Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control

Acute Pain Management Clinical Trial

Official title:

Comparison Of Ultrasound-Assisted Paravertebral Block And Traditional Paravertebral Block For Pain Control After Thoracic Surgery, A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949480
• Other study ID #: PRO09090367
• Status: Completed
• Phase: N/A
• Start date: July 1, 2013
• Est. completion date: June 5, 2014

Study information

• Verified date: August 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 5, 2014
• Est. primary completion date: June 5, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Management
• Paravertebral Peripheral Nerve Block

Intervention

Procedure:
• Thoracotomy

• Video-Assisted Thoracoscopic Surgery (VATS)

Locations

Country	Name	City	State
United States	UPMC Passavant	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian Shadyside	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (18)

Chan VW, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-7. — View Citation

Chelly JE. Peripheral Nerve Blocks: A Color Atlas. 2009. Third Edition. Lippincott Williams and Wilkins.

Evans PJ, Lloyd JW, Wood GJ. Accidental intrathecal injection of bupivacaine and dextran. Anaesthesia. 1981 Jul;36(7):685-7. — View Citation

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. — View Citation

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. — View Citation

Kirvelä O, Antila H. Thoracic paravertebral block in chronic postoperative pain. Reg Anesth. 1992 Nov-Dec;17(6):348-50. — View Citation

Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. — View Citation

Lönnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. — View Citation

Luyet C, Eichenberger U, Greif R, Vogt A, Szücs 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. — View Citation

Marhofer P, Sitzwohl C, Greher M, Kapral S. Ultrasound guidance for infraclavicular brachial plexus anaesthesia in children. Anaesthesia. 2004 Jul;59(7):642-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Richardson J, Vowden P, Sabanathan S. Bilateral paravertebral analgesia for major abdominal vascular surgery: a preliminary report. Anaesthesia. 1995 Nov;50(11):995-8. — View Citation

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. — View Citation

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. Epub 2005 Sep 30. — View Citation

Weltz CR, Greengrass RA, Lyerly HK. Ambulatory surgical management of breast carcinoma using paravertebral block. Ann Surg. 1995 Jul;222(1):19-26. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 hours after patient-controlled analgesia (PCA) was initiated
Secondary	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.	6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.
Secondary	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.	24 hours post PCA initiation
Secondary	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.	24 hours postoperatively
Secondary	Total Local Anesthetic Infusions Over 24- Hour Period	The total local anesthetic infusions over 24- hour period.	24 hours postoperatively
Secondary	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.	Pre-operatively and at 24 hour post-operative
Secondary	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).	Preoperatively and Postoperatively
Secondary	Respiratory Rate	Respiratory rate (RR) per minute after surgery.	24 hours postoperatively
Secondary	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).	Preoperatively and postoperatively
Secondary	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).	Preoperatively and postoperatively
Secondary	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).	Preoperatively and postoperatively
Secondary	Total Number of Local Anesthetic Boluses in 24 Hours	Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.	postoperatively, up to 24 hours

External Links

•   University of Pittsburgh Department of Anesthesiology
•   University of Pittsburgh Institutional Review Board