Ultrasound-guided Pudendal Nerve Block in Children: A Descriptive Study of Feasibility

NCT02496325 | Completed

• 2 other identifiers: 93972014-A00499-38
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Description of a new transperineal technique of pudendal nerve block (PNB), under ultrasound-guidance. Methods : Successive inclusions after parental consent of 60 children undergoing perineal surgery under general anesthesia and pudendal nerve block. Data were collected from induction of anesthesia to second post-operative day (24 hrs. after admission in recovery room). Ease of PNB achievement was the primary objective evaluated. Efficiency in preoperative and postoperative period was also reported.

Conditions

Pudendal Nerve Block

Keywords

Pudendal nerve block; Ultrasound guided; Transperineal puncture; Perineal surgery; children

Outcome Measures

Primary Outcomes (1)

• Quality of visualization (with specific scale: good, medium, bad quality) of local anesthetic injection within the ischiorectale pit under ultrasound.

  intraoperative

Secondary Outcomes (1)

• Quality of visualization (with specific scale: good, medium, bad quality) of target anatomical structures, of needle tip

  intraoperative

Study Arms (1)

perineal technic

OTHER

Procedure: Ultrasound guided transperineal pudendal nerve block

Interventions

Ultrasound guided transperineal pudendal nerve block PROCEDURE

Children under general anesthesia were positioned supine, flexed legs and balls of the feet joined. A 12 MegaHertz (MHz) (38 mm) ultrasound probe was positioned on a horizontal axis passing through the ischial tuberosity, previously palpated.The probe was then moved medially on the axis, until the rectum appeared. Pudendal artery was identified if possible, using colour Doppler. The needle (22 Ga, 50 mm) was then introduced at the middle of the superior edge of the probe, in an out-of-plane approach. Tip of the needle was identified by direct vision, through displacement of adjacent anatomical structures or with saline injection. Nerve stimulation was started after placement of the tip of needle in the ischiorectal fossa, before local anaesthetic injection. After a negative aspiration test, a mix of Ropivacaine 2 % and clonidine 0.2µg/kg was injected in the ischiorectal fossa under ultrasound guidance.

perineal technic

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient hospitalized in pediatric surgery unit for elective perineal surgery to which the use of pudendal block is relevant and current practice.
• patient physical status score I-III classification
• Patient of both sexes
• Patient aged 1 year to 15 years of age
• Patient whose parents have given their informed consent.
• Patient affiliated to a social security scheme or of such a regime

You may not qualify if:

• Patient who participated in the previous month to a therapeutic trial or currently included in another test
• Patient with bleeding disorders
• Patient with infection (Fasciocutaneous subcutaneous) at the puncture area
• Patient with allergies to local anesthetics
• patients with a contraindication to general anesthesia

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital Lapeyronie

Montpellier, 34295, France

Location

Study Officials

• Isabelle IG GAUDET-FERRAND, MD

  Department of Anesthesia Resuscitation at the Hospital Lapeyronie in Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: July 14, 2015
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 14, 2015

Record last verified: 2015-06

Locations

FR (1)