Overview

This trial is active, not recruiting.

Condition outpatient rhinoplasty
Treatment bilateral facial block after general anesthesia before surgery
Phase phase 3
Sponsor Hospices Civils de Lyon
Start date June 2013
End date December 2013
Trial size 40 participants
Trial identifier NCT01872728, 2012-005831-97, 2012.774

Summary

A bilateral facial block (infraorbital and infratrochlear) will be performed immediately after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine (intervention group) or saline as control. Intravenous saline or morphine will be administered at the end of surgery in intervention or control groups, respectively. In case of pain in post-anesthesia care unit (numerical pain score >3 on a 0-10 scale), both groups will receive intravenous morphine titration. The total perioperative morphine consumption (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain intensity, presence of nausea/vomiting and patient's satisfaction will be compared between groups.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
placebo for the realization of the facial block and morphine for intraoperative analgesia
bilateral facial block after general anesthesia before surgery
Bilateral facial block (infraorbital and infratrochlear) after general anesthesia before surgery with intravenous placebo or bilateral block with placebo and intravenous morphine
(Active Comparator)
Levobupivacaine for the realization of the facial block and placebo for intraoperative analgesia
bilateral facial block after general anesthesia before surgery
Bilateral facial block (infraorbital and infratrochlear) after general anesthesia before surgery with intravenous placebo or bilateral block with placebo and intravenous morphine

Primary Outcomes

Measure
Total morphine consumption during the perioperative period (operating theater and post-anesthesia care unit)
time frame: J0

Secondary Outcomes

Measure
Pain intensity in post-anesthesia care unit
time frame: J0 (At arrival in post-operative care unit)
Postoperative nausea and vomiting
time frame: J1 (At day 1 after surgery)
Patient satisfaction at day 1
time frame: J1 (At day 1 after surgery)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Outpatient rhinoplasty - American Society of Anesthesiologists (ASA) classification I-II - Affiliated to Social Security - Written informed consent Exclusion Criteria: - Allergy to levobupivacaine - Incapacity to give consent - Chronic pain

Additional Information

Official title Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.