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Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block

Sponsor
Kafrelsheikh University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06020781
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
4.6
Anticipated Duration (Months)
16.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Our trial aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives in ultrasound-guided supraclavicular brachial plexus block for anesthesia.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence, a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Dexmedetomidine to 20ml Bupivacaine in Supraclavicular Brachial Plexus Block
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bupivacaine and Dexmedetomidine

Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.

Drug: bupivacaine and dexmedetomidine.
patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.
Active Comparator: 20 ml Bupivacaine without additives

Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives.

Drug: bupivacaine only
patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives
Active Comparator: 30 ml bupivacaine without additives

Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.

Drug: bupivacaine
patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.

Outcome Measures

Primary Outcome Measures

  1. Success rate. [30 min after block performance]

    Sensory and motor block evaluation will be done every 3 min after giving the block until complete sensory and motor block or 30 min, whichever will be earlier.

Secondary Outcome Measures

  1. Total pethidine consumption. [24 hours postoperative.]

    Visual analog scale ≥ 4 indicates the analgesic requirements. The patient will be given supplementary pethidine I.V. injection in a dose of 0.5 mg as rescue analgesia. Total pethidine consumption postoperative in the 1st 24 hours will be measured.

  2. Pain score. [24 hours postoperative.]

    Pain score will be measured by visual analogue scale (VAS) at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours postoperative..

  3. Mean arterial blood pressure [From preoperatively till the end of surgery]

    Mean arterial blood pressure from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.

  4. Heart rate [From preoperatively till the end of surgery]

    Heart rate from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.

  5. Postoperative side effects. [24 hours postoperative]

    Complication related to the block or adverse events of the administered drugs.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • American Society of Anesthesiologist (ASA) grade I or II patients

  • both sexes

  • scheduled for elective upper limb surgery below mid-humerus level under Ultrasound -guided Supraclavicular brachial plexus block .

Exclusion Criteria:

  • with pre-existing peripheral neuropathy of upper limb.

  • Bleeding disorders.

  • Infection at injection site.

  • Untreated pneumothorax.

  • Patients on adrenoreceptor agonist or antagonist therapy.

  • History of severe cardiac,.respiratory, hepatic, or renal disease.

  • pregnancy and known hypersensitivity to the study drugs.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kafrelsheikh University Kafr Ash Shaykh Kafrelsheikh Egypt 33516

Sponsors and Collaborators

  • Kafrelsheikh University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gamal Hendawy Shams, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Kafr-El Sheikh University, Kafrelsheikh University
ClinicalTrials.gov Identifier:
NCT06020781
Other Study ID Numbers:
  • KFSIRB200-51
First Posted:
Sep 1, 2023
Last Update Posted:
Sep 1, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dexmedetomidine
Bupivacaine

Study Results

No Results Posted as of Sep 1, 2023