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NCT Number: NCT06929429

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya City Hospital

Konya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

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"

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2025
Registry last updated
May 6, 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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