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Completed

NCT Number: NCT03299998

Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption

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.

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Key information

Study type

Observational

Primary location

Hospices Civils de Lyon

Lyon, 69004, France

About this study

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.

Who can participate

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

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

Treatment and study plan

Maxillary and mandibular blocks

Procedure

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

Procedure

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.

Primary outcomes

  1. Cumulative morphine consumption within 24 hours post-surgery

    Time frame: 24 hours

    Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).

Secondary outcomes

  1. Peroperative remifentanil consumption

    Time frame: End of surgery (2 hours in average)

    Remifentanil consumption in µg.kg-1 during surgery

  2. Cumulative morphine consumption within 12 hours post-surgery

    Time frame: 12 hours

    Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).

  3. Cumulative morphine consumption within 48 hours post-surgery

    Time frame: 48 hours

    Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).

  4. Hospital length of stay

    Time frame: Up to hospital discharge (5 days in average)

    Delay between hospitalization date and date of hospital discharge

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2017
Registry last updated
Oct 3, 2017

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.