ClinicalTrials.gg
Status unknownNCT06356415Updated Apr 10, 2024

Infraclavicular Brachial Plexus Block With Bupivacaine Alone or With Both Dexmedetomidine and Dexamethasone

An interventional study of Bupivacaine injection and Bupivacaine+ Dexamethasone+ Dexmedetomidine in Upper Extremity Injury, sponsored by Suez Canal University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. Many medications have been investigated to extend and enhance long-acting local anesthetics' (LA) analgesic effects. Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. In general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects.

Read the detailed description

Brachial plexus blockade-based upper-extremity regional anesthetic approaches have been demonstrated to lessen opioid administration side effects, increase patient satisfaction, and offer noticeably better analgesia right after these surgeries. A lot of drugs have been tested to prolong and improve the analgesic effect of long-acting local anesthetics (LA). Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal, long-lasting single-shot nerve block. Adjuvants have generally been employed in peripheral nerve blocks to lengthen the block effects, limit secondary toxic effects and plasmatic absorption, and speed the onset of the block. Objectives: To compare the effects of adding dexmedetomidine and dexamethasone to bupivacaine on the start of sensory blockade in an infraclavicular brachial plexus block. Patients and Methods: A prospective, randomized controlled trial will be conducted on patients who are undergoing hand or forearm surgeries. Patients who will be eligible for the study will be divided into 2 groups. The first group will receive dexmedetomidine and dexamethasone as adjuvants to bupivacaine, while the second group will receive bupivacaine alone. Expected Results: The success rate, onset time, duration of the block, and possible adverse events.

02

Conditions studied

  • Upper Extremity Injury

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03

In context

Arm Injuries

67 studies on the registry are indexed under Arm Injuries; 10 are open to participants now.

This study's planned enrollment of 40 is below the median of 55 across 48 interventional studies indexed under Arm Injuries.

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Lead sponsor

Suez Canal University is the lead sponsor of 159 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-65 years
  • American Society of Anesthesiologists physical status I-II
  • Body mass index between 18 and 35 kg/ m2
  • scheduled for forearm and hand surgeries

Exclusion criteria

Exclusion Criteria:

  • Inability to consent to the study
  • Coagulopathy
  • Sepsis
  • Decompensated chronic hepatic or renal illnesses
  • Allergy to any of the used drugs
  • Pre-existing musculocutaneous/median/radial/ ulnar neuropathy
  • Prior surgery in the infraclavicular fossa
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Bupivacaine

    Patients will undergo an ultrasound-guided infraclavicular brachial plexus block using bupivacaine alone.

    Drug: Bupivacaine injection

  • Active comparator
    Bupivacaine+ Dexamethasone+ Dexmedetomidine

    Patients will undergo an ultrasound-guided infraclavicular brachial plexus block using bupivacaine combined with dexmedetomidine and dexamethasone.

    Drug: Bupivacaine+ Dexamethasone+ Dexmedetomidine

Interventions

  • Group one will receive infraclavicular block using bupivacaine

  • DrugBupivacaine+ Dexamethasone+ Dexmedetomidine

    Drug pages: Bupivacaine · Dexamethasone · Dexmedetomidine

    Group two will receive infraclavicular block using dexamethasone and dexmedetomidine added to the bupivacaine

06

What researchers measure

Primary outcomes

  1. Onset of sensory block

    Comparing the number of minutes required to achieve total upper limb sensory blockade following the application of an infraclavicular brachial plexus block that includes both dexmedetomidine and dexamethasone in addition to bupivacaine, as opposed to merely using bupivacaine on its own.

    Time frame: Immediately after the performance of the infraclavicular block

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2024; primary completion for Aug 2024, 3 months later.

Of 25 interventional studies with no phase under Arm Injuries, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's planned 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2024
First posted
Apr 10, 2024
StartEst.
May 1, 2024
Primary completionEst.
Aug 30, 2024
CompletionEst.
Sep 30, 2024
Last update
Apr 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06356415
Responsible party
Abdelrhman Alshawadfy (Assistant Professor Suez Canal University Faculty of Medicine, Suez Canal University) — Principal investigator
First posted
Apr 10, 2024
Start date
May 1, 2024 (estimated)
Primary completion
Aug 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Apr 10, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Bupivacaine · Dexamethasone · Dexmedetomidine

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