Nerve Stimulator Versus Ultrasound-guided Interscalene Block for Shoulder Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342873
• Other study ID #: inter2
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: July 13, 2017
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2017
• Source: Cheju Halla General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
Korea, Republic of	Cheju Halla General Hopsital	Jeju-si	Jeju special governing province

Sponsors (1)

Lead Sponsor	Collaborator
Cheju Halla General Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of postoperative analgesia	time from completion of local anesthetic injection until the first request for an analgesic	at 24h after surgery
Secondary	onset time (complete block of sensory and motor nerve)	complete block of sensory and motor nerve	until 30min after completion of local anesthetic
Secondary	patient discomfort (pain score (0 -10) during the procedure)	pain score (0 -10) during the procedure	at 30 min after block placement
Secondary	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
Secondary	The number of needle redirections	either forward or backward movement of needle at least 1 cm or more	at 30 min after block placement
Secondary	paresthesia (presence of paresthesia during the procedure)	presence of paresthesia during the procedure	at 30 min after block placement
Secondary	motor block of hand	degree of motor block in the operated hand	at 30 min after block placement
Secondary	paresthesia of hand	presence of paresthesia in the operated hand	at 30 min after block placement
Secondary	Supplemental analgesia		at 24h after surgery
Secondary	Pain score	numerical rating scale (0 - 10)	at 24h after surgery
Secondary	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