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CompletedNCT04508894Updated Aug 1, 2023

Ketamine Versus Dexmedetomidine in Supraclavicular Brachial Plexus Block

An interventional study of Supraclavicular Brachial Plexus Block with bupivacaine and Supraclavicular Brachial Plexus Block with Ketamine in Supraclavicular Brachial Plexus Block, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Apr 2019, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Supraclavicular Brachial Plexus Block
03

In context

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
75 participants (actual)

Study arms

  • Placebo comparator
    Control group

    Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline

    Drug: Supraclavicular Brachial Plexus Block with bupivacaine

  • Active comparator
    Ketamine group

    Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\\kg ketamine

    Drug: Supraclavicular Brachial Plexus Block with Ketamine

  • Active comparator
    Dexmedetomidine group

    Supraclavicular Brachial Plexus Block using 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\\kg dexmedetomidine

    Drug: Supraclavicular Brachial Plexus Block with Dexmedetomidine

Interventions

  • DrugSupraclavicular Brachial Plexus Block with bupivacaine

    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

    Also known as: C group

  • DrugSupraclavicular Brachial Plexus Block with Ketamine

    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

    Also known as: K group

  • DrugSupraclavicular Brachial Plexus Block with Dexmedetomidine

    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

    Also known as: D group

06

What researchers measure

Primary outcomes

  1. Evaluate duration of sensory block

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

    Time frame: 24 hours after block

Secondary outcomes

  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.

    Time frame: 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

    Time frame: For 24 hours after surgery

  3. time to first analgesic request

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

    Time frame: 24 hours

  4. total analgesic requirements

    Total diclofenac consumption requirements in 24 hours

    Time frame: 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

    Time frame: 24 hours after surgery

07

Study locations

1 site
  • Minya University
    Minya, 61519, Egypt
08

References and documents

Study documents

  • Study protocol · Feb 21, 2019

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04508894
Lead sponsor
Minia University
Responsible party
haidy salah mansour (Professor, Minia University) — Principal investigator
First posted
Aug 11, 2020
Start date
Apr 21, 2019
Primary completion
Dec 28, 2020
Completion
Dec 30, 2020
Last update
Aug 1, 2023

Study contacts

Haidy S Mansour, MD
principal investigator · assistant professor of Anesthesia and Surgical Intensive Care

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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