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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracotomy | Procedure |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Uskova, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Shadyside | Pittsburgh | Pennsylvania | 15232 | United States | ||
| UPMC Passavant |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10655907 | Background | 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. | |
| 7577277 | Background |
| Label | URL |
|---|---|
| University of Pittsburgh Institutional Review Board | View source |
Not provided
3 of the 45 consented patients were excluded because they did not meet inclusion criteria
From July 1, 2013- May 29 2014, 45 patients scheduled for thoracic surgery were approached in the preoperative setting and consented for the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Thoracotomy Video-Assisted Thoracoscopic Surgery (VATS) |
| FG001 | 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. Thoracotomy Video-Assisted Thoracoscopic Surgery (VATS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Thoracotomy Video-Assisted Thoracoscopic Surgery (VATS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | mg | 24 hours after patient-controlled analgesia (PCA) was initiated |
|
Adverse events collected for 24 hours post-operatively
If the adverse event (AE) resulted in prolonged hospitalization, serious illness or death, it would be considered a Serious Adverse Event (SAE).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Thoracotomy Video-Assisted Thoracoscopic Surgery (VATS) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter leaking | Surgical and medical procedures | Systematic Assessment | Catheter leaking/repositioned in pleural space |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna Uskova, Principal Investigator | University of Pittsburgh | 412) 623-2167 | UskoAA@anes.upmc.edu |
Not provided
| ID | Term |
|---|---|
| D013908 | Thoracotomy |
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D019616 | Thoracic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
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| Video-Assisted Thoracoscopic Surgery (VATS) |
| Procedure |
|
| 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 |
| 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 |
| Total Local Anesthetic Infusions Over 24- Hour Period | The total local anesthetic infusions over 24- hour period. | 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. | 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). | Preoperatively and Postoperatively |
| Respiratory Rate | Respiratory rate (RR) per minute after surgery. | 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). | 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). | 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). | 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. | postoperatively, up to 24 hours |
| Pittsburgh |
| Pennsylvania |
| 15237 |
| United States |
| 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. |
| 2923769 | Background | 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. |
| 7573876 | Background | 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. |
| 16199417 | Background | 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. |
| 10527232 | Background | 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. |
| 7618963 | Background | 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. |
| 10825328 | Background | 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. |
| 10456819 | Background | 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. |
| 8678263 | Background | 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. |
| 1286056 | Background | Kirvela O, Antila H. Thoracic paravertebral block in chronic postoperative pain. Reg Anesth. 1992 Nov-Dec;17(6):348-50. |
| 11251143 | Background | 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. |
| Background | Chelly JE. Peripheral Nerve Blocks: A Color Atlas. 2009. Third Edition. Lippincott Williams and Wilkins. |
| 11812698 | Background | 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. |
| 6168207 | Background | 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. |
| 14570677 | Background | 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. |
| 15200537 | Background | 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. |
| 19244265 | Background | 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. |
| University of Pittsburgh Department of Anesthesiology | View source |
| BG001 | 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. Thoracotomy Video-Assisted Thoracoscopic Surgery (VATS) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. Thoracotomy Video-Assisted Thoracoscopic Surgery (VATS) |
|
|
|
| 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. | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Count of Participants | Participants | 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. | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | units on a scale | 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. | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | Number of boluses requested | 24 hours postoperatively |
|
|
|
|
| Secondary | Total Local Anesthetic Infusions Over 24- Hour Period | The total local anesthetic infusions over 24- hour period. | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | mL | 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. | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | Percentage of SpO2 | 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). | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | percentage in change from per-surgery | Preoperatively and Postoperatively |
|
|
|
|
| Secondary | Respiratory Rate | Respiratory rate (RR) per minute after surgery. | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | breaths per one minute | 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). | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | percentage in change from per-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). | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | percentage in change from per-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). | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | percentage in change from per-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. | There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning. | Posted | Mean | 95% Confidence Interval | number of boluses | postoperatively, up to 24 hours |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | 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. Thoracotomy Video-Assisted Thoracoscopic Surgery (VATS) | 0 | 22 | 0 | 22 | 3 | 22 |
|
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| D003949 |
| Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
This p-value is calculated for the NRS during deep inspiration at 24 hrs.
| t-test, 2 sided |
| 0.39 |
| Non-Inferiority |
To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated. |