TracheostomyNCT04006639
Efficacy of Bilateral Superficial Cervical Plexus Block vs. Local Infiltration of Lidocaine 2% in Tracheostomy Procedure
A study testing Analgesic Technique in people with Tracheostomy, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tracheostomy
- What is being tested?
- Analgesic Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical Status ASA 1-3
Who cannot join
- Pregnant
- Blood clotting disorder
- Allergic to anesthetics (Lidocaine, Bupivacaine) used in this study
- Local infection on procedure area
- Deformity on procedure area
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Comparison of Efficacy Between Bilateral Superficial Cervical Plexus Block and Local Infiltration of Lidocaine 2% in Patients Undergoing Tracheostomy
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.
Read the 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.
- Conditions
- Tracheostomy
- Being tested
- Analgesic Technique
- Keywords
- local infiltration, bilateral superficial cervical plexus block, lidocaine, bupivacaine, substance-p
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesic TechniqueProcedure or surgery
Patients undergoing tracheostomy procedure must be administered with analgesics, such Lidocaine 20% or Bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Analgesic Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of substance-P (Baseline)
Substance-P level is measured as a pain indicator.
Measured: 3 months
Concentration of substance-P (After Tracheostomy)
Substance-P level is measured as a pain indicator.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Aug 2019
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pryambodho Pryambodho, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006639
- Sponsor's protocol ID
- IndonesiaUAnes029
- Status last verified
- Dec 2019
- First submitted
- 27 May 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17576970Brandow 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.
PubMed 27539682Douglas 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.
PubMed 27539537De 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.
PubMed 17588767Fernandez-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.
PubMed 26348694Griffiths 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.
PubMed 15901643Mehta C, Mehta Y. Percutaneous tracheostomy. Ann Card Anaesth. 2017 Jan;20(Supplement):S19-S25. doi: 10.4103/0971-9784.197793.
PubMed 28074819
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy Between Bilateral Superficial Cervical Plexus Block and Local Infiltration of Lidocaine 2% in Patients Undergoing Tracheostomy
- ClinicalTrials.gov ID
- NCT04006639
- Acronym / sponsor ID
- IndonesiaUAnes029
- Conditions
- Tracheostomy
- Keywords
- local infiltration, bilateral superficial cervical plexus block, lidocaine, bupivacaine, substance-p
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral superficial cervical plexus block with Bupiv | Active comparator | Procedure: Analgesic TechniquePatients, 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. |
| Local infiltration of Lidocaine 2% | Active comparator | Procedure: Analgesic TechniquePatients, 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physical Status ASA 1-3
Key exclusion criteria (5 listed)
- Pregnant
- Blood clotting disorder
- Allergic to anesthetics (Lidocaine, Bupivacaine) used in this study
- Local infection on procedure area
- Deformity on procedure area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analgesic TechniquePatients undergoing tracheostomy procedure must be administered with analgesics, such Lidocaine 20% or Bupivacaine 0.5% | Procedure or surgery | Bilateral superficial cervical plexus block with Bupiv, Local infiltration of Lidocaine 2% |
Primary outcome
Concentration of substance-P (Baseline)
Time frame: 3 months
Substance-P level is measured as a pain indicator.
Concentration of substance-P (After Tracheostomy)
Time frame: 3 months
Substance-P level is measured as a pain indicator.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Results publication: PubMed 17576970Pandit 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.
- Results publication: PubMed 27539682Brandow 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.
- Results publication: PubMed 27539537Douglas 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.
- Results publication: PubMed 17588767De 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.
- Results publication: PubMed 26348694Fernandez-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.
- Results publication: PubMed 15901643Griffiths 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.
- Results publication: PubMed 28074819Mehta C, Mehta Y. Percutaneous tracheostomy. Ann Card Anaesth. 2017 Jan;20(Supplement):S19-S25. doi: 10.4103/0971-9784.197793.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesic Technique in people with Tracheostomy, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of substance-P (Baseline) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006639, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.