Paravertebral Peripheral Nerve BlockNCT01949480
Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control
A study testing Thoracotomy and Video-Assisted Thoracoscopic Surgery (VATS) in people with Paravertebral Peripheral Nerve Block and Acute Pain Management, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The overall purpose of this research study is to compare the effectiveness of ultrasound assisted paravertebral block placement versus traditional "blind" technique for postoperative analgesia following thoracotomy or visually assisted thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Paravertebral Peripheral Nerve Block, Acute Pain Management
- What is being tested?
- Thoracotomy and Video-Assisted Thoracoscopic Surgery (VATS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2013to 5 Jun 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. American Society of Anesthesiologists (ASA) I-III subjects
- 2. Ages 18-75 years
- 3. BMI < 40
- 4. Scheduled for elective thoracic surgery at University of Pittsburgh Medical Center (UPMC) Passavant and Shadyside Hospitals in Pittsburgh, Pennsylvania
- 5. Patients willing and able to provide informed consent
Who cannot join
- 1) Age younger than 18 years or older than 75 years
- (2) Any contraindication to the placement of unilateral thoracic paravertebral catheter, including local infection, hypocoagulable state.
- (3) American Society of Anesthesiologists physical status IV or greater
- (4) chronic painful conditions
- (5) preoperative opioid use
- (6) coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
Show all 19Show fewer
- (7) allergy to lidocaine, ropivacaine or bupivacaine
- (8) personal or family history of malignant hyperthermia
- (9) serum creatinine greater than 1.4 g/dl
- (10) pregnancy or lactating.The pregnancy status will be determined by history and prior pregnancy testing when appropriate
- (11) having an altered mental status (not oriented to place, person, or time) or emergency surgery
- (12) comorbid conditions such as sepsis, unstable angina, congestive heart failure, moderate to severe valvular heart disease, severe chronic obstructive pulmonary disease (COPD)
- (13) patient's inability to provide adequate informed consent
- (14) patient refusal to nerve blocks and/or participation in the study
- (15) respiratory support via ventilator post
- (16) non English speaking
- (17) allergy to contrast of iodine
- (18) emergency surgery or any other non-elective procedure
- (19) unstable vertebral and transverse process fractures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15232
UPMC Passavant
Pittsburgh, Pennsylvania, 15237
About this study
Official title: Comparison Of Ultrasound-Assisted Paravertebral Block And Traditional Paravertebral Block For Pain Control After Thoracic Surgery, A Prospective Randomized Trial
The overall purpose of this research study is to compare the effectiveness of ultrasound assisted paravertebral block placement versus traditional "blind" technique for postoperative analgesia following thoracotomy or visually assisted thoracoscopic surgery.
Read the detailed description
The purpose of this project is to determine if there is a difference between paravertebral block performed with ultrasound assistance and paravertebral block performed with traditional technique in terms of twenty - four hour hydromorphone (dilaudid) consumption and visual analogue pain scores at rest or with deep breathing at twenty - four hours. This study will determine if ultrasound technique used for placement of paravertebral catheter facilitates safety of paravertebral catheterization and improves therapeutic effect of paravertebral blockade for pain control after thoracotomy. The investigators will also examine if ultrasound assisted paravertebral blockade improves pulmonary status in post-thoracotomy patient.
- Being tested
- Thoracotomy, Video-Assisted Thoracoscopic Surgery (VATS)
- Keywords
- Peripheral nerve block, Ultrasound guidance, Postoperative pain management post status thoracotomy, Postoperative pain management post status VATS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracotomyProcedure or surgery
Video-Assisted Thoracoscopic Surgery (VATS)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Traditional approach paravertebral nerve block | Active comparator | After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing. Receives: Procedure: Thoracotomy; Procedure: Video-Assisted Thoracoscopic Surgery (VATS) |
| Ultrasound assisted paravertebral nerve block | Experimental | The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing. Receives: Procedure: Thoracotomy; Procedure: Video-Assisted Thoracoscopic Surgery (VATS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption at 24 Hours Postoperatively
Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).
Measured: 24 hours after patient-controlled analgesia (PCA) was initiated
Secondary outcomes (11)
Sensory Level
Sensory level as assessed by temperature and pin prick test assessed every 5 min for 30 min after nerve block as defined as the patient returning to their bed. Data below are in number of patients who didn't have any change during the ice and pin prik test.
Measured: 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.
Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing
The pain level assessed using an 11-point numerical rating scale (NRS) with 0 indicating no pain and 10 indicating the worst pain possible with deep breathing and rest at 24 hours post PCA initiation.
Measured: 24 hours post PCA initiation
Number of Local Anesthetic Boluses Requested by PCA
The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded.
Measured: 24 hours postoperatively
Total Local Anesthetic Infusions Over 24- Hour Period
The total local anesthetic infusions over 24- hour period.
Measured: 24 hours postoperatively
Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)
Inspired oxygen concentration and SpO2 preoperatively and at 24 - hour interval. Value reported is an average of the preoperative and the 24-hour postoperative SpO2 measurements.
Measured: Pre-operatively and at 24 hour post-operative
Incentive Spirometry
Inspiratory Volume as measured by incentive spirometer preoperatively and at 24 hours post PCA initiation. The data is reported as a percentage in change from per-surgery measurements (post-surgery/pre-surgery).
Measured: Preoperatively and Postoperatively
Respiratory Rate
Respiratory rate (RR) per minute after surgery.
Measured: 24 hours postoperatively
Forced Vital Capacity (FVC)
Forced vital capacity (FVC) measured preoperatively and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).
Measured: Preoperatively and postoperatively
Forced Expiratory Volume in 1 Sec (FEV1)
Forced expiratory volume in 1 sec (FEV1) preoperatively and at 24 - hour interval. Then the values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).
Measured: Preoperatively and postoperatively
Peak Expiratory Flow Rate(PEF)
Peak expiratory flow rate preoperatively (PEF) and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).
Measured: Preoperatively and postoperatively
Total Number of Local Anesthetic Boluses in 24 Hours
Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.
Measured: postoperatively, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study start1 Jul 2013
- Primary completion5 Jun 2014
- Study completion5 Jun 2014
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.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Paravertebral Peripheral Nerve BlockStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Uskova, University of Pittsburgh
- Investigators
- Anna Uskova, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949480
- Sponsor's protocol ID
- PRO09090367
- Status last verified
- Aug 2018
- First submitted
- 19 Sep 2013
- Last updated
- 22 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Richardson J, Sabanathan S, Jones J, Shah RD, Cheema S, Mearns AJ. A prospective, randomized comparison of preoperative and continuous balanced epidural or paravertebral bupivacaine on post-thoracotomy pain, pulmonary function and stress responses. Br J Anaesth. 1999 Sep;83(3):387-92. doi: 10.1093/bja/83.3.387.
PubMed 10655907Perttunen K, Nilsson E, Heinonen J, Hirvisalo EL, Salo JA, Kalso E. Extradural, paravertebral and intercostal nerve blocks for post-thoracotomy pain. Br J Anaesth. 1995 Nov;75(5):541-7. doi: 10.1093/bja/75.5.541.
PubMed 7577277Matthews PJ, Govenden V. Comparison of continuous paravertebral and extradural infusions of bupivacaine for pain relief after thoracotomy. Br J Anaesth. 1989 Feb;62(2):204-5. doi: 10.1093/bja/62.2.204.
PubMed 2923769Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x.
PubMed 7573876Vogt A, Stieger DS, Theurillat C, Curatolo M. Single-injection thoracic paravertebral block for postoperative pain treatment after thoracoscopic surgery. Br J Anaesth. 2005 Dec;95(6):816-21. doi: 10.1093/bja/aei250. Epub 2005 Sep 30.
PubMed 16199417Ganapathy S, Murkin JM, Boyd DW, Dobkowski W, Morgan J. Continuous percutaneous paravertebral block for minimally invasive cardiac surgery. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):594-6. doi: 10.1016/s1053-0770(99)90015-0. No abstract available.
PubMed 10527232Weltz CR, Greengrass RA, Lyerly HK. Ambulatory surgical management of breast carcinoma using paravertebral block. Ann Surg. 1995 Jul;222(1):19-26. doi: 10.1097/00000658-199507000-00004.
PubMed 7618963Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.
PubMed 10825328Pusch F, Freitag H, Weinstabl C, Obwegeser R, Huber E, Wildling E. Single-injection paravertebral block compared to general anaesthesia in breast surgery. Acta Anaesthesiol Scand. 1999 Aug;43(7):770-4. doi: 10.1034/j.1399-6576.1999.430714.x.
