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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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?
None posted in the registry

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.

Sara M Badie, Master degree contact

0109588821

sarabadie1993@gmail.com

Nashwa Nabil, Professor contact

01001111968

nashwanabeel@yahoo.com

Egypt1 site, 1 recruiting
  • Kasr Alainy Teaching Hospitals

    Giza, الجيزة, 1111

    Omnia Y Kamel, MD, 01270130326, omniayehiakamel90@gmail.com

    Sara M Badie, Master

    Recruiting

Other trials in Egypt

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.

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 groups in NCT06633068
Study groupRoleWhat they receive
Group (C) control groupPlacebo comparatorPatients 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 NalbuphineActive comparatorPatients 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.

  1. 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)
  1. Intraoperative hemodynamics

    mean arterial blood pressure

    Measured: every 10 minutes until the end of the surgery

  2. 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.

  3. 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.

  1. First posted9 Oct 2024
  2. Study start15 Jul 2024
  3. Primary completionApr 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

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)
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

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: status not confirmed, 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?

Results are not available in the source record.

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.

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