RecruitingACTRN12623000740695

We aimed to investigate the effects of bilateral sphenopalatine ganglion blockade (SPGB) on postoperative early complications in septorhinoplasty operations.

Randomized Clinical Trial Doubled Blind Study of Bilateral Sphenopalatine ganglion Blockade in Septorhinoplasty Operations


Sponsor

ERHAN GÖKÇEK

Enrollment

80 participants

Start Date

Jul 3, 2023

Study Type

Interventional

Conditions

Summary

The primary aim of our study was to test the hypothesis that SPG blockade provides more analgesia in the first 24 hours postoperatively than the control group in septorhinoplasty operations. In addition, the secondary aim of our study was to investigate the effects of SPG blockade on the ability to further reduce nausea-vomiting, sore throat, and laryngospasm.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Septorhinoplasty is a surgical procedure that corrects the nasal septum (the wall between the nostrils) and reshapes the nose. After this surgery, patients can experience significant pain, as well as unpleasant side effects like nausea, vomiting, and sore throat. This study is testing whether blocking the sphenopalatine ganglion — a small nerve cluster located at the back of the nasal cavity — on both sides can reduce post-operative pain and discomfort more effectively than standard care. The sphenopalatine ganglion block (SPGB) is a simple procedure performed by placing local anaesthetic near the nerve cluster. Participants will be randomly assigned to receive either the nerve block before surgery or standard anaesthesia alone. Pain scores, the need for extra pain medication, and side effects like nausea and vomiting will be assessed for the first 24 hours after surgery. You may be eligible if you are aged 18–50 and are scheduled for an elective septorhinoplasty procedure. People who are pregnant, have known drug allergies relevant to the study, have significant heart or kidney conditions, or are not willing to participate are not eligible.

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Interventions

Sphenopalatine group (Group S, n=40). It was applied with infiltration anesthesia to both groups by the same otolaryngologist with the Sphenocath device(SphenoCath Applicator; Dolor Technologies, Scot

Sphenopalatine group (Group S, n=40). It was applied with infiltration anesthesia to both groups by the same otolaryngologist with the Sphenocath device(SphenoCath Applicator; Dolor Technologies, Scottsdale, Arizona). SPG blockade was performed by a otolaryngologist blinded to the drug used. Patients in group S were performed bilaterally with 2 mL of 0.025% adrenalin-free intranasal bupivacaine (Marcaine 0.5% vial, Astra-Zeneca, Germany) 15 minutes before the end of the operation. The results were evaluated by an anesthesiologist who was not involved in the study. In the recovery unit after the operation; The pain and analgesic needs of the patients at 0, 2, 6 and 24 hours were evaluated. The presence of laryngospasm and the frequency of nausea and vomiting in the first 24 hours were recorded during the recovery period.


Locations(1)

DIYARBAKIR, Turkey

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ACTRN12623000740695