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SurgeryNCT02871193

Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy

A study testing Ropivacaine, Dexamethasone and saline in people with Surgery, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The procedures of thoracotomy are among the most painful operations. In addition to post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative discomfort. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Surgery
What is being tested?
Ropivacaine, Dexamethasone and saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteChina
Study dates
1 Jun 2016to 20 Jan 2017
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 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patient American Society of Anesthesiologists（ASA） I~III undergoing elective thoracotomy
  • written informed consent from the patient or the relatives of the participating patient

Who cannot join

  • mental illness
  • thoracic paravertebral blocks contraindicated
  • local anesthetic allergy
  • people who have heart disease
  • people who have severe liver or renal disease
  • people who have severe endocrine disease
  • people who can't communicate effectively because of hearing or visual disorders

Trial locations and contacts

1 site in 1 country.

China1 site

  • The first affiliated hospital of Anhui Medical University

    Hefei, Anhui, 230000

Other trials in China

About this study

Official title: Study of Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy

The procedures of thoracotomy are among the most painful operations. In addition to post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative discomfort. Therefore, post-thoracotomy pain control can improve the satisfaction of patient and prevent postoperative complications such as pneumonia, atelectasis, or respiratory failure. Thoracic epidural analgesia (TEA) used to be widely considered as a standard technique for providing analgesia after a thoracotomy. However, TEA carries side-effects such as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory depression, or bradycardia, etc. Recently, thoracic paravertebral block (TPVB) is an alternative technique for TEA that may offer a comparable analgesic effect and a better side -effect profile for post-thoracotomy analgesia. When local anesthetic agents are used as single injection, they can provide analgesia for limited period. Various adjuvants have been tried in the past in order to enhance the duration and quality of postoperative analgesia. Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of local anesthetic block. The mechanism of its action is blocking the nociceptive impulse transmission along the myelinated C fibers. Patient-controlled analgesia (PCA) devices have been shown to provide superior analgesia and greater patient satisfaction compared with intermittent administration. System of wire-less PCA provides remote monitoring, information management and PCA devices with high precision. The purpose of this research is to determine whether dexamethasone might prolong the duration of analgesia and improve the short-time outcomes when administered for TPVB along with local anesthetic agents in elective thoracotomy.

Conditions
Surgery
Being tested
Ropivacaine, Dexamethasone, saline
Keywords
paravertebral block, patient controlled analgesia, ropivacaine, dexamethasone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivacaineDrug

    Also called ropivacaine hydrochloride

    ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml

  • DexamethasoneDrug

    Also called dxm, dex

    ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg

  • salineOther

    Also called normal saline

    ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml

Study groups in NCT02871193
Study groupRoleWhat they receive
Group C（Control）Sham comparatorGroup C received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml combined with general anesthesia and intravenous patient controlled analgesia pump.
Receives: Other: saline
Group R(Ropivacaine)ExperimentalGroup R received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20 ml combined with general anesthesia and intravenous patient controlled analgesia pump.
Receives: Drug: Ropivacaine
Group D(Dexamethasone)ExperimentalGroup D received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg combined with general anesthesia and intravenous patient controlled analgesia pump.
Receives: Drug: Ropivacaine; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy

    to show the grading of pain in different groups after surgery

    Measured: 6 hours,12hours,24hours and 72hours after operation

  2. the reality pressing number of patient controlled analgesia(PCA) of patients with different treatment-related events in the following 3 days after surgery

    to show the consumption of analgesics after surgery

    Measured: 6hours,12hours,24hours and 72hours after operation

Secondary outcomes (6)

  1. hemodynamic index

    To show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy.

    Measured: 24 hours after anesthesia

  2. The time of recovery

    to show the quality of recovery

    Measured: 24 hours after surgery

  3. The time of extubation

    to show the quality of recovery

    Measured: 24 hours after surgery

  4. the incidence of side effects

    To compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation.

    Measured: 3days after operation

  5. The complication after surgery

    To compare the incidence rates of complications, such as pneumonia, atelectasis, respiratory failure, heart failure, etc

    Measured: 30 days after surgery

  6. The first day of leaving bed after surgery

    Measured: 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2016 (estimated)
  2. Study start1 Jun 2016
  3. Primary completion8 Oct 2016
  4. Study completion20 Jan 2017

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871193
Sponsor's protocol ID
Kuai2016-06-08
Status last verified
Feb 2017
First submitted
17 Jul 2016
Last updated
9 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Carmona P, Llagunes J, Canovas S, de Andres J, Marques I. The role of continuous thoracic paravertebral block for fast-track anesthesia after cardiac surgery via thoracotomy. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):205-6. doi: 10.1053/j.jvca.2010.04.005. No abstract available.

    PubMed 20599397

  • Tomar GS, Ganguly S, Cherian G. Effect of Perineural Dexamethasone With Bupivacaine in Single Space Paravertebral Block for Postoperative Analgesia in Elective Nephrectomy Cases: A Double-Blind Placebo-Controlled Trial. Am J Ther. 2017 Nov/Dec;24(6):e713-e717. doi: 10.1097/MJT.0000000000000405.

    PubMed 26938764

  • Ilfeld BM, Madison SJ, Suresh PJ, Sandhu NS, Kormylo NJ, Malhotra N, Loland VJ, Wallace MS, Proudfoot JA, Morgan AC, Wen CH, Wallace AM. Treatment of postmastectomy pain with ambulatory continuous paravertebral nerve blocks: a randomized, triple-masked, placebo-controlled study. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):89-96. doi: 10.1097/AAP.0000000000000035.

    PubMed 24448512

  • Ke JD, Hou HJ, Wang M, Zhang YJ. The comparison of anesthesia effect of lung surgery through video-assisted thoracic surgery: A meta-analysis. J Cancer Res Ther. 2015 Nov;11 Suppl:C265-70. doi: 10.4103/0973-1482.170534.

    PubMed 26612450

  • Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.

    PubMed 25123271

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine, Dexamethasone and saline in people with Surgery, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.

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 2 inclusion and 7 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 9 Feb 2017. 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 China. 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. Some participants in this study may receive a placebo. 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?

the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy (time frame: 6 hours,12hours,24hours and 72hours after operation). 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 NCT02871193, which also lists 5 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 9 Feb 2017.

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