Intra and Postoperative Pain ManagementPhase 2NCT06633068
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.
A Phase 2 study testing Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve block in people with Intra and Postoperative Pain Management, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intra and Postoperative Pain Management
- What is being tested?
- Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to Jul 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 to 60 years old of both sexes undergoing elective thyroid surgery.
- ASA I and II.
Who cannot join
- Patient refusal.
- Hypersensitivity or contraindication to nalbuphine or bupivacaine.
- Pregnancy or lactating mothers.
- Hepatic, cardiac or renal diseases.
- Bleeding disorders.
- Severe neurological or psychological disorders.
- Goitres with retrosternal extension.
- Any anatomical disruption in the neck (ex: metastatic lymph nodes).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy Teaching Hospitals
Giza, الجيزة, 1111
Omnia Y Kamel, MD, 01270130326, omniayehiakamel90@gmail.com
Sara M Badie, Master
About this study
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.
Read the 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.
- Conditions
- Intra and Postoperative Pain Management
- Being tested
- Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve blockDrug
Adding nalbuphine as an adjuvant to bupivacaine in superficial cervical plexus block during thyroid surgeries
| Study group | Role | What they receive |
|---|---|---|
| Group (C) control group | Placebo comparator | Patients will receive bilateral superficial cervical plexus block with 28 ml bupivacine 0.25% mixed with 2 ml saline 0.9%, to a volume of 30 ml, 15 ml on each side of the neck before induction of general anaesthesia. Receives: Drug: Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve block |
| Group (N) Perineural Nalbuphine | Active comparator | Patients will receive bilateral superficial cervical plexus block with 28 ml Bupivacaine 0.25% mixed with 10 mg nalbuphine in saline 0.9% to a volume of 30 ml, 15 ml on each side of the neck before induction of general anaesthesia. Receives: Drug: Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first rescue analgesia (will be given to VAS score > 4) following surgery in the first 24 hours.
defined as the time interval between the end of surgery and the first request to postoperative Nalbuphine
Measured: First 24 hours postoperative
Secondary outcomes (3)
Intraoperative hemodynamics
mean arterial blood pressure
Measured: every 10 minutes until the end of the surgery
VAS score after extubation
Visual Analogue Scale (VAS) measures pain intensity.
Measured: at 0,2,6,12,18 and 24 hours after completion of surgery.
Total amount of nalbuphine administrated to the patient 24 hours postoperative.
As analgesia
Measured: Every one hour postoperative for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start15 Jul 2024
- Primary completionApr 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra and Postoperative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double blinded randomized controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Yahia El Sayed Kamel, Cairo University
- Investigators
- Marwa M Zayed, Assistant professor, Study director, Cairo UniversityAmany Eissa, Doctorate, Study director, Cairo UniversityOmnia Y Kamel, Doctorate degree, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633068
- Sponsor's protocol ID
- Nerve blocks
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06633068
- Acronym / sponsor ID
- Nerve blocks
- Conditions
- Intra and Postoperative Pain Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A double blinded randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Group (C) control group | Placebo comparator | Drug: Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve blockPatients will receive bilateral superficial cervical plexus block with 28 ml bupivacine 0.25% mixed with 2 ml saline 0.9%, to a volume of 30 ml, 15 ml on each side of the neck before induction of general anaesthesia. |
| Group (N) Perineural Nalbuphine | Active comparator | Drug: Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve blockPatients will receive bilateral superficial cervical plexus block with 28 ml Bupivacaine 0.25% mixed with 10 mg nalbuphine in saline 0.9% to a volume of 30 ml, 15 ml on each side of the neck before induction of general anaesthesia. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged between 18 to 60 years old of both sexes undergoing elective thyroid surgery.
- ASA I and II.
Key exclusion criteria (8 listed)
- Patient refusal.
- Hypersensitivity or contraindication to nalbuphine or bupivacaine.
- Pregnancy or lactating mothers.
- Hepatic, cardiac or renal diseases.
- Bleeding disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve blockAdding nalbuphine as an adjuvant to bupivacaine in superficial cervical plexus block during thyroid surgeries | Drug | Group (C) control group, Group (N) Perineural Nalbuphine |
Primary outcome
time to first rescue analgesia (will be given to VAS score > 4) following surgery in the first 24 hours.
Time frame: First 24 hours postoperative
defined as the time interval between the end of surgery and the first request to postoperative Nalbuphine
3 secondary outcomes
Intraoperative hemodynamics
Time frame: every 10 minutes until the end of the surgery
VAS score after extubation
Time frame: at 0,2,6,12,18 and 24 hours after completion of surgery.
Total amount of nalbuphine administrated to the patient 24 hours postoperative.
Time frame: Every one hour postoperative for 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marwa M Zayed, Assistant professor study director
Cairo University
Amany Eissa, Doctorate study director
Cairo University
Omnia Y Kamel, Doctorate degree study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve block in people with Intra and Postoperative Pain Management, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara M Badie, Master degree (0109588821, sarabadie1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first rescue analgesia (will be given to VAS score > 4) following surgery in the first 24 hours. (time frame: First 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.