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Completed

NCT Number: NCT01541059

Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo

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.

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Key information

Conditions

Third Molar Extraction

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo injection

Drug

Injection of saline solution into the vestibular capsule of each tooth to be extracted.

Other names: Standard intervention, Saline solution

Ropivacaine injection

Drug

Ropivacaine is injected into the vestibular capsule of each tooth to be extracted.

Other names: Experimental intervention.

Primary outcomes

  1. 24 hour area under the curve for pain

    Time frame: 24 hours

    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 outcomes

  1. Total peroperative consumption of remifentanil

    Time frame: During surgery (approximately 30-50 minutes)

    µg/kg

  2. Total peroperative consumption of propofol

    Time frame: During surgery (approximately 30-50 minutes)

    mg/kg

  3. Post operative pain as measured by a verbal, numeric scale (0 to 10)

    Time frame: Day 1

    score from 0 to 10

  4. Post operative pain as measured by a verbal, numeric scale (0 to 10)

    Time frame: Day 4

    score from 0 to 10

  5. Post operative pain as measured by a verbal, numeric scale (0 to 10)

    Time frame: 1 month

    score from 0 to 10

  6. Post operative pain as measured by a verbal, numeric scale (0 to 10)

    Time frame: 3 months

    score from 0 to 10

  7. Total morphine consumption

    Time frame: Hospital discharge (on average on days 1 or 2)

    mg

  8. Use of rescue pain medicine (yes/no)

    Time frame: Hospital discharge (on average on days 1 or 2)

  9. Total in-hospital Tramadol consumption

    Time frame: Hospital discharge (on average on days 1 or 2)

    mg

  10. Total in-hospital paracetamol consumption

    Time frame: Hospital discharge (on average on days 1 or 2)

    g

  11. Total in-hospital ketoprofen consumption

    Time frame: Hospital discharge (on average on days 1 or 2)

    mg

  12. 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)

    minutes

  13. Length of recovery room stay

    Time frame: Recovery room discharge (Day 1)

    Time elapsed between admittance and discharge from the post-surgical recovery room. (minutes)

  14. Length of hospital stay

    Time frame: Hospital discharge (on average on days 1 or 2)

    Time elapsed between admittance to post-surgical recovery room and hospital discharge (hours)

  15. presence/absence of complications

    Time frame: 6 hours

    pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult glutition, dysarthria

  16. presence/absence of complications

    Time frame: day 1

    pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult glutition, dysarthria

  17. presence/absence of complications

    Time frame: day 3

    pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult glutition, dysarthria

  18. Paracetamol consumption at home

    Time frame: Day 1

    grams

  19. Paracetamol consumption at home

    Time frame: Day 3

    grams

  20. ketoprofen consumption at home

    Time frame: Day 1

    mg

  21. ketoprofen consumption at home

    Time frame: Day 3

    mg

  22. Tramadol consumption at home

    Time frame: Day 1

    mg

  23. Tramadol consumption at home

    Time frame: Day 3

    mg

  24. Patient satisfaction

    Time frame: Day 3

    Patient satisfaction is evaluated via a numeric verbal scale ranging from 0 to 10.

  25. Chronic pain evaluation (DN4)

    Time frame: 1 month

    standard DN4 score

  26. Chronic pain evaluation (DN4)

    Time frame: 3 months

    standard DN4 score

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Postoperative Analgesia in Third Molar Surgery Under General Anesthesia: Ropivacaine Versus Placebo

Acronym: RopiMol

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 29, 2012
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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