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PainPhase 4NCT05991375

Comparison of Efficacy of Bupivacaine in Supraclavicular Block With or Without Dexmedetomidine

A Phase 4 study testing DEXmedetomidine and saline in people with Pain, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

End-stage renal disease (ESRD) patients are coming for Brachial vein transposition surgery. Patients were randomly allocated using sealed opaque envelope bearing A- (Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and B-Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pain
What is being tested?
DEXmedetomidine and saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 sitePakistan
Study dates
15 Feb 2021to 30 Apr 2021
Phase
Phase 4
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic renal failure patients who will undergo elective basilic vein transposition surgery
  • Either gender
  • ASA III
  • Age 18-65 years.

Who cannot join

  • Mentally challenged
  • Pregnancy.
  • Hypersensitivity to bupivacaine or dexmedetomidine
  • Seizures
  • Neck swelling (hematoma, lipoma, tumor, thyroid)
  • Neuromuscular dystrophy
  • Bleeding disorders

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Syed Muhammad Abbas

    Karachi, Sindh, 74200

Other trials in Pakistan

About this study

Official title: A Randomized Comparative Evaluation Of The Effects Of Dexmedetomidine As An Adjuvant With Bupivacaine In Supraclavicular Block In Chronic Renal Failure Patients Undergoing Basilic Vein Transposition Surgery

End-stage renal disease (ESRD) patients are coming for Brachial vein transposition surgery. Patients were randomly allocated using sealed opaque envelope bearing A- (Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and B-Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml).

Supraclavicular block under ultrasound and nerve stimulator guidance was performed.

Read the detailed description

This study was conducted after approval of the institutional ethical review committee and then from College of Physicians and Surgeons Pakistan. Patients with end stage renal disease (ESRD) coming for Brachial vein transposition surgery, and fulfilling the inclusion criteria were enrolled in this study. All patients were instructed not to consume solid food after midnight prior to surgery. A brief history of demographic data was taken from each patient. Each participant's height in meters was measured using wall mounted scale, weight in kg using a weighing machine, and BMI kg/m² was noted prior to operation. The findings of quantitative variables (age, height, weight, sensory blockade, motor blockade and qualitative variables (gender, diabetes mellitus type II, hypertension, and dyslipidemia) were entered in the proforma attached as an annexure. Patients were randomly allocated using sealed opaque envelope bearing A- (Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and B-Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml). Only the anaesthesiologists for the specific case were aware of the treatment allocation until the end of the surgical procedure. The investigator for assessing the block and the other outcome variables, remained blinded to the patient's group allocation.

Routine monitoring of heart rate \& rhythm by ECG, and arterial blood pressure using non-invasive blood pressure (NIBP) including systolic, diastolic \& mean arterial blood pressure, and peripheral oxygen saturation (SPO2) using a pulse oximeter was performed on each patient. The supraclavicular brachial plexus block was performed under the supervision of a consultant anaesthesiologist in a supine position with a head up to 45 degrees. An Intravenous (IV) line was established and the skin was disinfected and a linear probe, high frequency 12 MHz was placed firmly over the supraclavicular fossa, the probe was positioned in the transverse plane immediately superior to the clavicle at approximately its midpoint. The probe was tilted caudally to obtain a cross sectional view of the subclavian artery. The brachial plexus was seen as a collection of hypo-echoic oval structures lateral and superficial to the artery. Using a 25 gauge needle 1 to 2 ml of 2% lidocaine was locally infiltrated into the skin 1 cm lateral to the probe to decrease the discomfort during needle insertion. A 50 mm or 80 mm length, short bevel, insulated nerve stimulator needle was used. Peripheral nerve stimulation (PNS) is an additional way of confirming nerve location. Initial settings was set at 0.5 mA current, 2 Hz frequency, and pulse width of 0.1 milliseconds. Close approximation to the divisions of brachial plexus was confirmed by getting nerve stimulation on 0.3 mA current. The needle was advanced along the long axis in the same plane as the ultrasound beam. The shaft and tip was visualized in real time as the needle was advanced towards the target nerves. The drug in either group was injected under direct vision of ultrasound beams and by confirming with nerve stimulation. Sensory blockade and motor blockade was assessed every 3 minutes. Time of onset of sensory and motor blockade and duration of sensory and motor blockade were noted as per operational definition. Postoperative pain was assessed with visual analogue scale (VAS). Patients were asked to mark a point on the line that matches the intensity of pain on the Visual Analogue Score hourly for 4 hours post operatively. Those patients having arm pain equal to or greater than 4 on VAS, were given rescue analgesic (inj. Paracetamol (15mg/kg 1/V) and duration of analgesia were noted as per operational definition.

Conditions
Pain
Being tested
DEXmedetomidine, saline
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEXmedetomidineDrug

    Also called DEX

    28 mL of Bupivacain 0.25% was mixed with Dexmedetomidine 1 microgram/kg body weight mixed in 2 mL = total volume 30 mL

  • salineOther

    28 mL of Bupivacain 0.25% was mixed with 2 mL of Normal saline = total volume 30 mL

Study groups in NCT05991375
Study groupRoleWhat they receive
BUPIvacaine 0.25%Active comparator(Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) making a total volume of local anaesthetic solution equal to 30 mL
Receives: Other: saline
Bupivacaine0.25%+DEXExperimentalInjection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml) making a total volume of local anaesthetic solution equal to 30 mL
Receives: Drug: DEXmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score

    Visual Analogue Scale for pain

    0-1-2-3-4-5-6-7-8-9-10

    Pain score 0 means no pain, Pain score 1 to 3 means mild pain, Pain score 4-6 means moderate pain, Pain score 7-9 means severe pain, Pain score 10 means most excruciating pain one can have,

    Measured: 0-4 hours

  2. Heart rate

    Heart rate as per vitals monitoring device

    Measured: 0-4 hours

  3. Mean blood pressure

    as measured by non-invasive blood pressure monitoring device

    Measured: 0-4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start15 Feb 2021
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05991375
Sponsor's protocol ID
SIUT-ERC-2020/PA-257
Status last verified
Aug 2023
First submitted
29 Jul 2023
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DEXmedetomidine and saline in people with Pain, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.

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 4 inclusion and 7 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: finished, as of the sponsor's last update on 14 Aug 2023. 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 Pakistan. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: 0-4 hours). The study lists 3 primary outcomes in all. 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 14 Aug 2023.

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