NCT04006639

Brief Summary

The aim of this study was to compare the efficacy between superficial cervical plexus block and local infiltration of lidocaine 2% in patients undergoing tracheostomy procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

3 months

First QC Date

May 27, 2019

Last Update Submit

December 30, 2019

Conditions

Tracheostomy

Keywords

local infiltrationbilateral superficial cervical plexus blocklidocainebupivacainesubstance-p

Outcome Measures

Primary Outcomes (2)

  • Concentration of substance-P (Baseline)

    Substance-P level is measured as a pain indicator.

    3 months

  • Concentration of substance-P (After Tracheostomy)

    Substance-P level is measured as a pain indicator.

    3 months

Study Arms (2)

Bilateral superficial cervical plexus block with Bupiv

ACTIVE COMPARATOR

Patients, who will have tracheostomy procedure, might receive bilateral superficial cervical plexus block with 10 mL of Bupivacaine 0.5% (20 mL spuit with 25 G 1.5 inch needle) on each side before tracheostomy procedure.

Procedure: Analgesic Technique

Local infiltration of Lidocaine 2%

ACTIVE COMPARATOR

Patients, who will have tracheostomy procedure, might receive local infiltration of Lidocaine 2% (5 mL spuit with 25 G 1.5 inch needle) before tracheostomy procedure.

Procedure: Analgesic Technique

Interventions

Analgesic TechniquePROCEDURE

Patients undergoing tracheostomy procedure must be administered with analgesics, such Lidocaine 20% or Bupivacaine 0.5%

Bilateral superficial cervical plexus block with BupivLocal infiltration of Lidocaine 2%

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physical Status ASA 1-3

You may not qualify if:

  • Pregnant
  • Blood clotting disorder
  • Allergic to anesthetics (Lidocaine, Bupivacaine) used in this study
  • Local infection on procedure area
  • Deformity on procedure area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (7)

  • Pandit JJ, Satya-Krishna R, Gration P. Superficial or deep cervical plexus block for carotid endarterectomy: a systematic review of complications. Br J Anaesth. 2007 Aug;99(2):159-69. doi: 10.1093/bja/aem160. Epub 2007 Jun 18.

    PMID: 17576970RESULT

  • Brandow AM, Wandersee NJ, Dasgupta M, Hoffmann RG, Hillery CA, Stucky CL, Panepinto JA. Substance P is increased in patients with sickle cell disease and associated with haemolysis and hydroxycarbamide use. Br J Haematol. 2016 Oct;175(2):237-245. doi: 10.1111/bjh.14300. Epub 2016 Aug 19.

    PMID: 27539682RESULT

  • Douglas SD. Substance P and sickle cell disease-a marker for pain and novel therapeutic approaches. Br J Haematol. 2016 Oct;175(2):187-188. doi: 10.1111/bjh.14299. Epub 2016 Aug 19. No abstract available.

    PMID: 27539537RESULT

  • De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27.

    PMID: 17588767RESULT

  • Fernandez-Bussy S, Mahajan B, Folch E, Caviedes I, Guerrero J, Majid A. Tracheostomy Tube Placement: Early and Late Complications. J Bronchology Interv Pulmonol. 2015 Oct;22(4):357-64. doi: 10.1097/LBR.0000000000000177.

    PMID: 26348694RESULT

  • Griffiths J, Barber VS, Morgan L, Young JD. Systematic review and meta-analysis of studies of the timing of tracheostomy in adult patients undergoing artificial ventilation. BMJ. 2005 May 28;330(7502):1243. doi: 10.1136/bmj.38467.485671.E0. Epub 2005 May 18.

    PMID: 15901643RESULT

  • Mehta C, Mehta Y. Percutaneous tracheostomy. Ann Card Anaesth. 2017 Jan;20(Supplement):S19-S25. doi: 10.4103/0971-9784.197793.

    PMID: 28074819RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Staff in Department of Anesthesiology and Intensive Care

Study Record Dates

First Submitted

May 27, 2019

First Posted

July 5, 2019

Study Start

August 1, 2019

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)