- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04006639
Efficacy of Bilateral Superficial Cervical Plexus Block vs. Local Infiltration of Lidocaine 2% in Tracheostomy Procedure
Comparison of Efficacy Between Bilateral Superficial Cervical Plexus Block and Local Infiltration of Lidocaine 2% in Patients Undergoing Tracheostomy
Study Overview
Detailed Description
Ethical approval was obtained from Ethics Committee of Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo Hospital.
Eligible subjects for this study will be recruited with consecutive sampling method within certain period until minimum number of subjects required for this study is filled.
Informed consents will be given to each subject before participating in the study. Patients will be randomly divided into two groups using closed envelops.
Subjects who will receive bilateral superficial cervical plexus block is the interventional group whereas subjects who will receive local infiltration of lidocaine 2% is the control group.
Before, during, and after the procedure, all subjects are monitored (blood pressure, heart rate, respiratory rate, and electrocardiography). Monitoring data, including pain, will be recorded. Pain is measured by using visual analog scale or verbal numeric rating scale.
Arterial blood sample (approximately 3 cc) from each subject will be withdrawn twice and put into tubes containing anticoagulant for substance-P examination. Initial withdrawal is done before the anesthetics are given while the last one is done after the tracheostomy procedure.
Before the procedure, location for incision and block will be marked. Interventional group will be given 10 mL of Bupivacaine 0.5% on each side of the neck (as marked) by using 20 mL spuit with 25 G 1.5 inch needle whereas control group will be given 4 mL of Lidocaine 2% on incisional region (as marked) by using 5 mL spuit with 25 G 1.5 inch needle. 1 mg of Midazolam can be given intravenously before the block if there is no contraindication. Tracheostomy will be performed 15 minutes after the block is administered or local infiltration has worked. After tracheostomy, patients will be continually monitored in post-anesthesia care unit while their blood samples will be delivered to laboratory for ELISA test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Cipto Mangunkusumo Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Physical Status ASA 1-3
Exclusion Criteria:
- Pregnant
- Blood clotting disorder
- Allergic to anesthetics (Lidocaine, Bupivacaine) used in this study
- Local infection on procedure area
- Deformity on procedure area
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bilateral superficial cervical plexus block with Bupiv
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.
|
Patients undergoing tracheostomy procedure must be administered with analgesics, such Lidocaine 20% or Bupivacaine 0.5%
|
Active Comparator: Local infiltration of Lidocaine 2%
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.
|
Patients undergoing tracheostomy procedure must be administered with analgesics, such Lidocaine 20% or Bupivacaine 0.5%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of substance-P (Baseline)
Time Frame: 3 months
|
Substance-P level is measured as a pain indicator.
|
3 months
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Concentration of substance-P (After Tracheostomy)
Time Frame: 3 months
|
Substance-P level is measured as a pain indicator.
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Mehta C, Mehta Y. Percutaneous tracheostomy. Ann Card Anaesth. 2017 Jan;20(Supplement):S19-S25. doi: 10.4103/0971-9784.197793.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IndonesiaUAnes029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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