Completed

NCT Number: NCT05315271

Supraclavicular Brachial Plexus Block During Upper Limb Surgeries

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.

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Key information

Conditions

Brachial Plexus Block

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Sohag University

Sohag, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine-ketamine injection

Drug

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

Drug

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.

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Apr 7, 2022
Registry last updated: Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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