Effect of Bilateral SPG and Infraorbital Nerve Blocks on Recovery After Septorhinoplasty

NCT06929429 | Completed DMC

• 1 other identifier: 2025/23
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, double-blind controlled study aims to compare the effects of bilateral sphenopalatine ganglion and infraorbital nerve blocks on postoperative recovery quality in patients undergoing elective septorhinoplasty under general anesthesia. A total of 90 adult patients (aged 18-65, ASA I-II) will be randomly assigned into two groups: Group 1 will receive bilateral sphenopalatine ganglion block, and Group 2 will receive bilateral infraorbital nerve block. Both blocks will be performed using 4 mL of 0.5% bupivacaine. The primary outcome is the quality of recovery assessed 24 hours after surgery using the QoR-15 questionnaire. Secondary outcomes include intraoperative anesthetic consumption (propofol, remifentanil), emergence agitation (RASS scale), postoperative pain (VAS), need for rescue analgesics (morphine), postoperative nausea and vomiting (VDS), antiemetic consumption (ondansetron), facial edema and hematoma, and length of stay in the post-anesthesia care unit (PACU). All procedures will follow standardized general anesthesia protocols. The study aims to determine which block technique provides superior postoperative recovery, better pain control, fewer side effects, and higher patient satisfaction. No placebo will be used, and no biological samples will be collected.

Conditions

Quality of Recovery (QoR-15); Sphenopalatine Ganglion Block; Infraorbital Nerve Block

Keywords

Septorhinoplasty; Quality of Recovery; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Quality of recovery at postoperative 24 hours

  Postoperative recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The scale contains 15 items covering pain, physical comfort, emotional state, physical independence, and psychological support. Each item is scored from 0 to 10, and the total score ranges from 0 to 150. Higher scores indicate better recovery.

  24 hours postoperatively

Secondary Outcomes (1)

• Pain severity over 24 hours

  1 to 24 hours postoperatively

Study Arms (2)

Sphenopalatine ganglion block

ACTIVE COMPARATOR

Participants in this group will receive a bilateral sphenopalatine ganglion block using 4 mL of 0.5% bupivacaine via intranasal application after induction of general anesthesia and before the start of surgery.

Procedure: Bilateral Sphenopalatine Ganglion Block

Infraorbital Nerve Block

ACTIVE COMPARATOR

Participants in this group will receive a bilateral infraorbital nerve block with 4 mL of 0.5% bupivacaine administered under ultrasound guidance after induction of general anesthesia and before the start of surgery.

Procedure: Bilateral Infraorbital Nerve Block

Interventions

Bilateral Sphenopalatine Ganglion Block PROCEDURE

A bilateral sphenopalatine ganglion block will be performed after induction of general anesthesia using 4 mL of 0.5% bupivacaine. The local anesthetic will be applied intranasally with a cotton-tipped applicator placed parallel to the zygomatic arch and advanced to the posterior nasal cavity. The applicator will remain in place for 15 minutes.

Sphenopalatine ganglion block

Bilateral Infraorbital Nerve Block PROCEDURE

A bilateral infraorbital nerve block will be performed after induction of general anesthesia using 4 mL of 0.5% bupivacaine per side. The block will be guided by linear ultrasound to identify the infraorbital foramen and administered with a 22G needle around the nerve. A 15-minute absorption period will be allowed before the surgical procedure begins.

Infraorbital Nerve Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years
• Scheduled for elective septorhinoplasty under general anesthesia
• ASA physical status I-II
• Able to understand and sign informed consent

You may not qualify if:

• Local infection at the injection site
• History of psychiatric or neurological disorders that impair questionnaire response
• Known coagulopathy
• Allergy to local anesthetics
• History of chronic pain or use of chronic analgesic medication

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study is double-blinded. Neither the participants, the care providers, nor the outcome assessors are aware of group assignments. A separate staff member not involved in the study performs randomization and prepares the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants will be randomly assigned to one of two parallel groups to receive either a bilateral sphenopalatine ganglion block or a bilateral infraorbital nerve block. Each participant will receive only one type of intervention, and the outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: June 19, 2025
• Primary Completion: April 29, 2026
• Study Completion: April 29, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)