Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children

NCT03931850 | Unknown DMC

• 1 other identifier: 12-61-49
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aim to compare efficacy of transperineal pudendal nerve block between 2 techniques, by dual guidance (ultrasound and neurostimulation) vs by ultrasound-guided only, in pediatric patients who undergo circumcision. Primary outcome : Block efficacy will be assessed from ratio of patients who receive opioids in immediate postoperative period. Secondary outcomes :

• This study also measure other aspects of pain which can reflect the block efficacy including pain score in 24 hours, postoperative analgesic requirement in 24 hours, time to first analgesia, block success rate.
• Block performance : imaging time, needling time, total performance time,
• Block safety : collect complications from block including vascular/rectal puncture, bleeding (hematoma), local anesthetic systemic toxicity, voiding difficulty
• Parental satisfaction will be also collected which scoring use 1-5 metric.

Conditions

Phimosis

Keywords

Pudendal nerve; circumcision; pediatric

Outcome Measures

Primary Outcomes (1)

• the proportion of patients who need opioids in recovery room

  the proportion of patients who need opioids in recovery room in each group

  1 hour (in recovery room)

Secondary Outcomes (8)

• Block success rate

  Intraoperation

• Postoperative analgesic requirement in 24 hours

  24 hours postoperation

• Time to first analgesic medication

  24 hours after operation

• Pain score will be assessed by Face Legs Activity Cry Consolability scale (FLACCs)

  6 hours after arriving the ward

• Parents' Postoperative Pain Measure-Short Form (PPPM-SF)

  6 hours after arriving the ward untill 24 hours after operation

Study Arms (2)

Dual guidance (ultrasound and neurostimulation)

EXPERIMENTAL

This arm : patients will be received pudendal nerve block by dual guidance technique ( ultrasound and neurostimulation)

Procedure: Pudendal nerve block

ultrasound-guided only

ACTIVE COMPARATOR

This arm : patients will be received pudendal nerve block by ultrasound-guided only.

Procedure: Pudendal nerve block

Interventions

Pudendal nerve block PROCEDURE

Pudendal nerve block is the one of peripheral nerve block. Injection local anesthetic medication around this nerve can provide analgesia around perineal area.

Dual guidance (ultrasound and neurostimulation); ultrasound-guided only

Eligibility Criteria

• Age: 8 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 8 months to 7 years
• American Society of Anesthesiologists (ASA) class 1-3
• Undergoing elective circumcision
• Consent to participate in research by the parents signing the letter of intent to participate in the research project

You may not qualify if:

• Refuse to receive regional nerve block
• Allergic to Bupivacaine or Paracetamol
• Coagulopathy
• Severe coexisting liver or kidney disease
• There is a wound or infection in the pelvis area
• Underlying neurodeficit including attention deficit, cerebral palsy, Down's syndrome
• Parents cannot evaluate pain scores
• Patients or parents have willing to withdraw from research.

Sponsors & Collaborators

• Ramathibodi Hospital: lead
• Maharaj Nakorn Chiang Mai Hospital: collaborator

Study Sites (1)

Ramathibodi Hospital

Bangkok, Ratchathewi, 10400, Thailand

RECRUITING

Related Publications (16)

• Yeoman PM, Cooke R, Hain WR. Penile block for circumcision? A comparison with caudal blockade. Anaesthesia. 1983 Sep;38(9):862-6. doi: 10.1111/j.1365-2044.1983.tb12251.x.

  PMID: 6625133 BACKGROUND

• Vater M, Wandless J. Caudal or dorsal nerve block? A comparison of two local anaesthetic techniques for postoperative analgesia following day case circumcision. Acta Anaesthesiol Scand. 1985 Feb;29(2):175-9. doi: 10.1111/j.1399-6576.1985.tb02180.x.

  PMID: 3976329 BACKGROUND

• Tree-Trakarn T, Pirayavaraporn S. Postoperative pain relief for circumcision in children: comparison among morphine, nerve block, and topical analgesia. Anesthesiology. 1985 Apr;62(4):519-22. doi: 10.1097/00000542-198504000-00027. No abstract available.

  PMID: 3885795 BACKGROUND

• Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.

  PMID: 30074928 BACKGROUND

• Ivani G, Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, Krane E, Veyckemans F, Polaner DM, Van de Velde M, Neal JM. The European Society of Regional Anaesthesia and Pain Therapy and the American Society of Regional Anesthesia and Pain Medicine Joint Committee Practice Advisory on Controversial Topics in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):526-32. doi: 10.1097/AAP.0000000000000280.

  PMID: 26192549 BACKGROUND

• Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.

  PMID: 29319604 BACKGROUND

• Tutuncu AC, Kendigelen P, Ashyyeralyeva G, Altintas F, Emre S, Ozcan R, Kaya G. Pudendal Nerve Block Versus Penile Nerve Block in Children Undergoing Circumcision. Urol J. 2018 May 3;15(3):109-115. doi: 10.22037/uj.v0i0.4292.

  PMID: 29299888 BACKGROUND

• Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.

  PMID: 27501015 BACKGROUND

• Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA. The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg. 2013 Dec;117(6):1401-7. doi: 10.1213/ANE.0b013e3182a8ee52.

  PMID: 24257391 BACKGROUND

• Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25.

  PMID: 21790518 BACKGROUND

• Gaudet-Ferrand I, De La Arena P, Bringuier S, Raux O, Hertz L, Kalfa N, Sola C, Dadure C. Ultrasound-guided pudendal nerve block in children: A new technique of ultrasound-guided transperineal approach. Paediatr Anaesth. 2018 Jan;28(1):53-58. doi: 10.1111/pan.13286. Epub 2017 Dec 5.

  PMID: 29205687 BACKGROUND

• Hecht S, Pineda J, Bayne A. Ultrasound-guided Pudendal Block Is a Viable Alternative to Caudal Block for Hypospadias Surgery: A Single-Surgeon Pilot Study. Urology. 2018 Mar;113:192-196. doi: 10.1016/j.urology.2017.11.006. Epub 2017 Nov 16.

  PMID: 29155191 BACKGROUND

• Mamlouk MD, vanSonnenberg E, Dehkharghani S. CT-guided nerve block for pudendal neuralgia: diagnostic and therapeutic implications. AJR Am J Roentgenol. 2014 Jul;203(1):196-200. doi: 10.2214/AJR.13.11346.

  PMID: 24951215 BACKGROUND

• Naja Z, Ziade MF, Lonnqvist PA. Nerve stimulator guided pudendal nerve block decreases posthemorrhoidectomy pain. Can J Anaesth. 2005 Jan;52(1):62-8. doi: 10.1007/BF03018582.

  PMID: 15625258 BACKGROUND

• Naja Z, El-Rajab M, Al-Tannir M, Ziade F, Zbibo R, Oweidat M, Lonnqvist PA. Nerve stimulator guided pudendal nerve block versus general anesthesia for hemorrhoidectomy. Can J Anaesth. 2006 Jun;53(6):579-85. doi: 10.1007/BF03021848.

  PMID: 16738292 BACKGROUND

• Chow S, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed: Chapman&Hall/CRC; 2003

  BACKGROUND

MeSH Terms

Conditions

Phimosis

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Witchaya Supaopaspan, medical

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

• Artid Samerchua, medical

  Maharaj Nakorn Chiang Mai Hospital

  STUDY DIRECTOR

Central Study Contacts

Witchaya Supaopaspan, medical

CONTACT

66891992599; widjy14@hotmail.com

Artid Samerchua, medical

CONTACT

66826944496; artidsamerchua@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 30, 2019
• Study Start: April 30, 2019
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)