Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

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)

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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