Pain, PostoperativeNCT02814890
Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine
A study testing Video-assisted Pneumonectomy and Thoracic paravertebral block in people with Pain, Postoperative, run by Jianghui Xu at 1 site in China.
Trial summary
The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral block is performed at the end of video-assisted pneumonectomy. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Video-assisted Pneumonectomy and Thoracic paravertebral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-II grade
- Undergoing elective video-assisted pneumonectomy under general anesthesia.
- Participants aged from 30-70 years old.
Who cannot join
- Refusal for paravertebral block
- Inability to obtain informed consent
- Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2
- Pregnancy
- Infections at the site of injection for the paravertebral block
- Allergy to local anesthetics or alpha-2 adrenergic agonists
- Heart block or bradycardia (heart rate < 60 beat per minute)
- Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Thoracic Paravertebral Block Using Ropivacaine With/Without Dexmedetomidine in Video-assisted Pneumonectomy
The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral block is performed at the end of video-assisted pneumonectomy.
Read the detailed description
The investigators aim to recruit 60 patients undergoing video-assisted pneumonectomy. All patients ASA physical status I-II grade, aged within 20-70 years, are randomly allocated into two groups: 75mg/20ml ropivacaine only group (Group R, n=30) and 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine (Group RD, n=30). At the end of surgery, the investigators perform four points thoracic paravertebral block guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side where 5ml solution is injected to each point. The characteristics of patients are analyzed to confirm whether they are comparable in both groups. Pain was assessed according to a numerical rating scale (NRS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded in post anesthesia care unit(PACU), and1, 2,4, 8, 12, 24, 36 and 48 hours after surgery. The study endpoints are evaluated by an anesthesiologist who does not know the group allocation. The postoperative rescue analgesic administration, adverse outcomes and patient satisfaction are also recorded.
All data were processed in SPSS 18.0 (SPSS Inc., Chicago, IL USA). Normality was tested by the Kolmogorov-Smirnov analysis. Comparisons of continuous outcomes among groups were examined using Kruskal-Wallis test. Chi-square analysis or Fisher's exact test was used to assess categorical outcomes between groups. A P-value<0.05 was considered statistically significant.
- Conditions
- Pain, Postoperative
- Being tested
- Video-assisted Pneumonectomy, Thoracic paravertebral block
- Keywords
- Thoracic paravertebral block, Dexmedetomidine, Video-assisted Pneumonectomy, Ropivacaine, Pain, Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted PneumonectomyProcedure or surgery
Video-assisted Pneumonectomy under general anesthesia.
Thoracic paravertebral blockProcedure or surgery
Also called Thoracic paravertebral nerve block
The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine and dexmedetomidine | Experimental | Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy. Receives: Procedure: Video-assisted Pneumonectomy; Procedure: Thoracic paravertebral block |
| Ropivacaine only | Active comparator | Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy. Receives: Procedure: Video-assisted Pneumonectomy; Procedure: Thoracic paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain (Pain Scores) Intensity Measure
Pain Numerical Rating Scales （NRS) at rest（0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
Measured: assessed over 48 hours after surgery, self reported pain intensity at 2 days reported
Secondary outcomes (3)
Patient Satisfaction
using a 5-point Likert scale (5-point: completely satisfied, 4-point: quite satisfied, 3-point: slightly dissatisfied, 2-point: dissatisfied, 1-point: very dissatisfied)
Measured: Hour 48 after surgery
Number of Participants With Postoperative Rescue Analgesic Administration
a rescue analgesic morphine 5mg will be administered for any pain score ≥4 （0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
Measured: Hour 24, Hour 48 after surgery
Adverse Events
including nausea, vomiting, hypotension, bradycardia, and respiratory depression
Measured: Hour 48 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianghui Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianghui Xu, Huashan Hospital
- Investigators
- Jun Zhang, MD,PhD, Study chair, Department of Anesthesiology,Huashan Hospital,Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814890
- Sponsor's protocol ID
- 2011QD10
- Status last verified
- Aug 2019
- First submitted
- 21 Jun 2016
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Paravertebral Block Using Ropivacaine With/Without Dexmedetomidine in Video-assisted Pneumonectomy
- ClinicalTrials.gov ID
- NCT02814890
- Acronym / sponsor ID
- 2011QD10
- Conditions
- Pain, Postoperative
- Keywords
- Thoracic paravertebral block, Dexmedetomidine, Video-assisted Pneumonectomy, Ropivacaine, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Jianghui XuUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Posted 6 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral block is performed at the end of video-assisted pneumonectomy.
Detailed description
The investigators aim to recruit 60 patients undergoing video-assisted pneumonectomy. All patients ASA physical status I-II grade, aged within 20-70 years, are randomly allocated into two groups: 75mg/20ml ropivacaine only group (Group R, n=30) and 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine (Group RD, n=30). At the end of surgery, the investigators perform four points thoracic paravertebral block guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side where 5ml solution is injected to each point. The characteristics of patients are analyzed to confirm whether they are comparable in both groups. Pain was assessed according to a numerical rating scale (NRS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded in post anesthesia care unit(PACU), and1, 2,4, 8, 12, 24, 36 and 48 hours after surgery. The study endpoints are evaluated by an anesthesiologist who does not know the group allocation. The postoperative rescue analgesic administration, adverse outcomes and patient satisfaction are also recorded.
All data were processed in SPSS 18.0 (SPSS Inc., Chicago, IL USA). Normality was tested by the Kolmogorov-Smirnov analysis. Comparisons of continuous outcomes among groups were examined using Kruskal-Wallis test. Chi-square analysis or Fisher's exact test was used to assess categorical outcomes between groups. A P-value<0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine and dexmedetomidine | Experimental | Procedure: Video-assisted Pneumonectomy, Procedure: Thoracic paravertebral blockThoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy. |
| Ropivacaine only | Active comparator | Procedure: Video-assisted Pneumonectomy, Procedure: Thoracic paravertebral blockThoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I-II grade
- Undergoing elective video-assisted pneumonectomy under general anesthesia.
- Participants aged from 30-70 years old.
Key exclusion criteria (8 listed)
- Refusal for paravertebral block
- Inability to obtain informed consent
- Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2
- Pregnancy
- Infections at the site of injection for the paravertebral block
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 |
|---|---|---|
| Video-assisted PneumonectomyVideo-assisted Pneumonectomy under general anesthesia. | Procedure or surgery | Ropivacaine and dexmedetomidine, Ropivacaine only |
| Thoracic paravertebral blockAlso: Thoracic paravertebral nerve blockThe procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side. | Procedure or surgery | Ropivacaine and dexmedetomidine, Ropivacaine only |
Primary outcome
Postoperative Pain (Pain Scores) Intensity Measure
Time frame: assessed over 48 hours after surgery, self reported pain intensity at 2 days reported
Pain Numerical Rating Scales （NRS) at rest（0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
3 secondary outcomes
Patient Satisfaction
Time frame: Hour 48 after surgery
Number of Participants With Postoperative Rescue Analgesic Administration
Time frame: Hour 24, Hour 48 after surgery
Adverse Events
Time frame: Hour 48 after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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.
Jun Zhang, MD,PhD study chair
Department of Anesthesiology,Huashan Hospital,Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-assisted Pneumonectomy and Thoracic paravertebral block in people with Pain, Postoperative, run by Jianghui Xu 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 3 inclusion and 8 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 6 Aug 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 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. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Pain (Pain Scores) Intensity Measure (time frame: assessed over 48 hours after surgery, self reported pain intensity at 2 days reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2020.