Nerve Stimulator Versus Ultrasound-guided Interscalene Block for Shoulder Surgery

A Randomized Comparison of Nerve Stimulator-guided and Ultrasound-guided Interscalene Block for Shoulder Surgery

The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided interscalene block after shoulder surgery.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: NS-guided interscalene block; Procedure: US-guided interscalene 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 nerve stimulator (NS) - guided interscalene block was inferior to ultrasound-guided block in terms of duration of postoperative analgesia for shoulder surgery.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeju special governing province
    • Jeju-si, Jeju special 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 shoulder 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: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NS-guided interscalene block; NS-guided interscalene block is performed using 20 ml of 0.75% ropivacaine.	Procedure: NS-guided interscalene block; Patients received a standard single injection interscalene block using the modified lateral approach of Borgeat. The interscalene brachial plexus was identified using an insulated needle connected to a nerve stimulator. An insulated needle attached to a nerve stimulator was used to identify the brachial plexus. Placement of the needle was considered adequate if the deltoid, triceps, pectoralis, or biceps muscle motor response was still present at 0.2 - 0.5mA. Ropivacine 0.75% 20ml was used.
Experimental: US-guided interscalene block; US-guided interscalene block is performed using 20 ml of 0.75% ropivacaine.	Procedure: US-guided interscalene block; Interscalene block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral interscalene groove visualizing the brachial plexus located between anterior and middle scalene muscles. Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.75% ropivacaine is 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
onset time (complete block of sensory and motor nerve)	complete block of sensory and motor nerve	until 30min after completion of local anesthetic
patient discomfort (pain score (0 -10) during the procedure)	pain score (0 -10) during the procedure	at 30 min after block placement
block performance time (the time between the block needle insertion and needle withdrawal)	the time between the block needle insertion and needle withdrawal.	at 30 min after block placement
The number of needle redirections	either forward or backward movement of needle at least 1 cm or more	at 30 min after block placement
paresthesia (presence of paresthesia during the procedure)	presence of paresthesia during the procedure	at 30 min after block placement
motor block of hand	degree of motor block in the operated hand	at 30 min after block placement
paresthesia of hand	presence of paresthesia in the operated hand	at 30 min after block placement
Supplemental analgesia		at 24h after surgery
Pain score	numerical rating scale (0 - 10)	at 24h after surgery
Patient satisfaction	Patient satisfaction 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, Dep. 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: March 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: ultrasound; nerve stimulator
• Other Study ID Numbers: inter2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES