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Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

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University of Florida

Status and phase

Enrolling
Phase 4

Conditions

Deviated Nasal Septum

Treatments

Drug: Dexamethasone
Drug: Ropivacaine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05667324
IRB202201279 -A

Details and patient eligibility

About

Maxillary nerve blocks have been shown to significantly reduce post-operative pain and analgesic intake during the 24-hour period following sinus surgery. This randomized, double-blinded, placebo-controlled study will investigate blocks of the pterygopalatine fossa using a suprazygomatic approach during septorhinoplasty surgery. It is the investigator's hypothesis that this technique will result in decreased post-operative pain and opioid use, and the morbidity associated with it.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient presenting for open or endoscopic septorhinoplasty
  • Age 18-80
  • Normal oral food and water intake before surgery
  • ASA physical classification 1-3

Exclusion criteria

  • Refusal to consent
  • Patients without a cellular phone or who are unable to accept text messages
  • Allergy to opioid narcotics
  • ASA physical classification of 4 or higher
  • Patient requires other surgery in addition to septorhinoplasty
  • Age > 80 or <18
  • Any underlying chronic pain condition or ongoing opioid use over the preceding 3 months
  • Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement.
  • Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation.
  • Pregnant women

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Group 1: Ropivacaine plus Dexamethasone
Experimental group
Description:
The group 1 injection procedure will be performed as follows: after preparation of the skin using appropriate skin preparation solution and using aseptic technique, a small-gauge spinal needle will be advanced into the pterygopalatine fossa under ultrasound guidance. Once the needle is properly positioned, 0.5% ropivacaine will be administered at a dose of 20 mg plus 4 mg dexamethasone and the needle will be removed. This procedure will be performed bilaterally
Treatment:
Drug: Ropivacaine
Drug: Dexamethasone
Group 2: Placebo plus Dexamethasone
Active Comparator group
Description:
In group 2 the same procedure will be performed, but the injectate will consist of 5 mL of a balanced crystalloid intravenous solution (4 ml of normal saline) plus 4 mg dexamethasone (each side). This procedure will be performed bilaterally.
Treatment:
Drug: Placebo
Drug: Dexamethasone

Trial contacts and locations

1

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Central trial contact

Jeffrey D Johnson, MD; Cameron R Smith, MD, PhD

Data sourced from clinicaltrials.gov

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