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

April 30, 2026 updated by: Ömer Keklicek, Konya City Hospital

Comparison of the Effects of Bilateral Sphenopalatine Ganglion and Infraorbital Nerve Blocks on Postoperative Recovery in Patients Undergoing Septorhinoplasty: A Prospective, Randomized, Double-Blind, Controlled Study"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, randomized, double-blind, controlled clinical trial designed to evaluate the effects of two regional anesthesia techniques-bilateral sphenopalatine ganglion block and bilateral infraorbital nerve block-on postoperative recovery quality in adult patients undergoing elective septorhinoplasty under general anesthesia.

A total of 90 patients aged 18-65 years, classified as ASA physical status I-II, will be randomly assigned into two groups using sealed opaque envelope randomization by a non-involved healthcare provider. Group 1 (n=45) will receive bilateral sphenopalatine ganglion blocks with 4 mL of 0.5% bupivacaine applied intranasally using cotton-tipped applicators. Group 2 (n=45) will receive bilateral infraorbital nerve blocks with 4 mL of 0.5% bupivacaine under ultrasound guidance. Both blocks will be performed after anesthesia induction but before the start of surgery.

All patients will undergo standardized general anesthesia using propofol, fentanyl, and rocuronium for induction, followed by maintenance with remifentanil infusion and propofol titration to maintain BIS 40-60. Analgesic medications such as paracetamol, dexketoprofen, and dexamethasone will be administered intraoperatively. At the end of surgery, neuromuscular blockade will be reversed with sugammadex, and patients will be extubated when the TOF ratio exceeds 0.9.

Postoperative assessments include pain severity using the Visual Analog Scale (VAS), agitation level using the Richmond Agitation-Sedation Scale (RASS), and postoperative nausea and vomiting (PONV) using the Verbal Descriptive Scale (VDS). Rescue analgesia (morphine) and antiemetic (ondansetron) use will be recorded. The primary outcome is the quality of recovery measured by the QoR-15 questionnaire at 24 hours postoperatively. Secondary outcomes include intraoperative anesthetic consumption, total opioid requirement within 24 hours, time to first analgesic use, facial edema/hematoma, and PACU discharge time using the Modified Aldrete Score.

All interventions and assessments will be performed by blinded observers, and no placebo or experimental drugs will be used. No biological specimens will be collected.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sphenopalatine ganglion block
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
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.
Active Comparator: Infraorbital Nerve Block
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of recovery at postoperative 24 hours
Time Frame: 24 hours postoperatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain severity over 24 hours
Time Frame: 1 to 24 hours postoperatively
Postoperative pain intensity will be measured using the Visual Analog Scale (VAS) at 1, 2, 6, 12, and 24 hours. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
1 to 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2025

Primary Completion (Actual)

April 29, 2026

Study Completion (Actual)

April 29, 2026

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sphenopalatine Ganglion Block

Clinical Trials on Bilateral Sphenopalatine Ganglion Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe