Clinical trial NCT06929429: Effect of Bilateral SPG and Infraorbital Nerve Blocks on Recovery After Septorhinoplasty
Official 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"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Quality of Recovery (QoR-15)
Sphenopalatine Ganglion Block
Infraorbital Nerve Block
Keywords: Septorhinoplasty
Quality of Recovery
Regional Anesthesia
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of recovery at postoperative 24 hours
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Pain severity over 24 hours
timeFrame: 1 to 24 hours postoperatively
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
References: