Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy

NCT07793617 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: SPARK
• Study Type: interventional
• Target: 145
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain; Tonsillectomy; Adenotonsillectomy

Keywords

sphenopalatine ganglion block; Pediatric anesthesia; Postoperative pain management; Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative pain in the Post-Anesthesia Care Unit (PACU) after adenotonsillectomy

  Comparison of the incidence of immediate postoperative pain in the PACU between children who received sphenopalatine ganglion block (SPGB) with ropivacaine 1% and children who received sham block (0.9% NaCl). Pain will be measured using the highest pain score recorded in the PACU, using an age-appropriate scale: * \< 4 years: Revised FLACC Scale * \> 4 and \< 6 years: Revised FACES Scale * ≥ 6 years: Numeric Rating Scale (NRS) A score ≥ 4 on any of these scales will be considered as presence of pain. The analysis will compare the proportion of patients with pain (score ≥4) between the two groups, with estimation of the risk difference and 95% confidence interval.

  From admission to the PACU until PACU discharge, assessed at admission and every 20 minutes, up to an estimated 60 minutes

Secondary Outcomes (13)

• Use of rescue opioids and/or analgesics in the PACU (Post-Anesthesia Care Unit)

  From admission to the PACU until PACU discharge, up to an estimated 60 minutes

• Use of rescue opioids and/or analgesics at the time of hospital discharge

  At hospital discharge, assessed up to an estimated 24 hours after surgery

• Postoperative pain at the time of hospital discharge

  At hospital discharge, assessed up to an estimated 24 hours after surgery

• Nausea and vomiting in the PACU

  From admission to the PACU until PACU discharge, up to an estimated 60 minutes

• Nausea and vomiting at the time of hospital discharge

  At hospital discharge, assessed up to an estimated 24 hours after surgery

Study Arms (2)

Intraoperative sphenopalatine ganglion block with Ropivacaine

EXPERIMENTAL

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.

Drug: Sphenopalatine ganglion block (Ropivacaine)

Sham intraoperative sphenopalatine ganglion block with saline

SHAM COMPARATOR

Sham intraoperative sphenopalatine ganglion block performed after anesthetic induction and orotracheal intubation, before the start of surgery, with a swab and saline.

Drug: Sham sphenopalatine ganglion block (Saline)

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.

Intraoperative sphenopalatine ganglion block with Ropivacaine

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.

Sham intraoperative sphenopalatine ganglion block with saline

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2 to 13 years admitted for tonsillectomy/tonsillotomy with or without adenoidectomy;
• Patients classified as Physical Status I and II according to the American Society of Anesthesiologists (ASA);
• Otolaryngologists responsible for the patient according to the study and willing to report the data necessary for this study.

You may not qualify if:

• Children with hypersensitivity or allergy to the drugs used in the study protocol for AG and/or BGEP;
• Use of concomitant medications for anesthesia or pain control that are not in the study protocol in the pre or intraoperative period;
• Children with a history of chronic orofacial pain;
• Failure to provide written Informed Consent Form (ICF) or Informed Assent form (IAF) to participate in the study.

Sponsors & Collaborators

• Vinícius C Quintão, MD, MSc, PhD: lead
• University of Sao Paulo General Hospital: collaborator

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sphenopalatine Ganglion Block; Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Vinicius C Quintao, MD, MSc, PhD Investigator

  Hospital das clinicas da Universidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinicius C Quintao, MD, MSc, PhD Investigator

CONTACT

+ 55 11 971273950; vinicius.quintao@fm.usp.br

Claudia L F Horiguchi, Local Investigator

CONTACT

+ 55 31 984788884; claudialeal.anestesia@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and their legal guardians are blinded to group allocation. Anesthesiologists, surgeons, and PACU staff responsible for postoperative assessments are blinded. Only one designated unblinded team member prepares the study medication (ropivacaine or saline) according to the randomization result, based on a web-based block randomization list managed by an external person.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Anesthesiologist

Model Details: Participants will be randomized 1:1 into two parallel groups: the intervention group (sphenopalatine ganglion block with ropivacaine 1%) and the control group (sham block with 0.9% NaCl).

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share