Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo (RopiMol)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01541059
First received: February 20, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

The main objective of this study is to demonstrate the superiority of local analgesia with ropivacaine versus placebo on postoperative pain during the first 24 hours following bilateral surgery of all four third molars under general anesthesia.


Condition Intervention Phase
Third Molar Extraction
Drug: Placebo injection
Drug: Ropivacaine injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia in Third Molar Surgery Under General Anesthesia: Ropivacaine Versus Placebo

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 24 hour area under the curve for pain [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Pain is assessed via a numeric, verbal scale (0 to 10) at baseline and then at 1.5, 2, 3, 4, 6 and 24 hours after surgery. The area under the resulting curve is calculated.


Secondary Outcome Measures:
  • Total peroperative consumption of remifentanil [ Time Frame: During surgery (approximately 30-50 minutes) ] [ Designated as safety issue: No ]
    µg/kg

  • Total peroperative consumption of propofol [ Time Frame: During surgery (approximately 30-50 minutes) ] [ Designated as safety issue: No ]
    mg/kg

  • Post operative pain as measured by a verbal, numeric scale (0 to 10) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    score from 0 to 10

  • Post operative pain as measured by a verbal, numeric scale (0 to 10) [ Time Frame: Day 4 ] [ Designated as safety issue: Yes ]
    score from 0 to 10

  • Post operative pain as measured by a verbal, numeric scale (0 to 10) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    score from 0 to 10

  • Post operative pain as measured by a verbal, numeric scale (0 to 10) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    score from 0 to 10

  • Total morphine consumption [ Time Frame: Hospital discharge (on average on days 1 or 2) ] [ Designated as safety issue: No ]
    mg

  • Use of rescue pain medicine (yes/no) [ Time Frame: Hospital discharge (on average on days 1 or 2) ] [ Designated as safety issue: No ]
  • Total in-hospital Tramadol consumption [ Time Frame: Hospital discharge (on average on days 1 or 2) ] [ Designated as safety issue: No ]
    mg

  • Total in-hospital paracetamol consumption [ Time Frame: Hospital discharge (on average on days 1 or 2) ] [ Designated as safety issue: No ]
    g

  • Total in-hospital ketoprofen consumption [ Time Frame: Hospital discharge (on average on days 1 or 2) ] [ Designated as safety issue: No ]
    mg

  • Time elapsed between release from post-surgical recovery room and first request for rescue medicine [ Time Frame: Hospital discharge (on average on days 1 or 2) ] [ Designated as safety issue: No ]
    minutes

  • Length of recovery room stay [ Time Frame: Recovery room discharge (Day 1) ] [ Designated as safety issue: No ]
    Time elapsed between admittance and discharge from the post-surgical recovery room. (minutes)

  • Length of hospital stay [ Time Frame: Hospital discharge (on average on days 1 or 2) ] [ Designated as safety issue: No ]
    Time elapsed between admittance to post-surgical recovery room and hospital discharge (hours)

  • presence/absence of complications [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult glutition, dysarthria

  • presence/absence of complications [ Time Frame: day 1 ] [ Designated as safety issue: Yes ]
    pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult glutition, dysarthria

  • presence/absence of complications [ Time Frame: day 3 ] [ Designated as safety issue: Yes ]
    pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult glutition, dysarthria

  • Paracetamol consumption at home [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    grams

  • Paracetamol consumption at home [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    grams

  • ketoprofen consumption at home [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    mg

  • ketoprofen consumption at home [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    mg

  • Tramadol consumption at home [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    mg

  • Tramadol consumption at home [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    mg

  • Patient satisfaction [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Patient satisfaction is evaluated via a numeric verbal scale ranging from 0 to 10.

  • Chronic pain evaluation (DN4) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    standard DN4 score

  • Chronic pain evaluation (DN4) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    standard DN4 score


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Patients in this arm will have standard anesthesia with the injection of placebo solution into the vestibular of each tooth to be extracted
Drug: Placebo injection
Injection of saline solution into the vestibular capsule of each tooth to be extracted.
Other Names:
  • Standard intervention
  • Saline solution
Experimental: Ropivacaine
Patients in this arm will have general anesthesia with injection of ropivacaine into the vestibular next to each tooth to be extracted.
Drug: Ropivacaine injection
Ropivacaine is injected into the vestibular capsule of each tooth to be extracted.
Other Name: Experimental intervention.

Detailed Description:

The secondary objectives of this study are to compare regional anesthesia by ropivacaine versus placebo for the bilateral resection of all four third molars under general anesthesia, in terms of:

A. intraoperative use of propofol and remifentanil B. postoperative pain (EVN) at different time points C. in-hospital analgesic consumption D. time to first rescue analgesic request E. time spent in the post interventional treatment room F. length of hospital stay G. side effects H. analgesic consumption at home I. analgesic consumption (total) J. patient satisfaction K. Chronic pain after surgery

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 3 months of follow-up
  • American Society of Anesthesiology (ASA) score of 1, 2 or 3
  • Patient programmed for surgical removal of all 4 wisdom teeth, excluding all other teeth, under general anesthesia

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is over 18 years old and under judicial protection, under tutorship or curatorship
  • The patient (or legal representative)refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • Ineffective contraceptive
  • Addiction or chronic pain treated with morphine
  • Contra-indication for regional anesthesia (eg congenital or acquired coagulopathy, infection, allergy)
  • Contra-indication to local anesthetics, general anesthetics and analgesics used in the protocol.
  • Difficult cooperation, psychiatric disorders that could interfere with assessments
  • Hypersensitivity to ropivacaine or other local anesthetics with amide links
  • Contra-indication for the use of NaCl 0.9%: all states of sodium and water retention (especially heart failure, edema and ascites syndrome associated with cirrhosis)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541059

Contacts
Contact: Jacques Ripart, MD PhD +33.(0)4.66.68.30.50 jacques.ripart@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Jacques Ripart, MD PhD         
Sub-Investigator: Hamadi Ghezal, MD         
Sub-Investigator: Sylvie Rayan, MD         
Sub-Investigator: Michèle Abriquet, MD         
Sub-Investigator: Olivier Ruinet, MD         
Sub-Investigator: Bernadette Charaval, MD         
Sub-Investigator: Geneviève Lafare, MD         
Sub-Investigator: Philippe Lapeyrie, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jacques Ripart, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01541059     History of Changes
Other Study ID Numbers: LOCAL/2011/JR/HG-02, 2011-004972-13
Study First Received: February 20, 2012
Last Updated: March 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Third molar extraction
local anesthesia
ropivacaine

Additional relevant MeSH terms:
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014