Supraclavicular Brachial Plexus Block During Upper Limb Surgeries

Brachial Plexus Block Clinical Trial

Official title:

Comparative Study Between Ketamine-Bupivacaine Versus Bupivacaine With Intravenous Ketamine Infusion In Supraclavicular Brachial Plexus Block During Upper Limb Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05315271
• Other study ID #: soh-Med-21-10-07
• Status: Completed
• Phase: Early Phase 1
• Start date: June 1, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: May 2022
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 20, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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 (a2 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	-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).	24 hours