Adenotonsillectomy, Postoperative Pain, Tonsillectomy
Conditions
Keywords
sphenopalatine ganglion block, Pediatric anesthesia, Postoperative pain management, Regional anesthesia
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.
Detailed description
Tonsillectomy, with or without adenoidectomy, is one of the most common surgical procedures performed in children. Despite being frequent, it is associated with significant postoperative morbidity, particularly severe pain, postoperative nausea and vomiting, and bleeding. Current pain management relies heavily on opioids and nonsteroidal anti-inflammatory drugs, both of which carry risks in this population: opioids are associated with respiratory depression, of particular concern in children with obstructive sleep apnea, and increased postoperative nausea and vomiting, while NSAIDs raise concerns about postoperative bleeding. The sphenopalatine ganglion block is a simple, minimally invasive technique that has shown promising analgesic effects in adults undergoing sinonasal and other otorhinolaryngologic surgeries, with evidence suggesting reduced postoperative pain, reduced opioid consumption, and reduced intraoperative bleeding. However, evidence supporting the safe and effective use of sphenopalatine ganglion block specifically in children undergoing adenotonsillectomy remains limited. This study is designed to evaluate whether sphenopalatine ganglion block reduces postoperative pain compared with a sham block in children undergoing tonsillectomy or tonsillotomy, with or without adenoidectomy, for indications such as obstructive sleep apnea or recurrent tonsillitis. Eligible participants will be randomized 1:1 using a web-based block randomization system managed by a person external to the clinical team. An unblinded team member, not otherwise involved in the child's anesthetic or surgical care, will prepare the study medication (ropivacaine or saline) according to the randomization result. All other members of the clinical and research team, as well as the participants and their families, will remain blinded to group allocation. Based on an alpha of 0.05, a statistical power of 95%, and a medium effect size (Cramer's V = 0.3 for the chi-square test; d = 0.6 for the Mann-Whitney test), a total sample size of 145 participants was determined to provide adequate power for both the primary and key secondary outcomes. This is the first randomized clinical trial to evaluate the effect of sphenopalatine ganglion block specifically on postoperative pain control after adenotonsillectomy in children, and its findings are intended to help inform evidence-based perioperative pain management guidelines for this common pediatric surgical population.
Interventions
DRUGSphenopalatine ganglion block (Ropivacaine)
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.
DRUGSham sphenopalatine ganglion block (Saline)
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.
Sponsors
Vinícius C Quintão, MD, MSc, PhD
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
2 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative pain in the Post-Anesthesia Care Unit (PACU) after adenotonsillectomy | From admission to the PACU until PACU discharge, assessed at admission and every 20 minutes, up to an estimated 60 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of rescue antiemetics at the time of hospital discharge | At hospital discharge, assessed up to an estimated 24 hours after surgery | Consumption of rescue antiemetics at the time of hospital discharge: yes or no. |
| Intraoperative bleeding | Assessed intraoperatively, at the end of the surgical procedure | Surgeon's opinion on perioperative bleeding: very reduced, reduced, usual, increased, or very increased. |
| Postoperative bleeding | From the end of surgery up to 30 days after surgery | Postoperative bleeding: yes or no The surgeon will inform you if bleeding resulting from the surgical procedure occurs up to 30 days after the surgery. |
| Surgical reintervention | From the end of surgery up to 30 days after surgery | Surgical reintervention: yes or no Need for surgical re-intervention. |
| Medical consultations outside the scheduled | From the end of surgery up to 30 days after surgery | Medical consultations outside the scheduled postoperative control due to complications within the first 30 days of surgery: 1. Consultations only. 2. Readmission for observation. 12. Critical perioperative respiratory events: laryngospasm, stridor, bronchial aspiration, hypoxia (O2 saturation \< 90% for 2 minutes), use of supplemental oxygen in the PACU. |
| Morbidity in the first 30 days after surgery | From the end of surgery up to 30 days after surgery | Morbidity in the first 30 days after surgery: admission to intensive care unit or ICU, readmission due to: NGO infection, dehydration, pulmonary infection, pulmonary complications, seizure. |
| Mortality in the first 30 days after surgery | From the end of surgery up to 30 days after surgery | Mortality: yes or no |
| Nausea and vomiting in the PACU | From admission to the PACU until PACU discharge, up to an estimated 60 minutes | Nausea and vomiting in the PACU? yes or no. |
| Nausea and vomiting at the time of hospital discharge | At hospital discharge, assessed up to an estimated 24 hours after surgery | Nausea and vomiting at the time of hospital discharge: yes or no. |
| 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 in the PACU (Post-Anesthesia Care Unit): yes or no. |
| 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 | Use of rescue opioids and/or analgesics at the time of hospital discharge: yes or no. |
| Consumption of rescue antiemetics in the PACU | From admission to the PACU until PACU discharge, up to an estimated 60 minutes | Consumption of rescue antiemetics in the PACU: yes or no. |
| Postoperative pain 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: yes or no. |
Contacts
CONTACTVinicius C Quintao, MD, MSc, PhD Investigator
CONTACTClaudia L F Horiguchi, Local Investigator
PRINCIPAL_INVESTIGATORVinicius C Quintao, MD, MSc, PhD Investigator
Hospital das clinicas da Universidade de Sao Paulo
Outcome results
None listed