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

NCT ID: NCT05922605

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2025-05-01

Brief 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.

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.

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.

Conditions

Postoperative Analgesia; S-ketamine; Pediatrics; Caudal Block; Hypospadias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group E

the 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.

Group Type: EXPERIMENTAL

S-ketamine & Ropivacaine

Intervention Type: DRUG

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.

Group C

The children are given 0.2%ropivacaine 0.7 ml／kg and saline of equal volume caudally.

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

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

Interventions

S-ketamine & Ropivacaine

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.

Intervention Type: DRUG

Ropivacaine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tao Zhang

OTHER

Sponsor Role: lead

Responsible Party

Tao Zhang

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tao Zhang, M.D.

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Locations

First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

tao Zhang, MD

Role: CONTACT

zhtao98@aliyun.com

8613580482938

weiyi Xu, B.M

Role: CONTACT

xuweiyi75@foxmail.com

8619875691896

Facility Contacts

xia Feng, MD

Role: primary

fengxia@mail.sysu.edu.cn

8613688877856

References

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Reference Type: BACKGROUND

PMID: 15200652 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11696143 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 12641687 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 14742331 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 21642642 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30243061 (View on PubMed)

Other Identifiers

Caudal S-ketamine

Identifier Type: -

Identifier Source: org_study_id