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

Pudendal Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496325
• Other study ID #: 9397
• Secondary ID: 2014-A00499-38
• Status: Completed
• Phase: N/A
• First received: June 23, 2015
• Last updated: July 13, 2015
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Description:

After obtaining parental consent, children aged 1-15 years, physical status score I-III, requiring general anesthesia associated with bilateral pudendal nerve block (PNB) for elective perineal surgery in the investigators' paediatric surgery unit, were successively included. Exclusion criteria were any contraindication to general or loco regional anesthesia, and physical status score IV-V. Management of general anesthesia was standardized. Propofol and/or sevoflurane were used for induction, in association with a continuous infusion of remifentanil at 1µg/kg/min during two minutes. After this delay, airway control was assured through insertion of a tracheal tube or a laryngeal mask. Maintenance of anesthesia was then achieved with Sevoflurane (1.2 MAC) in a mix 02/N2 and remifentanil 0.05 µg/kg/min. Mechanical ventilation parameters were adapted to obtain a normal End-tidal carbon dioxide (EtCO2) (28-34 mmHg). Baseline values of blood pressure and heart rate under general anesthesia without nociceptive stimulation were measured.Ultrasound guided pudendal nerve block was then performed. For each block, data about sonographic identification of anatomical structures, visualization of needle and local anaesthetic spread were collected. The response to nerve stimulation, puncture complications and duration of the procedure were also noted. During perineal operative time, a rise up in blood pressure or in heart rate more than 20% compared to baseline values was considered as a PNB failure. Analgesia was then provided by an incremental increase of remifentanil, to obtain a return to baseline hemodynamic parameters. The maximum rate of infusion of remifentanil was collected. All patients received intravenous post-operative analgesia by acetaminophen 15 mg/kg and ketoprofen 1mg/kg. Rescue analgesia by IV nalbuphine 0.2 mg/kg was administered in recovery room if necessary. Post-operative analgesia by oral acetaminophen associated with ibuprofen, and rescue analgesia with oral tramadol were prescribed. Data on post-operative analgesia were collected up to 24h after recovery room admission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

1. Patient hospitalized in pediatric surgery unit for elective perineal surgery to which the use of pudendal block is relevant and current practice.

2. patient physical status score I-III classification

3. Patient of both sexes

4. Patient aged 1 year to 15 years of age

5. Patient whose parents have given their informed consent.

6. Patient affiliated to a social security scheme or of such a regime

Exclusion Criteria:

1. Patient who participated in the previous month to a therapeutic trial or currently included in another test

2. Patient with bleeding disorders

3. Patient with infection (Fasciocutaneous subcutaneous) at the puncture area

4. Patient with allergies to local anesthetics

5. patients with a contraindication to general anesthesia

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pudendal Nerve Block

Intervention

Procedure:
• Ultrasound guided transperineal pudendal nerve block
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.

Locations

Country	Name	City	State
France	University hospital Lapeyronie	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of visualization (with specific scale: good, medium, bad quality) of local anesthetic injection within the ischiorectale pit under ultrasound.		intraoperative	No
Secondary	Quality of visualization (with specific scale: good, medium, bad quality) of target anatomical structures, of needle tip		intraoperative	No