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Impact of Local Anesthetic Volume During Ultrasound-guided Stellate Ganglion Block

S

Seoul National University

Status

Completed

Conditions

Neuropathic Pain

Treatments

Procedure: Stellate ganglion block

Study type

Interventional

Funder types

Other

Identifiers

NCT03401801
1705-101-856

Details and patient eligibility

About

The purpose of this study was to compare the temperature changes of the upper extremities when using local anesthetic of various volume (4ml, 6ml, 8ml) in the ultrasound guided stellate ganglion block.

Full description

One pain physician performs all US-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure.

For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 4ml, 6ml, and 8ml of 1% lidocaine is injected for the each group, respectively. Syringes are prepared by one nurse who do not involved in other steps of this study.

Temperature measurement is conducted 4 times (before US-guided SGB and after 10, 20, and 30m from SGB) at both hands, face, axillar by one person who's not involved in other measuring in the study.

Enrollment

102 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged 18 to 85 years
  • Patients with a new or known diagnosis of chronic neuropathic pain at the upper extremity or face.

Exclusion criteria

  • Refusal of a patient
  • Any vascular disease in the upper extremities (or face)
  • Previous history of thoracic sympathetic or stellate ganglion neurolysis (e.g. thermocoagulation, radiofrequency neuromodulation, and/or chemical neurolysis)
  • Coagulopathy
  • Systemic infection or local infection at the needle injection site
  • Major deformation at the level of the neck (radiotherapy, surgery, etc.)
  • Concomitant chronic pain syndrome at other sites.
  • Post-pneumonectomy on the controlateral side
  • Known allergy to local anesthetics of amide type
  • Inability to understand a numeric rating pain scale (cognitive dysfunction)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

102 participants in 3 patient groups

4 ml of 1% lidocaine
Active Comparator group
Description:
Procedure: 4 ml of 1% lidocaine is injected for stellate ganglion block using the Ultrasound(US)-guided lateral approach at the sixth cervical vertebral level.
Treatment:
Procedure: Stellate ganglion block
6 ml of 1% lidocaine
Active Comparator group
Description:
Procedure: 6 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level.
Treatment:
Procedure: Stellate ganglion block
8 ml of 1% lidocaine
Active Comparator group
Description:
Procedure: 8 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level.
Treatment:
Procedure: Stellate ganglion block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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