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Supraclavicular Brachial Plexus Block During Upper Limb Surgeries

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ClinicalTrials.gov Identifier: NCT05315271
Recruitment Status : Not yet recruiting
First Posted : April 7, 2022
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
Ahmed Gamal Abdelah, Sohag University

Tracking Information
First Submitted Date  ICMJE March 8, 2022
First Posted Date  ICMJE April 7, 2022
Last Update Posted Date May 12, 2022
Estimated Study Start Date  ICMJE June 1, 2022
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2022)
Comparison of the efficacy of adding ketamine to bupivacaine versus intravenous ketamine infusion with supraclavicular brachial plexus block in upper limb surgeries of sensory block [ Time Frame: 24 hours ]
-Sensory block will be assessed by pin prick test using a 3-point scale : Grade 0 = normal sensation. Grade 1 = loss of sensation of pin prick (analgesia). Grade 2 = loss of sensation of touch (anesthesia).
  • Onset of sensory block: the time interval between the end of local anesthetic administration and complete sensory block by min.
  • Duration of sensory block: the time interval between the complete sensory block and complete resolution of anesthesia.
Intraoperative: sensory block level will be assessed by a pin prick at in the dermatomal areas corresponding to the median, radial, ulnar, and musculocutaneous nerves every 15 minutes at (15 min, 30 min, 45 min ,60 min, Etc.) till end of the operation. Postoperative: will be checked every 30minutes until regain of pinprick sensation at (1/2hr, 1hr, 1.5hr and2hr) then at (3hrs, 6hrs, 12hrs and 24hrs).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supraclavicular Brachial Plexus Block During Upper Limb Surgeries
Official Title  ICMJE Comparative Study Between Ketamine-Bupivacaine Versus Bupivacaine With Intravenous Ketamine Infusion In Supraclavicular Brachial Plexus Block During Upper Limb Surgeries
Brief Summary

Comparative Study Between Ketamine-Bupivacaine Versus Bupivacaine With Intravenous Ketamine Infusion In Supraclavicular Brachial Plexus Block During Upper limb Surgeries The techniques of regional anesthesia have become very popular as they provide several advantages in comparison with general anesthesia and systemic analgesia.

They provide perfect pain control, decreased complications and reduced post-anesthesia care unit stay.

Regional anesthesia provides more patient safety and better outcomes, which leads to the fact that ultrasound-guided regional anesthesia became more popular.

Ultrasound provides clinicians with real-time images which are useful for better identification of the anatomical structures, safe needle placement and adequate local anesthetic spread.

Brachial plexus blocks are commonly achieved via an interscalene, supraclavicular, infraclavicular or axillary approach.

The supraclavicular level is an ideal site to achieve anesthesia of the entire upper extremity just distal to the shoulder as the plexus remains relatively tightly packed at this level, resulting in a rapid and high-quality block. For this reason, the supraclavicular block is often called the ''spinal of the arm'' Using the local anesthetics alone for supraclavicular brachial plexus block provide good operative conditions but have the disadvantage of shorter duration of postoperative analgesia. Various adjuvants such as opioids, dexmedetomidine, dexamethasone, midazolam, ketamine, etc., were added to local anesthetics in brachial plexus block to achieve quick and prolonged block.

Ketamine is a noncompetitive antagonist of the N-methyl-D aspartate receptor(NMDAR).

It is used as a premedication, and for sedation, induction and maintenance of general anesthesia.

Local anesthetic and analgesic properties have been reported for ketamine. Intravenous administration of low-dose ketamine decreases postoperative opioid use and improves analgesia.

Ketamine has been added to bupivacaine to prolong the duration of regional anesthesia and postoperative analgesia.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Brachial Plexus Block
Intervention  ICMJE
  • Drug: Bupivacaine-ketamine injection
    20 ml volume bupivacaine only (0.5%concentration) (with maximum dose not exceeding 4mg/kg ) plus ketamine (1 mg/kg) with maximum dose 100mg ; the total volume is 30 ml with the infusion of 100 ml normal saline at a rate of 100ml/h.
  • Drug: Bupivacaine injection with intravenous ketamine infusion
    20 ml volume bupivacaine only (0.5%concentration) (with maximum dose not exceeding 4mg/kg ) plus 10 ml saline ; the total volume is 30 ml with the infusion of ketamine 0.15 mg/kg added to 100 ml normal saline and will be infused at a rate of 100 ml/h, which will be stopped 5 min before the end of surgery.
Study Arms  ICMJE
  • Active Comparator: Group 1
    All patients will be randomly allocated into two equal groups: each group will contain 30patients:
    Intervention: Drug: Bupivacaine-ketamine injection
  • Active Comparator: Group 2
    All patients will be randomly allocated into two equal groups: each group will contain 30patients:
    Intervention: Drug: Bupivacaine injection with intravenous ketamine infusion
Publications * 1. Abdallah F, Brull R Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth 110(6):915-925,2013. 2. Hanumanthaiah D, Vaidiyanathan S, Garstka M, Szucs S, Iohom G Ultrasound guided supraclavicular block. Med Ultrason 15(3):224-229,2013. 3. Argiriadou KS, McEwen A, Matthew G: Ultrasound-Guided Supraclavicular Brachial Plexus Block https: //www.wfsahq.org/components/com_virtual_library/media/2ffc0a053d75e1cae94f9 3f57cddb8ff-atow-384-00-01.pdf,2018. 4. Swami SS, Keniya VM, Ladi SD, et al. Comparison of dexmedetomidine and clonidine (α2 agonist drugs) as an adjuvant to local anaesthesia in supraclavicular brachial plexus block: a randomised double-blind prospective study. Indian J Anaesth; 56:243-249,2012. 5. Kohli S, Kaur M, Sahoo S, et al. Brachial plexus block: comparison of two different doses of clonidine added to bupivacaine. J Anaesthesiol Clin Pharmacol; 29:491-495, 2013. 6. Reves JG, Glass PS, Lubarsky DA, et al. Intravenous anesthetic. In: Miller R, editor. Miller's anesthesia. 7th ed. Philadelphia: Churchill Livingstone; 724-726, 2010.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2022)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2023
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 75 years.
  • ASA physical status I-II, scheduled.
  • Patients of either sex.
  • Unilateral elective upper limb surgeries undergoing under ultrasound guided supraclavicular brachial plexus block.

Exclusion Criteria:

  • Patient refusal.
  • Patients with peripheral neuropathy of the upper limb.
  • Infection at the injection site.
  • Uncontrolled diabetes, epilepsy, obstructive pulmonary disease and neuromuscular disease.
  • Altered mental status.
  • Hypersensitivity to bupivacaine and ketamine.
  • Patients with coagulopathy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05315271
Other Study ID Numbers  ICMJE soh-Med-21-10-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Ahmed Gamal Abdelah, Sohag University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sohag University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sohag University
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP