Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption

Completed

• Conditions: Dento Facial Dysmorphism
• Interventions: Procedure: Maxillary and mandibular blocks; Procedure: General anesthesia

• Registration Number: NCT03299998
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Background and Objectives: Double-jaw surgery is one of the most painful oral surgery, requiring multimodal analgesia including controlled morphine pump and its secondary effects. The aim of this study was to evaluate the effectiveness of face block (mandibulary and maxillary block analgesia) on the first 24 hours on morphine consumption in patients admitted for double jaw surgery.

Detailed Description

Methods: Patients undergoing double-jaw surgery between January 2015 and May 2017 were enrolled. Patients were separated into 2 groups: patients receiving maxillary-mandibulary nerve block and those no receiving it. The primary endpoint was the morphine consumption within 24 hours post-surgery. Secondary endpoints were the intra-operative remifentanil consumption, incidence of postoperative nausea and vomiting at 24 hours, morphine consumption in recovery room, length of stay in hospital.

Study Timeline

• Study Start: 2017-07-25
• Primary Completion: 2017-07-25
• Study Completion: 2017-08-10
• Study First Submitted: 2017-09-14
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-02
• Last Update Submitted: 2017-10-02
• Study First Posted: 2017-10-03
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 92

Inclusion Criteria

• Male and female who underwent double jaw surgery

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Exclusion Criteria

• opposition to the study
• an additional surgical procedure
• preoperative consumption of morphine or derived from morphine
• perioperative N20

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BLOCK+	General anesthesia	Patients who underwent maxillary and mandibulary block before surgery
BLOCK -	General anesthesia	Patients who did not undergo maxillary and mandibulary block before surgery.
BLOCK+	Maxillary and mandibular blocks	Patients who underwent maxillary and mandibulary block before surgery

Primary Outcome Measures

Name	Time	Method
Cumulative morphine consumption within 24 hours post-surgery	24 hours	Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).

Secondary Outcome Measures

Name	Time	Method
Peroperative remifentanil consumption	End of surgery (2 hours in average)	Remifentanil consumption in µg.kg-1 during surgery
Cumulative morphine consumption within 12 hours post-surgery	12 hours	Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).
Hospital length of stay	Up to hospital discharge (5 days in average)	Delay between hospitalization date and date of hospital discharge
Cumulative morphine consumption within 48 hours post-surgery	48 hours	Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France