Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption

Dento Facial Dysmorphism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299998
• Other study ID #: CRC_GHN_2017_001
• Status: Completed
• Phase: N/A
• First received: September 14, 2017
• Last updated: October 2, 2017
• Start date: July 25, 2017
• Est. completion date: August 10, 2017

Study information

• Verified date: October 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 10, 2017
• Est. primary completion date: July 25, 2017
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dento Facial Dysmorphism

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative morphine consumption within 24 hours post-surgery	Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).	24 hours
Secondary	Peroperative remifentanil consumption	Remifentanil consumption in µg.kg-1 during surgery	End of surgery (2 hours in average)
Secondary	Cumulative morphine consumption within 12 hours post-surgery	Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).	12 hours
Secondary	Cumulative morphine consumption within 48 hours post-surgery	Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).	48 hours
Secondary	Hospital length of stay	Delay between hospitalization date and date of hospital discharge	Up to hospital discharge (5 days in average)