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Supraclavicular Brachial Plexus BlockNCT04508894

Ketamine Versus Dexmedetomidine in Supraclavicular Brachial Plexus Block

A study testing Supraclavicular Brachial Plexus Block with bupivacaine, Supraclavicular Brachial Plexus Block with Ketamine and Supraclavicular Brachial Plexus Block with Dexmedetomidine in people with Supraclavicular Brachial Plexus Block, run by Minia University at 1 site in Egypt.

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

Intervention model description: The patients were randomly classified into three groups using computer-generated table numbers each contain (25) patients. Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Supraclavicular Brachial Plexus Block
What is being tested?
Supraclavicular Brachial Plexus Block with bupivacaine, Supraclavicular Brachial Plexus Block with Ketamine and Supraclavicular Brachial Plexus Block with Dexmedetomidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteEgypt
Study dates
21 Apr 2019to 30 Dec 2020
Phase
Interventional
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Physical Status I or II
  • patients undergoing elective and emergency forearm and hand surgeries

Who cannot join

  • Patient with bleeding disorders
  • Damage or disease of the brachial plexus
  • Uncontrolled diabetes mellitus
  • Patients with neuromuscular diseases
  • Patients with a local skin infection at the site of injection
  • Patients with known hypersensitivity to studied drugs

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Minya University

    Minya, 61519

Other trials in Egypt

About this study

Official title: Ketamine Versus Dexmedetomidine as an Adjuvant in Ultrasound-guided Supraclavicular Brachial Plexus Block

Intervention model description: The patients were randomly classified into three groups using computer-generated table numbers each contain (25) patients.

Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine Control group (group C): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. Masking: double-blind (participant and investigator) Masking Description: The investigator's study is a prospective, randomized, double-blind

Read the detailed description

This randomized, prospective, double-blind study was carried out on 75 ASA Physical Status I-II adults aged 18-75 years old scheduled to undergo elective and emergency forearm and hand surgeries under ultrasound-guided supraclavicular brachial plexus block. After obtaining the local ethics committee of El-Minia university hospital approval and written informed consent was taken of the patient, this study was conducted from April 2019 to February 2020 in El-Minia university hospital. The investigators excluded any patient with bleeding disorders, damage or disease of the brachial plexus, uncontrolled diabetes mellitus, and patients with neuromuscular diseases, Patients with a local skin infection at the site of injection or patients with known hypersensitivity to studied drugs.

Preoperative assessment and preparation: A careful assessment of medical history, general examination including chest, heart, abdomen, site of injection and other systems were carried out. Routine investigations were done as complete blood picture, ECG (electrocardiogram) renal and liver functions. An explanation of the visual analog scale was done to each patient.

Preparation of the studied medications: The patients were randomly classified into three groups using computer-generated table numbers each contains (25) patients. Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D) 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine (precedex® Hospira,Inc., Lake Forest USA).

Control group (group C) 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. All medications were prepared in similar sterile coated bottles by the supervisor who didn't include in the anesthetic or operative team, 75 bottles numbered from 1 to 75 were prepared. After completion of the study, the key was opened by the supervisor Block technique: On patient's arrival to the operating room, a 20 G intravenous cannula was inserted in a peripheral vein of unaffected limb and standard monitoring commenced as noninvasive blood pressure (NIBP), (ECG), and Oxygen saturation (Spo2) (UltraviewSL2700, Spacelaps, USA), all equipment and drugs for general anesthesia and resuscitation were prepared, the ultrasound device (Sonosite, Nanomax, USA ) lubricating gel, 21guge 50 mm length, short bevel, insulated stimulating needle (Laboratoires pharmaceutiques, Vygon, France). Patient lie supine with the head turned to the other side and ipsilateral arm adducted gently with a flexed elbow. Under the complete aseptic condition, the identified area and the ultrasound probe was prepared with anti-septic (Povidone-Iodine 10%) solution and the skin infiltrated with 1-2 ml of lidocaine 2% solution subcutaneously, the brachial plexus was visualized by placing the transducer in the sagittal plane in the supraclavicular fossa behind the middle-third of the clavicle. Two distinct appearances of the supraclavicular brachial plexus was seen, it either appeared as a grape-like cluster of 5 to 6 hypoechoic circles, located lateral and superior to the subclavian artery between the anterior and middle scalene muscles at the lower cervical region or as 3 hypoechoic circles with hyperechoic outer rings, the predetermined volume of 40 mL of the study drug solution was administered around the brachial plexus after negative aspiration to avoid accidental intravascular injection, expansion of the brachial plexus sheath was considered as an indication of correct needle placement, multiple injections were used to deposit the total amount of the study drugs, skin massage for about 3 minutes was done to facilitate drug distribution.

