Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption

Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption in Double-jaw Surgery, a Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Dento Facial Dysmorphism
• Intervention / Treatment: Procedure: Maxillary and mandibular blocks; Procedure: General anesthesia

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 Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Male and female who underwent double jaw surgery

Description

Inclusion Criteria:

- Male and female who underwent double jaw surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BLOCK+; Patients who underwent maxillary and mandibulary block before surgery	Procedure: Maxillary and mandibular blocks; A Pajunk SonoPlex Stim needle 22G x 55 mm was used. For maxillary nerve block, needle was introduced next to the angle of the orbitae and the zygomatic ridge. The needle was sank until coming into contact of the temporal bone. It was then orientated to the controlateral nostril and sank of 1 cm. For mandibular block, needle was introduced in the pterygoid fossa under and perpendicularly to the zygomatic arch, and sank until the pterygoid process. The needle was then orientated towards controlateral orbitae and sank with neurostimulation. After a motor response at 0.6 milliampere (mA) and the disappearance of contraction at 0.3 mA, local mixture was injected. The mixing of local anesthesia was made of ropivacaine 5 mg/mL and clonidine 30 µg. Five mL were injected in every block for a total of 20 mL.; Procedure: General anesthesia; Anesthesia was standardized and provided using intravenous administration of propofol and remifentanil. Patients were mechanically ventilated with a mixture of air (50/50), and desflurane or sevoflurane, or Target-controlled infusion (TCI) propofol. One to 5 mg/kg of methyl-prednisolone were administered to reduce inflammatory response.
BLOCK -; Patients who did not undergo maxillary and mandibulary block before surgery.	Procedure: General anesthesia; Anesthesia was standardized and provided using intravenous administration of propofol and remifentanil. Patients were mechanically ventilated with a mixture of air (50/50), and desflurane or sevoflurane, or Target-controlled infusion (TCI) propofol. One to 5 mg/kg of methyl-prednisolone were administered to reduce inflammatory response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative morphine consumption within 24 hours post-surgery	Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Actual): July 25, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CRC_GHN_2017_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No