Pudendal Nerve BlockNCT02496325
Ultrasound-guided Pudendal Nerve Block in Children: A Descriptive Study of Feasibility
A study testing Ultrasound guided transperineal pudendal nerve block in people with Pudendal Nerve Block, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Pudendal Nerve Block
- What is being tested?
- Ultrasound guided transperineal pudendal nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Feb 2015
- Phase
- Interventional
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Pudendal Nerve Block
- Being tested
- Ultrasound guided transperineal pudendal nerve block
- Keywords
- Pudendal nerve block, Ultrasound guided, Transperineal puncture, Perineal surgery, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided transperineal pudendal nerve blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| perineal technic | Other | Not described Receives: Procedure: Ultrasound guided transperineal pudendal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of visualization (with specific scale: good, medium, bad quality) of local anesthetic injection within the ischiorectale pit under ultrasound.
Measured: intraoperative
Secondary outcomes (1)
Quality of visualization (with specific scale: good, medium, bad quality) of target anatomical structures, of needle tip
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pudendal Nerve BlockStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle IG GAUDET-FERRAND, MD, Principal investigator, Department of Anesthesia Resuscitation at the Hospital Lapeyronie in Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496325
- Sponsor's protocol ID
- 9397
- Other IDs
- 2014-A00499-38
- Status last verified
- Jun 2015
- First submitted
- 23 Jun 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Pudendal Nerve Block in Children: A Descriptive Study of Feasibility
- ClinicalTrials.gov ID
- NCT02496325
- Acronym / sponsor ID
- 9397
- Conditions
- Pudendal Nerve Block
- Keywords
- Pudendal nerve block, Ultrasound guided, Transperineal puncture, Perineal surgery, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| perineal technic | Other | Procedure: Ultrasound guided transperineal pudendal nerve block |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided transperineal pudendal nerve blockChildren 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. | Procedure or surgery | perineal technic |
Primary outcome
Quality of visualization (with specific scale: good, medium, bad quality) of local anesthetic injection within the ischiorectale pit under ultrasound.
Time frame: intraoperative
1 secondary outcome
Quality of visualization (with specific scale: good, medium, bad quality) of target anatomical structures, of needle tip
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia
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Repeated Pudendal Nerve Block and Physiotherapy for Prevention of Chronic Post-Episiotomy Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle IG GAUDET-FERRAND, MD principal investigator
Department of Anesthesia Resuscitation at the Hospital Lapeyronie in Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided transperineal pudendal nerve block in people with Pudendal Nerve Block, run by University Hospital, Montpellier at 1 site in France.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jul 2015. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of visualization (with specific scale: good, medium, bad quality) of local anesthetic injection within the ischiorectale pit under ultrasound. (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2015.