Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-13
SponsorVinícius C Quintão, MD, MSc, PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Sphenopalatine ganglion block (Ropivacaine)
DrugFollowing 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)
DrugFollowing 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.
Treatment groups
145 Participants
are divided into 2 treatment groupsGroup A: Intraoperative sphenopalatine ganglion block with RopivacaineExperimental treatment 1 intervention
Group B: Sham intraoperative sphenopalatine ganglion block with salineSham comparator 1 intervention
Trial outcomes
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.
Time frame
From admission to the PACU until PACU discharge, assessed at admission and every 20 minutes, up to an estimated 60 minutesSecondary outcomes
1
Use of rescue opioids and/or analgesics in the PACU (Post-Anesthesia Care Unit)
Use of rescue opioids and/or analgesics in the PACU (Post-Anesthesia Care Unit): yes or no.
Time frame
From admission to the PACU until PACU discharge, up to an estimated 60 minutes2
Use of rescue opioids and/or analgesics at the time of hospital discharge
Use of rescue opioids and/or analgesics at the time of hospital discharge: yes or no.
Time frame
At hospital discharge, assessed up to an estimated 24 hours after surgery3
Postoperative pain at the time of hospital discharge
Postoperative pain at the time of hospital discharge: yes or no.
Time frame
At hospital discharge, assessed up to an estimated 24 hours after surgery4
Nausea and vomiting in the PACU
Nausea and vomiting in the PACU? yes or no.
Time frame
From admission to the PACU until PACU discharge, up to an estimated 60 minutesLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vinícius C Quintão, MD, MSc, PhD
Lead sponsor
University of Sao Paulo General Hospital
Sponsor institution
University of Sao Paulo General Hospital
Collaborator
Source ClinicalTrials.gov
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