Parameters assessed:

  • Hemodynamic data: The hemodynamic variables as HR, MAP and Spo2 were assessed. The parameters were recorded preoperatively just before the block as a baseline value, at 5,10,20,30,60, 90 minutes during the operative time and at 1,2,4,6,9 and 12 hours after the end of the operation.
  • Sensory block was assessed by pinprick test using a 3-point scale [16] Grade 0 = normal sensation, Grade 1 = loss of sensation of pinprick (analgesia), and Grade 2 = loss of sensation of touch (anesthesia).
  • Motor block was determined by thumb abduction (radial nerve), thumb adduction (ulnar nerve), thumb opposition (median nerve), and flexion of elbow (musculocutaneous nerve) according to the modified Bromage 3 point scale: Grade 0: Normal motor function with full flexion and extension of elbow, wrist, and fingers. Grade 1: Decreased motor strength with the ability to move the fingers only. Grade 2: Complete motor block with an inability to move the fingers [16].
  • Onset time for sensory and motor block: the time interval between the end of local anesthetic administration and complete sensory and motor block by min.
  • Sensory block duration: the time interval between the complete sensory block and complete resolution of anesthesia on all the nerves (score 0(
  • Motor block duration: the time interval from complete motor block to complete recovery of motor function of hand and forearm (grade 0) by hours.
  • Visual analog scale (VAS): postoperative, the patients were familiarized with a 10-point visual analog scale (VAS) ranged from 0 = no pain, up to 10 = the worse imaginable pain. VAS was measured at 1, 2, 3, 6, 9, 12 hours. When it equals or >4 the investigators give IM diclofenac sodium (75 mg amp) (Voltaren, Novartis Pharmaceuticals Corporation, Switzerland).
  • Time of first analgesic request: The time passed from supraclavicular brachial plexus block to the patient's first request for analgesic medication by hours
  • Total analgesic requirements in 24 hours) diclofenac consumption)
  • Sedation score: was assessed according to the modified Ramsay Sedation Scale 1987(RSS) from 1-6 as follows: 1 = anxious, agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 = sluggish response to light glabellar tap or loud noise; 6 = no response [17].
  • Adverse effects: any adverse effects such as hypotension (i.e. 20% decrease relative to baseline), bradycardia (HR <60 beats/min), nausea, vomiting, hypoxemia (SpO2 <90%), local hematoma, hemothorax, pneumothorax, recurrent laryngeal nerve block, intravascular injection, Horner's syndrome and signs of local anesthetic toxicity were recorded during the operation and for 12 hours postoperative.
Being tested
Supraclavicular Brachial Plexus Block with bupivacaine, Supraclavicular Brachial Plexus Block with Ketamine, Supraclavicular Brachial Plexus Block with Dexmedetomidine

What participants receive

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

  • Supraclavicular Brachial Plexus Block with bupivacaineDrug

    Also called C group

    drug: 20 ml 0.5%bupivacaine plus 20 ml 0.9% normal saline is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.

    Device: ultrasound-guided supraclavicular Brachial Plexus nerve block

  • Supraclavicular Brachial Plexus Block with KetamineDrug

    Also called K group

    drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1mg\kg ketamine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.

    Device: ultrasound-guided supraclavicular Brachial Plexus nerve block

  • Supraclavicular Brachial Plexus Block with DexmedetomidineDrug

    Also called D group

    drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.

    Device: ultrasound-guided supraclavicular Brachial Plexus nerve block

Study groups in NCT04508894
Study groupRoleWhat they receive
Control groupPlacebo comparatorSupraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline
Receives: Drug: Supraclavicular Brachial Plexus Block with bupivacaine
Ketamine groupActive comparatorSupraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine
Receives: Drug: Supraclavicular Brachial Plexus Block with Ketamine
Dexmedetomidine groupActive comparatorSupraclavicular Brachial Plexus Block using 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine
Receives: Drug: Supraclavicular Brachial Plexus Block with Dexmedetomidine

What is being measured

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

  1. Evaluate duration of sensory block

    Sensory block duration: the time interval between the complete sensory block and complete resolution by hours

    Measured: 24 hours after block

Secondary outcomes (5)
  1. Evaluate onset of sensory and motor block

    Onset time for sensory and motor block: the time interval between the end of local anesthetic administration and complete sensory and motor block by min.

    Measured: 30 minute after block

  2. Assess postoperative pain score

    The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAP) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain

    Measured: For 24 hours after surgery

  3. time to first analgesic request

    Time for the first request to rescue analgesia (in hours)

    Measured: 24 hours

  4. total analgesic requirements

    Total diclofenac consumption requirements in 24 hours

    Measured: 24 hours after surgery

  5. sedation score

    Ramsay Sedation Scale from 1-6 as follows: 1 = anxious, agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 =sluggish response; 6 = no response

    Measured: 24 hours after surgery

Timeline

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

  1. First posted11 Aug 2020
  2. Study start21 Apr 2019
  3. Primary completion28 Dec 2020
  4. Study completion30 Dec 2020

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04508894
Sponsor's protocol ID
146:4/2019
Status last verified
Jul 2023
First submitted
2 Aug 2020
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Supraclavicular Brachial Plexus Block with bupivacaine, Supraclavicular Brachial Plexus Block with Ketamine and Supraclavicular Brachial Plexus Block with Dexmedetomidine in people with Supraclavicular Brachial Plexus Block, run by Minia 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 6 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 1 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 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.

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?

Evaluate duration of sensory block (time frame: 24 hours after block). 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 1 Aug 2023.

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