Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633068
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
The Analgesic Efficacy of Perineural Nalbuphine as an Adjuvant to Bupivacaine in Ultrasound Guided Superficial Cervical Plexus Nerve Block for Thyroid Surgeries A Double Blinded Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Analgesic Efficacy of Perineural Nalbuphine as an Adjuvant to Bupivacaine in Ultrasound Guided Superficial Cervical Plexus Nerve Block for Thyroid Surgeries A Double Blinded Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aiming to evaluate the analgesic effect of adding nalbuphine as an adjuvant to bupivacaine in superficial cervical plexus block during thyroid surgeries regarding first rescue analgesia in the first twenty-four hours postoperative VAS score after extubation and complications such as postoperative nausea vomiting and respiratory depression
Detailed Description:
Thyroidectomy is a common and painful procedure demanding analgesia Patients may experience discomfort in swallowing burning sensation in the throat nausea and vomiting which are all caused by the surgical procedures or general anaesthesia Thyroid surgeries induce brief postoperative pain caused by several mechanisms One of the mechinsims of this Post-operative pain believed to be due to the interruption of the rich nerve supply present in the neck
A lot of drugs have been used to decrease this postoperative pain such as non-steroidal anti inflammatory drugs opioids or regional blocks Traditionally opioids have been the mainstay of postoperative analgesia specifically at thyroid and parathyroid surgical centers where narcotic analgesics make up the major component of their postoperative pain control regimens However the use of opioids has been linked to an increased risk of postoperative complications that include ventilatory depression sedation postoperative nausea and vomiting PONV pruritis difficulty of voiding ileus and surgical site infections which can in turn contribute to delayed hospital discharge Further acute and chronic opioids can have significant effects on the endocrine system Longer-term use of opioids may lead to dependence and substance abuse disorder
The skin overlying the neck ear angle of the mandible shoulder and clavicle is supplied by the superficial cervical plexus SCP which is a sensory neural plexus formed from the ventral rami of the first four cervical nerves C1-C4 It emerges behind the posterior border of sternomastoid muscle
Bilateral superficial cervical plexus block SCPB has shown good intraoperative and postoperative analgesia in upper neck surgeries especially in thyroidectomies this regional block can be facilitated by using ultrasound guided technique as it provides good visualisation of the anatomical structures and decreases the complications
There has always been a search for ideal adjuvants in peripheral nerve blocks which prolong the duration of analgesia with lesser adverse effects Recently nalbuphine was studied frequently as an adjuvant to local anesthetics in spinal and epidural and the results of all studies concluded that nalbuphine is effective when used as an adjuvant to local anaesthetics in spinal and epidural as it significantly prolongs the block duration
The mechanism of perineural nalbuphine has not been clearly identified till now previous studies demonstrated underlying mechanism could be interpreted that inflammatory response increases the synthesis of opioid receptors in the dorsal root ganglion neurons and enhances axonal transport and accumulation of opioid receptors in the sensory nerve endings in the inflamed tissue Moreover nalbuphine is an opioid receptors antagonist that allows for the peripheral analgesic effects of opioids in addition to the analgesic effect of its systemic absorption
However nalbuphine has not been studied extensively as an additive for peripheral nerve blocks as there was a minor research about it as an adjuvant to bupivacaine in brachial plexus block for upper limb surgeries and it showed that it prolongs the duration of sensory and motor blockades and reduces the requirement of analgesics in postoperative period The superficial cervical block is a sensory block carrying sensory nerve fibers only with different axonal chemistry
To our knowledge no study till date compared the analgesic effect of perineural nalbuphine as an adjuvant to the superficial cervical block
A lot of drugs have been used to decrease this postoperative pain such as non-steroidal anti inflammatory drugs opioids or regional blocks Traditionally opioids have been the mainstay of postoperative analgesia specifically at thyroid and parathyroid surgical centers where narcotic analgesics make up the major component of their postoperative pain control regimens However the use of opioids has been linked to an increased risk of postoperative complications that include ventilatory depression sedation postoperative nausea and vomiting PONV pruritis difficulty of voiding ileus and surgical site infections which can in turn contribute to delayed hospital discharge Further acute and chronic opioids can have significant effects on the endocrine system Longer-term use of opioids may lead to dependence and substance abuse disorder
The skin overlying the neck ear angle of the mandible shoulder and clavicle is supplied by the superficial cervical plexus SCP which is a sensory neural plexus formed from the ventral rami of the first four cervical nerves C1-C4 It emerges behind the posterior border of sternomastoid muscle
Bilateral superficial cervical plexus block SCPB has shown good intraoperative and postoperative analgesia in upper neck surgeries especially in thyroidectomies this regional block can be facilitated by using ultrasound guided technique as it provides good visualisation of the anatomical structures and decreases the complications
There has always been a search for ideal adjuvants in peripheral nerve blocks which prolong the duration of analgesia with lesser adverse effects Recently nalbuphine was studied frequently as an adjuvant to local anesthetics in spinal and epidural and the results of all studies concluded that nalbuphine is effective when used as an adjuvant to local anaesthetics in spinal and epidural as it significantly prolongs the block duration
The mechanism of perineural nalbuphine has not been clearly identified till now previous studies demonstrated underlying mechanism could be interpreted that inflammatory response increases the synthesis of opioid receptors in the dorsal root ganglion neurons and enhances axonal transport and accumulation of opioid receptors in the sensory nerve endings in the inflamed tissue Moreover nalbuphine is an opioid receptors antagonist that allows for the peripheral analgesic effects of opioids in addition to the analgesic effect of its systemic absorption
However nalbuphine has not been studied extensively as an additive for peripheral nerve blocks as there was a minor research about it as an adjuvant to bupivacaine in brachial plexus block for upper limb surgeries and it showed that it prolongs the duration of sensory and motor blockades and reduces the requirement of analgesics in postoperative period The superficial cervical block is a sensory block carrying sensory nerve fibers only with different axonal chemistry
To our knowledge no study till date compared the analgesic effect of perineural nalbuphine as an adjuvant to the superficial cervical block
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None