Supraclavicular Brachial Plexus Block During Upper Limb Surgeries

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

Tracking Information

• First Submitted Date: March 8, 2022
• First Posted Date: April 7, 2022
• Last Update Posted Date: May 12, 2022
• Estimated Study Start Date: June 1, 2022
• Estimated Primary Completion Date: June 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Supraclavicular Brachial Plexus Block During Upper Limb Surgeries
• Official Title: 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: Brachial Plexus Block

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 29, 2022): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2023
• Estimated Primary Completion Date: June 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05315271
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Ahmed Gamal Abdelah, Sohag University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sohag University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sohag University
• Verification Date: May 2022