Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359925
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-22
Brief Title:
Suprazygomatic Nerve Block in Tonsillectomy Patients
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Comparative Study Between Dexmedetomidine Plus Bupivacaine Versus Bupivacaine in Suprazygomatic Maxillary Nerve Block for Management of Postoperative Pain in Tonsillectomy Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The use of suprazygomatic maxillary nerve block to reduce postoperative pain and hospital stay is greater than the use of NSAID and opioids
Detailed Description:
Tonsillectomy is one of the most commonly performed operations worldwide with postoperative pain being the main cause of morbidity Unlike most other surgeries tonsillectomies leave an open wound that heals by secondary intention Thermal and mechanical injuries lead to inflammation nerve irritation and spasms of the pharyngeal muscles that can result in severe pain Because this procedure is performed primarily on an outpatient basis postoperative complications including pain vomiting fever and hemorrhage can significantly lengthen recovery room stays and lead to emergency department visits and unanticipated hospital admission
Poorly controlled posttonsillectomy pain can result in decreased oral intake dysphagia dehydration and weight loss Standard management of postoperative pain following tonsillectomy includes acetaminophen hydrocodone or oxycodone and nonsteroidal anti-inflammatory drugs
Despite scheduled administration of analgesics postoperative pain is often poorly controlled
Opioid use and preoperative pain at or remote from the surgical site have been demonstrated to be associated with a higher risk of persistent postoperative pain and large cohort studies have reported concerning rates of long-term postoperative opioid use after minor surgery in previously opioid-naıve patients
Efforts to reduce opioid use particularly after hospital discharge require further attention thus opioid consumption beyond the early postoperative period is an increasingly important outcome measure
As systemic analgesics have proven inefficacious and insufficient to reliably control post-tonsillectomy pain regional anesthetic techniques are an option and although they are in their infancy in terms of development and rarely utilized they may offer advantages over standard approaches The tonsils are innervated both by branches of the maxillary division of the trigeminal nerve via the lesser and perhaps greater palatine nerves and the tonsillar branches of the glossopharyngeal nerve whereas the adenoids are innervated exclusively by branches of the lesser palatine nerve Although some studies have indicated significant reduction of postoperative pain with both pre-incisional ropivacaine injected into the tonsillar fossa and postincisional topical ropivacaine in the tonsillar fossa a Cochrane review of local anesthetics to reduce post-tonsillectomy pain found no evidence of efficacy
Given the insufficient evidence and risk of inadvertent injection into the carotid artery the use of local anesthetics at the surgical site is not currently recommended
Local anesthetic injected into the pterygopalatine fossa has been described for pediatric cleft palate repair with excellent control of postoperative pain compared with systemic analgesics
The need for postoperative morphine was completely eradicated in one study The effects of local anesthetic have been noted to have effects on pain for an inexplicably long period up to 10 days after injection long after the local anesthetic wears off The tonsillar bed is innervated by the lesser and perhaps greater palatine nerve and the glossopharyngeal nerve Given that both the greater and lesser palatine nerves originate in the pterygopalatine fossa this space is a logical anatomic target for regional anesthesia to cover the tonsillar fossa Targeting of the glossopharyngeal nerve for blockade while possible would also ablate the gag reflex which carries an unacceptably high risk of airway compromise in the aftermath of pharyngeal surgery The suprazygomatic approach to the pterygopalatine fossa is a technically easy procedure to perform with ultrasound guidance with an average procedure time of 56 seconds Suprazygomatic approaches to the pterygopalatine fossa have been associated with fewer complications than infrazygomatic approaches which include orbital puncture intracranial injection maxillary artery puncture or posterior pharyngeal wall injury
Using a suprazygomatic approach and ultrasound guidance Sola et al experienced zero technical complications after 50 blocks
Poorly controlled posttonsillectomy pain can result in decreased oral intake dysphagia dehydration and weight loss Standard management of postoperative pain following tonsillectomy includes acetaminophen hydrocodone or oxycodone and nonsteroidal anti-inflammatory drugs
Despite scheduled administration of analgesics postoperative pain is often poorly controlled
Opioid use and preoperative pain at or remote from the surgical site have been demonstrated to be associated with a higher risk of persistent postoperative pain and large cohort studies have reported concerning rates of long-term postoperative opioid use after minor surgery in previously opioid-naıve patients
Efforts to reduce opioid use particularly after hospital discharge require further attention thus opioid consumption beyond the early postoperative period is an increasingly important outcome measure
As systemic analgesics have proven inefficacious and insufficient to reliably control post-tonsillectomy pain regional anesthetic techniques are an option and although they are in their infancy in terms of development and rarely utilized they may offer advantages over standard approaches The tonsils are innervated both by branches of the maxillary division of the trigeminal nerve via the lesser and perhaps greater palatine nerves and the tonsillar branches of the glossopharyngeal nerve whereas the adenoids are innervated exclusively by branches of the lesser palatine nerve Although some studies have indicated significant reduction of postoperative pain with both pre-incisional ropivacaine injected into the tonsillar fossa and postincisional topical ropivacaine in the tonsillar fossa a Cochrane review of local anesthetics to reduce post-tonsillectomy pain found no evidence of efficacy
Given the insufficient evidence and risk of inadvertent injection into the carotid artery the use of local anesthetics at the surgical site is not currently recommended
Local anesthetic injected into the pterygopalatine fossa has been described for pediatric cleft palate repair with excellent control of postoperative pain compared with systemic analgesics
The need for postoperative morphine was completely eradicated in one study The effects of local anesthetic have been noted to have effects on pain for an inexplicably long period up to 10 days after injection long after the local anesthetic wears off The tonsillar bed is innervated by the lesser and perhaps greater palatine nerve and the glossopharyngeal nerve Given that both the greater and lesser palatine nerves originate in the pterygopalatine fossa this space is a logical anatomic target for regional anesthesia to cover the tonsillar fossa Targeting of the glossopharyngeal nerve for blockade while possible would also ablate the gag reflex which carries an unacceptably high risk of airway compromise in the aftermath of pharyngeal surgery The suprazygomatic approach to the pterygopalatine fossa is a technically easy procedure to perform with ultrasound guidance with an average procedure time of 56 seconds Suprazygomatic approaches to the pterygopalatine fossa have been associated with fewer complications than infrazygomatic approaches which include orbital puncture intracranial injection maxillary artery puncture or posterior pharyngeal wall injury
Using a suprazygomatic approach and ultrasound guidance Sola et al experienced zero technical complications after 50 blocks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None