Nerve Stimulator Versus Ultrasound-guided Infraclavicular Block

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344615
• Other study ID #: ICB1
• Status: Completed
• Phase: N/A
• First received: January 11, 2015
• Last updated: January 27, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Cheju Halla General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided infraclavicular block for upper extremity 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 ultrasound-guided peripheral nerve block enhanced the postoperative analgesia for upper extremity surgery compared with nerve stimulator (NS) guidance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Cheju Halla General Hopsital	Jeju	Jeju self-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. — 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	No
Secondary	block performance time	the time between the block needle insertion and needle withdrawal	at 30 min after block placement	No
Secondary	number of needle redirections	either forward or backward movement of needle at least 1 cm or more	at 30 min after block placement	No
Secondary	patient discomfort	pain score (0-10) during the procedure	at 30 min after block placement	No
Secondary	paresthesia	presence of paresthesia during the procedure	at 30 min after block placement	Yes
Secondary	onset time	complete block of sensory nerve (radial, ulnar, median, musculocutaneous, and medial antebrachial cutaneous nerve)	until 30min after completion of local anesthetic	No
Secondary	motor block of hand	presence of motor block in the operated hand	at 24h after surgery	Yes
Secondary	postoperative dysesthesia	presence of any paresthesia in the operated extremity	at 24h after surgery	Yes
Secondary	supplemental analgesia	Rescue analgesia with 75 mg of IM diclofenac was available on demand.	at 24h after surgery	No
Secondary	Pain score		at 24h after surgery	No
Secondary	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	No