Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01522534
Other study ID # chra-2009-001
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 2012
Est. completion date December 2013

Study information

Verified date November 2019
Source Centre Hospitalier Annecy Genevois
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine the efficacity of a simple blind technic of loco regional anaesthesia of the sciatic nerve compared to the gold standard in emergency medecine : the intravenous morphine for treated the severe pain of leg, ankle or foot trauma in the prehospital setting and mountain rescue.


Description:

Severe pain due to leg, ankle or foot trauma do not beneficiated of a simple loco regional anaesthesia technic. Loco regional anesthesia is superior to intravenous morphine for treating severe pain and specially during transportation and mobilization of the patient. The purpose of the study is to assessed a new technic of blind sciatic nerve block in the popliteal fossa in the pre hospital setting compared to the intravenous morphine. The blind technic is a modified technic of the classic sciatic nerve block with nerve stimulation.


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Severe pain (VAS > or = 60mm); injuries of the leg, ankle or foot

Exclusion Criteria:

- Hypersensitivity to student agents

- Local infection

- Nerve or vascular pathology in the affected limb, coagulation pathology,

- Chronic use of opoids, use of opoids within 6 hours

- Drug addiction

- Pregnancy

- Systolic blood pressure less than 90 mmHg

- Respiratory rate less than 16 per minute

- Glasgow coma scale < 14.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mepivacaine
mepivacaine 1% 20 ml corresponding to 200 mg
Morphine
Morphine alone with a placebo nerve block

Locations

Country Name City State
France Centre Hospitalier d'Albertville moutiers Albertville
France Centre Hospitalier de la Region d'Annecy Annecy
France Centre Hospitalier de Chambéry Chambery
France Centre Hospitalier Universitaire de GRENOBLE Grenoble
France Centre medical d'Avoriaz Morzine
France Centre Hospitalier Sallanches Chamonix Sallanches

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Annecy Genevois

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analog scale pain score 30 minutes
Secondary Total dose of morphine 60 minutes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Recruiting NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care