Supraclavicular Brachial Plexus Block During Upper Limb Surgeries

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05315271
Collaborator
(none)
60
2
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine-ketamine injection
  • Drug: Bupivacaine injection with intravenous ketamine infusion
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Comparative Study Between Ketamine-Bupivacaine Versus Bupivacaine With Intravenous Ketamine Infusion In Supraclavicular Brachial Plexus Block During Upper Limb Surgeries
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1

All patients will be randomly allocated into two equal groups: each group will contain 30patients:

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.

Active Comparator: Group 2

All patients will be randomly allocated into two equal groups: each group will contain 30patients:

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.

Outcome Measures

Primary Outcome Measures

  1. 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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Gamal Abdelah, Resident of Anesthesiology , Intensive care unit and Pain management., Sohag University
ClinicalTrials.gov Identifier:
NCT05315271
Other Study ID Numbers:
  • soh-Med-21-10-07
First Posted:
Apr 7, 2022
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed Gamal Abdelah, Resident of Anesthesiology , Intensive care unit and Pain management., Sohag University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2022