Nerve Stimulator Versus Ultrasound-guided Infraclavicular Block

A Randomized Comparison of Nerve Stimulator and Ultrasound-guided Infraclavicular Block for Upper Extremity Surgery

The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided infraclavicular block for upper extremity surgery.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: NS-guided infraclavicular block; Procedure: US-guided infraclavicular block

Detailed Description

Ultrasound (US)-guided peripheral nerve block has increased in popularity. It has many advantages such as improved success rate, faster onset time, fewer needle passes, shorter performance time, and reduced procedural pain and vascular puncture. However, there is no information about postoperative analgesia.

Therefore, the investigators tested whether ultrasound-guided peripheral nerve block enhanced the postoperative analgesia for upper extremity surgery compared with nerve stimulator (NS) guidance.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeju self-governing province
    • Jeju, Jeju self-governing province, Korea, Republic of, 670-744
      • Cheju Halla General Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologists physical class I - III patients scheduled to undergo upper extremity surgery

Exclusion Criteria:

• coagulopathy, severe pulmonary disease, neuropathy, contralateral diaphragmatic paresis, allergy to study medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NS-guided infraclavicular block; NS-guided infraclavicular block is performed using 35 ml of 0.5% ropivacaine.	Procedure: NS-guided infraclavicular block; Patients received a standard single injection infraclavicular block using the lateral sagittal approach of Klaastad. The infraclavicular brachial plexus is identified using an insulated needle connected to a nerve stimulator. Placement of the needle is considered adequate if motor response of radial nerve in the hand or wrist is still present at 0.2 - 0.5mA. Ropivacaine 0.5% 35ml is used.
Experimental: US-guided infraclavicular block; US-guided infraclavicular block is performed using 35 ml of 0.5% ropivacaine.	Procedure: US-guided infraclavicular block; Infraclavicular block is performed under ultrasound guidance. Linear probe is placed in a parasagittal positon below the clavicle medial to the coracoid process and adjusted to achieve a cross-sectional image of the axillary artery. Using in-plane technique, an 22-gauge insulated needle is advanced caudally and posteriorly to the axillary artery. Subsequently, 35 ml of 0.5% ropivacaine is incrementally injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative analgesia	time from completion of local anesthetic injection until the first request for an analgesic	at 24h after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
block performance time	the time between the block needle insertion and needle withdrawal	at 30 min after block placement
number of needle redirections	either forward or backward movement of needle at least 1 cm or more	at 30 min after block placement
patient discomfort	pain score (0-10) during the procedure	at 30 min after block placement
paresthesia	presence of paresthesia during the procedure	at 30 min after block placement
onset time	complete block of sensory nerve (radial, ulnar, median, musculocutaneous, and medial antebrachial cutaneous nerve)	until 30min after completion of local anesthetic
motor block of hand	presence of motor block in the operated hand	at 24h after surgery
postoperative dysesthesia	presence of any paresthesia in the operated extremity	at 24h after surgery
supplemental analgesia	Rescue analgesia with 75 mg of IM diclofenac was available on demand.	at 24h after surgery
Pain score		at 24h after surgery
Patient satisfaction	The acceptance of the anesthetic technique was evaluated using a two-point score: 1, satisfactory (if necessary, I would have the same anesthetic technique); and 2, unsatisfactory (different anesthetic technique).	at 24h after surgery

Collaborators and Investigators

• Sponsor: Cheju Halla General Hospital
• Investigators: Principal Investigator: Chunwoo Yang, MD, Dept. of anesthesia and pain medicine, Cheju Halla General Hospital

Publications and helpful links

General Publications

• Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.
• Koscielniak-Nielsen ZJ. Ultrasound-guided peripheral nerve blocks: what are the benefits? Acta Anaesthesiol Scand. 2008 Jul;52(6):727-37. doi: 10.1111/j.1399-6576.2008.01666.x. Epub 2008 May 12.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 11, 2015
• First Submitted That Met QC Criteria: January 18, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: ultrasound; nerve stimulator
• Other Study ID Numbers: ICB1