketamine, run by Tao Zhang at 1 site in China.

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 6 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: status not confirmed, as of the sponsor's last update on 30 Oct 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 China. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact tao Zhang, MD (8613580482938, zhtao98@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

duration of caudal analgesia (time frame: 48 hours after the caudal injection). 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 NCT05922605, which also lists 7 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 30 Oct 2023.

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