Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy

Sponsor
Vinícius C Quintão, MD, MSc, PhD
Study ID
NCT07793617
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Adenotonsillectomy
  • Postoperative Pain
  • Tonsillectomy

Eligibility Criteria

Sex
ALL
Age
2 Years - 13 Years
Healthy Volunteers
Not accepted

Interventions

  • Sphenopalatine ganglion block (Ropivacaine) — DRUG
    Following induction of general anesthesia and orotracheal intubation, prior to the start of surgery, the study intervention will be performed. The patient will be in a supine position with the neck extended. Extension can be facilitated with a pillow or a folded sheet under both shoulders. A long applicator with a cotton swab at the tip is soaked with ropivacaine 1% anesthetic (maximum dose 10 mg). It is then inserted parallel to the floor of the nose until resistance is felt. The swab will be positioned at the posterior pharyngeal wall superior to the middle turbinate. The applicator will be retained in the nostril for 5-10 minutes and then removed. The procedure is repeated similarly in the other nostril. The swab does not come into direct contact with the ganglion, but the local anesthetic infiltrates the surrounding tissue. The connective tissue and mucous membrane covering the ganglion facilitate the spread and penetration of the drug.
  • Sham sphenopalatine ganglion block (Saline) — DRUG
    Following induction of general anesthesia and orotracheal intubation, prior to the start of surgery, the study intervention will be performed. The patient will be in a supine position with the neck extended. Extension can be facilitated with a pillow or a folded sheet under both shoulders. A long applicator with a cotton swab at the tip is soaked with Saline (sham block). It is then inserted parallel to the floor of the nose until resistance is felt. The swab will be positioned at the posterior pharyngeal wall superior to the middle turbinate. The applicator will be retained in the nostril for 5-10 minutes and then removed. The procedure is repeated in the same manner in the other nostril. The swab does not come into direct contact with the ganglion, but the saline infiltrates the surrounding tissue. The connective tissue and mucous membrane covering it facilitate the spread and penetration of the saline.

Study Details

The aim of this clinical trial is to discover whether sphenopalatine ganglion block (SPGB) reduces postoperative pain in children aged 2 to 13 years undergoing tonsil surgery (with or without adenoid removal). The main questions it aims to answer are: * Does SPGB reduce postoperative pain in children undergoing throat surgery? * Do children who receive SPGB require less pain medication after surgery? * Do children who receive SPGB experience less nausea and vomiting after surgery? * Do children who receive SPGB experience less bleeding during and after surgery? * Do children who received SPGB experience fewer complications after surgery? Researchers will perform SPGB after the child has been placed under general anesthesia, before the surgeon begins the tonsil surgery. Each child will be randomly assigned to receive the SPGB with either a local anesthetic (ropivacaine) or a placebo (saline solution, which looks the same but contains no active medication). This allows researchers to compare pain outcomes between the two groups. To perform the SPGB, a long cotton-tipped applicator soaked in either the anesthetic or the saline solution is gently placed in each of the child's nostrils and left in place for 5-10 minutes before being removed.

Key Dates

First listed
Aug 28, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Aug 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
145 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intraoperative sphenopalatine ganglion block with Ropivacaine
    Intraoperative sphenopalatine ganglion block performed after anesthetic induction and orotracheal intubation, before the start of surgery, with a swab and 1% ropivacaine, maximum 10 mg.
  • Sham Comparator: Sham intraoperative sphenopalatine ganglion block with saline
    Sham intraoperative sphenopalatine ganglion block performed after anesthetic induction and orotracheal intubation, before the start of surgery, with a swab and saline.

Primary Outcome Measure

Incidence of postoperative pain in the Post-Anesthesia Care Unit (PACU) after adenotonsillectomy [ Time Frame: From admission to the PACU until PACU discharge, assessed at admission and every 20 minutes, up to an estimated 60 minutes ]

Central Contacts

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