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OpenTrials
Completed

NCT Number: NCT05667324

Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

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 sphenopalatine ganglion 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.

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Key information

Conditions

Deviated Nasal Septum Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UF Health of University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ropivacaine

Drug

A single injection into the pterygopalatine fossa bilaterally of 0.5% ropivacaine at a dose of 20 mg (each side)

Dexamethasone

Drug

Plus 4 mg dexamethasone

Placebo

Drug

A single injection into the pterygopalatine fossa bilaterally of a balanced crystalloid intravenous solution (4 ml of normal saline)

Primary outcomes

  1. Post Operative Pain Scores

    Time frame: 5 days +/- 2 days

    To assess if bilateral sphenopalatine nerve blocks can decrease post operative pain scores on a scale from 0-10, with a 0 meaning no pain and 10 meaning extreme pain. Pain scores were assessed on post operative days 1, 3 and 5.

Secondary outcomes

  1. Post Anesthesia Care Unit Duration

    Time frame: 60-180 minutes

    To assess if bilateral sphenopalatine nerve blocks results in decreased post-anesthesia care unit observation time (assessed in minutes). Patients are transferred to the post-anesthesia care units immediately following completion of surgery.

  2. Text Message Survey Collection

    Time frame: 5 days post-operatively +/- 1 day

    To assess the efficiency of SMS based survey for post-operative data collection

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Post-operative Pain Control With Sphenopalantine Ganglion Nerve Block in Septorhinoplasty Patients

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 28, 2022
Registry last updated
Apr 27, 2026

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.

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