PubMed 10456819Richardson J, Vowden P, Sabanathan S. Bilateral paravertebral analgesia for major abdominal vascular surgery: a preliminary report. Anaesthesia. 1995 Nov;50(11):995-8. doi: 10.1111/j.1365-2044.1995.tb05939.x.
PubMed 8678263Kirvela O, Antila H. Thoracic paravertebral block in chronic postoperative pain. Reg Anesth. 1992 Nov-Dec;17(6):348-50.
PubMed 1286056Karmakar MK, Chui PT, Joynt GM, Ho AM. Thoracic paravertebral block for management of pain associated with multiple fractured ribs in patients with concomitant lumbar spinal trauma. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):169-73. doi: 10.1053/rapm.2001.21086.
PubMed 11251143Chelly JE. Peripheral Nerve Blocks: A Color Atlas. 2009. Third Edition. Lippincott Williams and Wilkins.
Terheggen MA, Wille F, Borel Rinkes IH, Ionescu TI, Knape JT. Paravertebral blockade for minor breast surgery. Anesth Analg. 2002 Feb;94(2):355-9, table of contents. doi: 10.1097/00000539-200202000-00023.
PubMed 11812698Evans PJ, Lloyd JW, Wood GJ. Accidental intrathecal injection of bupivacaine and dextran. Anaesthesia. 1981 Jul;36(7):685-7. doi: 10.1111/j.1365-2044.1981.tb08781.x.
PubMed 6168207
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Ultrasound-Assisted Paravertebral Block And Traditional Paravertebral Block For Pain Control After Thoracic Surgery, A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01949480
- Acronym / sponsor ID
- PRO09090367
- Keywords
- Peripheral nerve block, Ultrasound guidance, Postoperative pain management post status thoracotomy, Postoperative pain management post status VATS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 5 Jun 2014 (actual)
- Study completion
- 5 Jun 2014 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Posted 22 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this research study is to compare the effectiveness of ultrasound assisted paravertebral block placement versus traditional "blind" technique for postoperative analgesia following thoracotomy or visually assisted thoracoscopic surgery.
Detailed description
The purpose of this project is to determine if there is a difference between paravertebral block performed with ultrasound assistance and paravertebral block performed with traditional technique in terms of twenty - four hour hydromorphone (dilaudid) consumption and visual analogue pain scores at rest or with deep breathing at twenty - four hours. This study will determine if ultrasound technique used for placement of paravertebral catheter facilitates safety of paravertebral catheterization and improves therapeutic effect of paravertebral blockade for pain control after thoracotomy. The investigators will also examine if ultrasound assisted paravertebral blockade improves pulmonary status in post-thoracotomy patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional approach paravertebral nerve block | Active comparator | Procedure: Thoracotomy, Procedure: Video-Assisted Thoracoscopic Surgery (VATS)After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing. |
| Ultrasound assisted paravertebral nerve block | Experimental | Procedure: Thoracotomy, Procedure: Video-Assisted Thoracoscopic Surgery (VATS)The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. American Society of Anesthesiologists (ASA) I-III subjects
- 2. Ages 18-75 years
- 3. BMI < 40
- 4. Scheduled for elective thoracic surgery at University of Pittsburgh Medical Center (UPMC) Passavant and Shadyside Hospitals in Pittsburgh, Pennsylvania
- 5. Patients willing and able to provide informed consent
Key exclusion criteria (19 listed)
- 1) Age younger than 18 years or older than 75 years
- (2) Any contraindication to the placement of unilateral thoracic paravertebral catheter, including local infection, hypocoagulable state.
- (3) American Society of Anesthesiologists physical status IV or greater
- (4) chronic painful conditions
- (5) preoperative opioid use
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 |
|---|---|---|
| Thoracotomy | Procedure or surgery | Traditional approach paravertebral nerve block, Ultrasound assisted paravertebral nerve block |
| Video-Assisted Thoracoscopic Surgery (VATS) | Procedure or surgery | Traditional approach paravertebral nerve block, Ultrasound assisted paravertebral nerve block |
Primary outcome
Opioid Consumption at 24 Hours Postoperatively
Time frame: 24 hours after patient-controlled analgesia (PCA) was initiated
Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).
11 secondary outcomes
Sensory Level
Time frame: 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.
Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing
Time frame: 24 hours post PCA initiation
Number of Local Anesthetic Boluses Requested by PCA
Time frame: 24 hours postoperatively
Total Local Anesthetic Infusions Over 24- Hour Period
Time frame: 24 hours postoperatively
Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)
Time frame: Pre-operatively and at 24 hour post-operative
Incentive Spirometry
Time frame: Preoperatively and Postoperatively
Respiratory Rate
Time frame: 24 hours postoperatively
Forced Vital Capacity (FVC)
Time frame: Preoperatively and postoperatively
Forced Expiratory Volume in 1 Sec (FEV1)
Time frame: Preoperatively and postoperatively
Peak Expiratory Flow Rate(PEF)
Time frame: Preoperatively and postoperatively
Total Number of Local Anesthetic Boluses in 24 Hours
Time frame: postoperatively, up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10655907Richardson J, Sabanathan S, Jones J, Shah RD, Cheema S, Mearns AJ. A prospective, randomized comparison of preoperative and continuous balanced epidural or paravertebral bupivacaine on post-thoracotomy pain, pulmonary function and stress responses. Br J Anaesth. 1999 Sep;83(3):387-92. doi: 10.1093/bja/83.3.387.
- Background: PubMed 7577277Perttunen K, Nilsson E, Heinonen J, Hirvisalo EL, Salo JA, Kalso E. Extradural, paravertebral and intercostal nerve blocks for post-thoracotomy pain. Br J Anaesth. 1995 Nov;75(5):541-7. doi: 10.1093/bja/75.5.541.
- Background: PubMed 2923769Matthews PJ, Govenden V. Comparison of continuous paravertebral and extradural infusions of bupivacaine for pain relief after thoracotomy. Br J Anaesth. 1989 Feb;62(2):204-5. doi: 10.1093/bja/62.2.204.
- Background: PubMed 7573876Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x.
- Background: PubMed 16199417Vogt A, Stieger DS, Theurillat C, Curatolo M. Single-injection thoracic paravertebral block for postoperative pain treatment after thoracoscopic surgery. Br J Anaesth. 2005 Dec;95(6):816-21. doi: 10.1093/bja/aei250. Epub 2005 Sep 30.
- Background: PubMed 10527232Ganapathy S, Murkin JM, Boyd DW, Dobkowski W, Morgan J. Continuous percutaneous paravertebral block for minimally invasive cardiac surgery. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):594-6. doi: 10.1016/s1053-0770(99)90015-0. No abstract available.
- Background: PubMed 7618963Weltz CR, Greengrass RA, Lyerly HK. Ambulatory surgical management of breast carcinoma using paravertebral block. Ann Surg. 1995 Jul;222(1):19-26. doi: 10.1097/00000658-199507000-00004.
- Background: PubMed 10825328Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.
- Background: PubMed 10456819Pusch F, Freitag H, Weinstabl C, Obwegeser R, Huber E, Wildling E. Single-injection paravertebral block compared to general anaesthesia in breast surgery. Acta Anaesthesiol Scand. 1999 Aug;43(7):770-4. doi: 10.1034/j.1399-6576.1999.430714.x.
- Background: PubMed 8678263Richardson J, Vowden P, Sabanathan S. Bilateral paravertebral analgesia for major abdominal vascular surgery: a preliminary report. Anaesthesia. 1995 Nov;50(11):995-8. doi: 10.1111/j.1365-2044.1995.tb05939.x.
- Background: PubMed 1286056Kirvela O, Antila H. Thoracic paravertebral block in chronic postoperative pain. Reg Anesth. 1992 Nov-Dec;17(6):348-50.
- Background: PubMed 11251143Karmakar MK, Chui PT, Joynt GM, Ho AM. Thoracic paravertebral block for management of pain associated with multiple fractured ribs in patients with concomitant lumbar spinal trauma. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):169-73. doi: 10.1053/rapm.2001.21086.
- University of Pittsburgh Institutional Review BoardLink provided by the sponsor.
- University of Pittsburgh Department of AnesthesiologyLink provided by the sponsor.
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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.
Anna Uskova, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracotomy and Video-Assisted Thoracoscopic Surgery (VATS) in people with Paravertebral Peripheral Nerve Block and Acute Pain Management, run by University of Pittsburgh at 2 sites in United States.
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 5 inclusion and 19 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 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 22 Jan 2019). 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?
Opioid Consumption at 24 Hours Postoperatively (time frame: 24 hours after patient-controlled analgesia (PCA) was initiated). 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 NCT01949480, which also lists 18 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 22 Jan 2019.