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Four vs. Ten Local Anesthetic Injections for SMR

NCT02463370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-01-10

No results posted yet for this study

Summary

Submucosal resection of the nasal septum (SMR) could be performed under local anesthetic infiltration performed through ten injections in addition to general anesthesia which was associated with less postoperative pain and shorter hospital stay.

However, the local infiltration technique is time-consuming and requires a large number of facial injections. This gave rise to the idea of reducing the number of injections while retaining the effectiveness of the local anesthetic technique.

Decreasing the number of injections could be achieved by blocking the superior maxillary nerve (V2) and the infra-orbital nerve since it would result in anesthetizing the surgical area as well after induction of general anesthesia.

The purpose of this prospective double-blind clinical trial was to compare the effectiveness of four versus ten local anesthetic injections in terms of postoperative pain relief. The secondary objective was to compare patients' and surgeons' satisfaction between the two techniques.

Conditions

  • Submucosal Resection of the Nasal Septum (SMR)

Interventions

OTHER

suprazygomatic maxillary area infiltration

Local anesthetic infiltration in two injections on each side of the face at the maxillary and infra-orbital areas.

OTHER

non-suprazygomatic maxillary area placebo

The remaining injections at supratrochlear area, medial to the medial canthus, nasal still and anterior septum are placebo (saline)

OTHER

non-suprazygomatic maxillary area infiltration

Local anesthetic infiltration in five injections on each side of the face at the infra-orbital area, supratrochlear area, medial to the medial canthus, nasal still and anterior septum.

OTHER

suprazygomatic maxillary area placebo

The remaining maxillary injection is placebo.

Sponsors & Collaborators

  • Makassed General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02463370 on ClinicalTrials.gov