Perfusion Index in Detection of Ulnar Nerve Sparing During Supraclavicular Block

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03880201
Collaborator
(none)
51
1
3.3
15.5

Study Details

Study Description

Brief Summary

The aim of this study to evaluate the ability of perfusion index to detect ulnar sparing and to estimate the proper time for the perfusion index ratio to determine successful block.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ultrasound guided supraclavicular block
  • Device: Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA)

Detailed Description

On arrival to the operating room, patients will be connected to standard continuous monitoring; i.e. 5 lead electrocardiography (ECG), pulse oximetry, and automated non-invasive blood pressure monitoring (NIBP) every 5 minute. Two radical-7 (masimo set) devices will be connected the patient through two probes. The probes will be connected to both index and fifth digit to have a baseline reading before block performance. After block performance, PI will be continuously monitored for 30 minutes.

2-Anesthetic technique

Supraclavicular block:
Equipment and preparation:
  • Ultrasound machine with linear transducer (8-14 MHz) (Siemens acusonx300, Korea).

  • 5-cm, 22-gauge insulated block needle

  • Sterile gloves, sterile sleeve, and gel (Or other coupling medium; e.g. Saline)

  • 20 to 25 ml of 0.5% bupivacaine + 2% lidocaine in equal volumes

Patient position:

The block can be performed while the patient is in the supine, semi-sitting, with the Patient's head turned away from the side to be blocked with slight elevation of the head of the bed which is often more comfortable for the Patient and allows for better drainage and less prominence of the neck veins.

Technique:

After sterilization and local anaesthetic infiltration of skin, the linear transducer will be applied firmly above the clavicle in the coronal oblique plane to view the transverse section of the subclavian artery, pleura, first rib and brachial plexus (which is recognized as around or oval compact groups of hypo-echoic nerves, located lateral and superficial to the pulsatile subclavian artery and superior to the first rib). The 22-gauge needle will be inserted at the lateral side of the ultrasound probe using In-plane approach. The block needle will be advanced along the long axis of the transducer (from lateral to medial). The needle will be advanced towards the target nerves inferior, lateral and superficial to subclavian artery respectively. Local anesthetic solution is injected so as to cause hydro dissection of the planes around the plexus the volume of local Anesthetic used is usually between 20 to 25 ml.

Motor block will be assessed as inability to flex elbow and hand joints against gravity and will be tested for each nerve as follow Radial nerve = Push the arm by extending the forearm at the elbow against the resistance, musculocutaneous nerve = Resisting the pull of the forearm at the elbow, median nerve = Thumb and second digit pinch, ulnar nerve = Thumb and fifth digit pinch (15). Sensory block will be assessed by using piece of ice in the distribution of median, ulnar, radial and musculocutaneous nerves. This assessment will take place every 5 minutes till 30 minutes and the block will be considered failed if the patient reports pain at the examined dermatomes during assessment time which needs conversion to general anesthesia. If the patient reports no sensation in the whole upper limb apart from the dermatomes supplied by ulnar nerve, which is not relieved after local infiltration of skin by local anesthetic this will be considered ulnar nerve sparing.

The block assessment will be correlated with Masimo pulse oximetry readings during the first 30 minutes of the block.

Masimo reading of PI values will be recorded every minute (at both index and fifth digits) for 10 minutes then every 3 minutes for 7 readings.

Monitoring of HR, MAP and pulse oximetry will be recorded before the block and every 5 minutes for 30 minutes after the block, then every 15 minutes till the end of surgery.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
51 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Ability of Perfusion Index in Detection of Ulnar Nerve Sparing During Ultra Sound Guided Supraclavicular Block
Actual Study Start Date :
Mar 20, 2019
Actual Primary Completion Date :
Jun 20, 2019
Actual Study Completion Date :
Jun 28, 2019

Arms and Interventions

Arm Intervention/Treatment
patient undergoing upper limb orthopaedic surgery

The study will be performed on patient undergoing upper limb orthopaedic surgery which will be performed under ultrasound guided supraclavicular block.

Procedure: ultrasound guided supraclavicular block
The linear transducer will be applied firmly above the clavicle in the coronal oblique plane the 22-gauge needle will be inserted at the lateral side of the ultrasound probe using In-plane approach. The needle will be advanced towards the target nerves inferior, lateral and superficial to subclavian artery respectively. Local anesthetic solution is injected between 20 to 25 ml. Motor block will be assessed as follow Radial nerve = Push the arm by extending the forearm at the elbow against the resistance, musculocutaneous nerve = Resisting the pull of the forearm at the elbow, median nerve = Thumb and second digit pinch, ulnar nerve = Thumb and fifth digit pinch. Sensory block will be assessed by using piece of ice in the distribution of median, ulnar, radial and musculocutaneous nerves.

Device: Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA)
Masimo reading of PI values will be recorded every minute (at both index and fifth digits) for 20 minutes then every 3 minutes for 30 minutes.

Outcome Measures

Primary Outcome Measures

  1. PI ratio in the little digit [10 minutes after block]

    PI ratio is defined as PI at 10 minutes / PI at the baseline

Secondary Outcome Measures

  1. PI ratio in the index digit [10 minutes after block]

    PI ratio is defined as PI at 10 minutes / PI at the baseline

  2. PI values in the index digit [every minute for 20 minutes then every 3 minutes for 30 minutes]

    PI values is recorded every minute for 20 minutes then every 3 minutes for 30 minutes.

  3. PI values in the little digit [every minute for 20 minutes then every 3 minutes for 30 minutes]

    PI values is recorded every minute for 20 minutes then every 3 minutes for 30 minutes.

  4. Time needed to reach the maximum PI [every minute for 20 minutes then every 3 minutes for 30 minutes.]

    PI values is recorded every minute for 20 minutes then every 3 minutes for 30 minutes.

  5. Time needed to reach the maximum PI ratio [every minute for 20 minutes then every 3 minutes for 30 minutes.]

    PI ratio is calculated as PI at each minute after block / PI at the baseline

  6. Incidence of ulnar nerve sparing [for 30 minutes after block]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Age between 18 and 60 years and weight 60-90 kg.

  • ASA physical status classification I- II

  • Patients scheduled for elective upper limb surgery

Exclusion Criteria:
  • • upper limb ischemia

  • Diabetic neuropathy

  • Known contraindications to regional anaesthetic techniques as coagulopathy.

  • ASA physical status class III-IV.

  • Hypovolemic patients.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university Cairo Egypt 11562

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Ahmed Hasanin, MD, Cairo University
  • Principal Investigator: Bassant abdelhamid, MD, Cairo University
  • Study Director: Mohamed Emam, Master, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bassant M. Abdelhamid, associate professor, Cairo University
ClinicalTrials.gov Identifier:
NCT03880201
Other Study ID Numbers:
  • N-30-2018
First Posted:
Mar 19, 2019
Last Update Posted:
Jul 9, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bassant M. Abdelhamid, associate professor, Cairo University

Study Results

No Results Posted as of Jul 9, 2019