Acute Pain Management, Paravertebral Peripheral Nerve Block
Conditions
Keywords
Peripheral nerve block, Ultrasound guidance, Postoperative pain management post status thoracotomy, Postoperative pain management post status VATS
Brief 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.
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.
Interventions
PROCEDUREThoracotomy
PROCEDUREVideo-Assisted Thoracoscopic Surgery (VATS)
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption at 24 Hours Postoperatively | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing | 24 hours post PCA initiation | 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. |
| Number of Local Anesthetic Boluses Requested by PCA | 24 hours postoperatively | The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded. |
| Total Local Anesthetic Infusions Over 24- Hour Period | 24 hours postoperatively | The total local anesthetic infusions over 24- hour period. |
| Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2) | Pre-operatively and at 24 hour post-operative | 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. |
| Incentive Spirometry | Preoperatively and Postoperatively | 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). |
| Sensory Level | 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block. | 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. |
| Forced Vital Capacity (FVC) | Preoperatively and postoperatively | 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). |
| Forced Expiratory Volume in 1 Sec (FEV1) | Preoperatively and postoperatively | 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). |
| Peak Expiratory Flow Rate(PEF) | Preoperatively and postoperatively | 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). |
| Total Number of Local Anesthetic Boluses in 24 Hours | postoperatively, up to 24 hours | Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively. |
| Respiratory Rate | 24 hours postoperatively | Respiratory rate (RR) per minute after surgery. |
Countries
United States
Participant flow
Recruitment details
From July 1, 2013- May 29 2014, 45 patients scheduled for thoracic surgery were approached in the preoperative setting and consented for the study.
Pre-assignment details
3 of the 45 consented patients were excluded because they did not meet inclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| 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) | 20 |
| 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) | 22 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 5 | 8 |
Baseline characteristics
| Characteristic | Ultrasound Assisted Paravertebral Nerve Block | Traditional Approach Paravertebral Nerve Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 12 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Continuous | 64 years | 68 years | 66 years |
| Region of Enrollment United States | 22 participants | 20 participants | 42 participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 22 |
| other Total, other adverse events | 2 / 20 | 3 / 22 |
| serious Total, serious adverse events | 0 / 20 | 0 / 22 |
Outcome results
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).
Time frame: 24 hours after patient-controlled analgesia (PCA) was initiated
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Opioid Consumption at 24 Hours Postoperatively | 5.75 mg |
| Ultrasound Assisted Paravertebral Nerve Block | Opioid Consumption at 24 Hours Postoperatively | 6.38 mg |
p-value: 0.643t-test, 2 sided
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).
Time frame: Preoperatively and postoperatively
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Forced Expiratory Volume in 1 Sec (FEV1) | 0.561 percentage in change from per-surgery |
| Ultrasound Assisted Paravertebral Nerve Block | Forced Expiratory Volume in 1 Sec (FEV1) | 0.571 percentage in change from per-surgery |
p-value: 0.913t-test, 2 sided
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).
Time frame: Preoperatively and postoperatively
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Forced Vital Capacity (FVC) | 0.551 percentage in change from per-surgery |
| Ultrasound Assisted Paravertebral Nerve Block | Forced Vital Capacity (FVC) | 0.504 percentage in change from per-surgery |
p-value: 0.574t-test, 2 sided
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).
Time frame: Preoperatively and Postoperatively
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Incentive Spirometry | 0.658 percentage in change from per-surgery |
| Ultrasound Assisted Paravertebral Nerve Block | Incentive Spirometry | 0.716 percentage in change from per-surgery |
p-value: 0.487t-test, 2 sided
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.
Time frame: Pre-operatively and at 24 hour post-operative
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2) | 95 Percentage of SpO2 |
| Ultrasound Assisted Paravertebral Nerve Block | Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2) | 94 Percentage of SpO2 |
p-value: 0.308t-test, 2 sided
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.
Time frame: 24 hours postoperatively
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Number of Local Anesthetic Boluses Requested by PCA | 27.5 Number of boluses requested |
| Ultrasound Assisted Paravertebral Nerve Block | Number of Local Anesthetic Boluses Requested by PCA | 48 Number of boluses requested |
p-value: 0.605t-test, 2 sided
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.
Time frame: 24 hours post PCA initiation
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing | NRS at rest after 24 hrs | 1.73 units on a scale |
| Traditional Approach Paravertebral Nerve Block | Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing | NRS during deep inspiration at 24 hrs | 4 units on a scale |
| Ultrasound Assisted Paravertebral Nerve Block | Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing | NRS at rest after 24 hrs | 2.92 units on a scale |
| Ultrasound Assisted Paravertebral Nerve Block | Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing | NRS during deep inspiration at 24 hrs | 4.77 units on a scale |
Comparison: This p-value is calculated for the NRS at rest.p-value: 0.077t-test, 2 sided
Comparison: This p-value is calculated for the NRS during deep inspiration at 24 hrs.p-value: 0.39t-test, 2 sided
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).
Time frame: Preoperatively and postoperatively
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Peak Expiratory Flow Rate(PEF) | 0.568 percentage in change from per-surgery |
| Ultrasound Assisted Paravertebral Nerve Block | Peak Expiratory Flow Rate(PEF) | 0.542 percentage in change from per-surgery |
p-value: 0.783t-test, 2 sided
Secondary
Respiratory Rate
Respiratory rate (RR) per minute after surgery.
Time frame: 24 hours postoperatively
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Respiratory Rate | 17 breaths per one minute |
| Ultrasound Assisted Paravertebral Nerve Block | Respiratory Rate | 17.7 breaths per one minute |
p-value: 0.493t-test, 2 sided
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.
Time frame: 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Sensory Level | 3 Participants |
| Ultrasound Assisted Paravertebral Nerve Block | Sensory Level | 1 Participants |
Secondary
Total Local Anesthetic Infusions Over 24- Hour Period
The total local anesthetic infusions over 24- hour period.
Time frame: 24 hours postoperatively
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Total Local Anesthetic Infusions Over 24- Hour Period | 173 mL |
| Ultrasound Assisted Paravertebral Nerve Block | Total Local Anesthetic Infusions Over 24- Hour Period | 186 mL |
Comparison: This p-value is for the Local Anesthetic infused in 24 hrs.p-value: 0.104t-test, 2 sided
Secondary
Total Number of Local Anesthetic Boluses in 24 Hours
Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.
Time frame: postoperatively, up to 24 hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Approach Paravertebral Nerve Block | Total Number of Local Anesthetic Boluses in 24 Hours | 1 number of boluses |
| Ultrasound Assisted Paravertebral Nerve Block | Total Number of Local Anesthetic Boluses in 24 Hours | 2 number of boluses |