Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control
17 augustus 2018 bijgewerkt door: Anna Uskova, University of Pittsburgh
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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
45
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15237
- UPMC Passavant
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Pittsburgh, Pennsylvania, Verenigde Staten, 15232
- UPMC Presbyterian Shadyside
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- (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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Traditional approach paravertebral nerve block
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.
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Experimenteel: Ultrasound assisted paravertebral nerve block
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Opioid Consumption at 24 Hours Postoperatively
Tijdsspanne: 24 hours after patient-controlled analgesia (PCA) was initiated
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Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).
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24 hours after patient-controlled analgesia (PCA) was initiated
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Sensory Level
Tijdsspanne: 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.
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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.
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6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.
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Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing
Tijdsspanne: 24 hours post PCA initiation
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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.
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24 hours post PCA initiation
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Number of Local Anesthetic Boluses Requested by PCA
Tijdsspanne: 24 hours postoperatively
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The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded.
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24 hours postoperatively
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Total Local Anesthetic Infusions Over 24- Hour Period
Tijdsspanne: 24 hours postoperatively
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The total local anesthetic infusions over 24- hour period.
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24 hours postoperatively
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Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)
Tijdsspanne: Pre-operatively and at 24 hour post-operative
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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.
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Pre-operatively and at 24 hour post-operative
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Incentive Spirometry
Tijdsspanne: Preoperatively and Postoperatively
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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).
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Preoperatively and Postoperatively
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Respiratory Rate
Tijdsspanne: 24 hours postoperatively
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Respiratory rate (RR) per minute after surgery.
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24 hours postoperatively
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Forced Vital Capacity (FVC)
Tijdsspanne: Preoperatively and postoperatively
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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).
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Preoperatively and postoperatively
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Forced Expiratory Volume in 1 Sec (FEV1)
Tijdsspanne: Preoperatively and postoperatively
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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).
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Preoperatively and postoperatively
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Peak Expiratory Flow Rate(PEF)
Tijdsspanne: Preoperatively and postoperatively
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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).
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Preoperatively and postoperatively
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Total Number of Local Anesthetic Boluses in 24 Hours
Tijdsspanne: postoperatively, up to 24 hours
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Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.
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postoperatively, up to 24 hours
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Pusch 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.
- 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.
- Lonnqvist 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.
- Klein 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.
- Richardson 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.
- 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.
- Luyet C, Eichenberger U, Greif R, Vogt A, Szucs Farkas Z, Moriggl B. Ultrasound-guided paravertebral puncture and placement of catheters in human cadavers: an imaging study. Br J Anaesth. 2009 Apr;102(4):534-9. doi: 10.1093/bja/aep015. Epub 2009 Feb 24.
- Perttunen 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.
- Evans 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.
- Chan VWS, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-1517. doi: 10.1213/01.ANE.0000062519.61520.14.
- Marhofer P, Sitzwohl C, Greher M, Kapral S. Ultrasound guidance for infraclavicular brachial plexus anaesthesia in children. Anaesthesia. 2004 Jul;59(7):642-6. doi: 10.1111/j.1365-2044.2004.03669.x.
- Weltz 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.
- Vogt 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.
- Matthews 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.
- Ganapathy 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.
- Kirvela O, Antila H. Thoracic paravertebral block in chronic postoperative pain. Reg Anesth. 1992 Nov-Dec;17(6):348-50.
- Karmakar 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.
- Chelly JE. Peripheral Nerve Blocks: A Color Atlas. 2009. Third Edition. Lippincott Williams and Wilkins.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juli 2013
Primaire voltooiing (Werkelijk)
5 juni 2014
Studie voltooiing (Werkelijk)
5 juni 2014
Studieregistratiedata
Eerst ingediend
19 september 2013
Eerst ingediend dat voldeed aan de QC-criteria
23 september 2013
Eerst geplaatst (Schatting)
24 september 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 januari 2019
Laatste update ingediend die voldeed aan QC-criteria
17 augustus 2018
Laatst geverifieerd
1 augustus 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PRO09090367
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