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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06929429
Enrollment
90
Registered
2025-04-16
Start date
2025-06-19
Completion date
2026-06-01
Last updated
2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Septorhinoplasty, Quality of Recovery, Regional Anesthesia

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.

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.

Interventions

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.

PROCEDUREBilateral 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.

Sponsors

Konya City Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of recovery at postoperative 24 hours24 hours postoperativelyPostoperative 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

MeasureTime frameDescription
Pain severity over 24 hours1 to 24 hours postoperativelyPostoperative 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).

Countries

Turkey (Türkiye)

Contacts

Primary ContactOmer Keklicek, Principal Investigator
drokeklicek@gmail.com+90 539 929 17 02

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026