Skip to content

Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.

Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03151434
Acronym
VATS
Enrollment
147
Registered
2017-05-12
Start date
2017-02-07
Completion date
2018-07-30
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute, Pain, Postoperative, Video Assisted Thoracoscopic Surgery

Keywords

VATS, pain

Brief summary

The purpose of this study is to compare three different pain control methods on subjects who are scheduled to undergo VATS (video-assisted thoracoscopic surgery) procedures. The study will compare their pain scores, narcotic needs, patient satisfaction scores, and narcotic side effects.

Detailed description

All patients will be consented on the morning of surgery. All the thoracic epidurals and ultrasound-guided paravertebral blocks will be placed preoperatively. The procedures will be done using sterile technique with masks, hats, and sterile gloves. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room. Thoracic epidurals will be placed using the Arrow thoracic epidural kit. The epidural will be placed at the appropriate level to cover the entry site for the VATS procedure. Placement will be determined by anatomical landmarks. The epidural needle will be advanced toward the epidural space utilizing a Paramedian approach and loss-of-resistance technique. A sterile catheter will then be secured in place and the epidural infusion will be started at the end of the case. Ultrasound guided paravertebral catheter and single shot paravertebral block will be accomplished using an ultrasound transducer at the thoracic level. This will be done using an in-plane or out-of-plane approach, at the discretion of the anesthesia staff performing the procedure. Then a needle will be inserted the needle into the paravertebral space and local anesthetic injected. Then a catheter will be placed within the injectate and secured in place in the case of the paravertebral catheter. The 0.2% Ropivicaine will be delivered by OnQ pump. General anesthesia will be induced and the patient will be placed in the lateral position for the VATS procedure. The patients will be intubated with dual lumen endotracheal tubes and placed on one-lung ventilation for the procedure. All patients will receive intravenous patient-controlled analgesia (PCA hydromorphone) post-operatively for breakthrough pain. They will also be scheduled on PO acetaminophen. PO oxycodone PRN will be started on POD 1 once patients tolerate diet. Opioid usage at 1,24,48,72 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the epidural or PVB. Patients will be encouraged to ambulate on postoperative day 1 under supervision. All catheters will be removed by APS (Acute Pain Service) while patients are still in the hospital. APS will continue to follow the patients until catheter removal. Patient's hospital length of stay and readmission rate will be recorded from NSQIP (National Surgical Quality Improvement Program) data. All patients will receive a phone call 6 months after surgery for assessment for chronic post-surgical pain. Patients will be assessed by a member of the research team over the phone. They will be assessed on their pain score and narcotic usage by using the Brief Pain Inventory. Study participation will conclude after the 6 month follow questionnaire has been completed.

Interventions

DRUGUS Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion)

Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.

DRUGUS Guided Paravertebral Catheter (0.2% ropivicaine bolus)

Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.

DRUGThoracic Epidural (0.125% bupivicaine/hydromorphone)

Epidural catheter will be placed in the thoracic region prior to surgery.

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients randomized to epidural, single shot paravertebral block, and paravertebral catheter

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Pt undergoing VATS procedure at Indiana University Hospital * ASA 1,2,3 or 4 * Age 18 or older, male or female * Desires Regional anesthesia for postoperative pain control

Exclusion criteria

* Any contraindication for Thoracic Epidural or Paravertebral block * History of substance abuse in the past 6 months * Patient staying intubated after surgery * Known allergy or other contraindications to the study medications , which include dilaudid, bupivacaine, ropivacaine

Design outcomes

Primary

MeasureTime frameDescription
The Primary Endpoint of This Study Will be VAS Pain Score at 24 HoursPain scores will be measured 24 hours after surgery.The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using units on a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
The Primary Endpoint of This Study Will be VAS Pain Score at 48 HoursPain scores will be measured 48 hours after surgery.The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Usingunits on a scale scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

Secondary

MeasureTime frameDescription
Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 HoursOpioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements

Other

MeasureTime frameDescription
Subjects Overall Satisfaction Scorespost operatively at hour 24Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
Average Nausea Scores Over 72 HoursNausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as 0=none, 1=mild, 2=moderate, or 3=severe
Average Sedation Scores Over 72 HoursSedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep.

Countries

United States

Participant flow

Participants by arm

ArmCount
US Guided Single Shot Paravertebral Block
group 1- US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
40
US Guided Paravertebral Catheter
group 2- US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
40
Thoracic Epidural
group 3- Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
40
Total120

Baseline characteristics

CharacteristicUS Guided Single Shot Paravertebral BlockTotalThoracic EpiduralUS Guided Paravertebral Catheter
Age, Continuous63.5 years62 years61 years62 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
40 Participants120 Participants40 Participants40 Participants
height171 Centimeter170 Centimeter173.5 Centimeter167.6 Centimeter
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
8 Participants13 Participants1 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants3 Participants0 Participants3 Participants
Race (NIH/OMB)
White
32 Participants104 Participants39 Participants33 Participants
Region of Enrollment
United States
40 Participants120 Participants40 Participants40 Participants
Sex: Female, Male
Female
24 Participants60 Participants15 Participants21 Participants
Sex: Female, Male
Male
16 Participants60 Participants25 Participants19 Participants
weight88.4 Kilogram84.1 Kilogram87.3 Kilogram77.7 Kilogram

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 400 / 400 / 40
other
Total, other adverse events
0 / 400 / 400 / 40
serious
Total, serious adverse events
0 / 400 / 400 / 40

Outcome results

Primary

The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours

The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using units on a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

Time frame: Pain scores will be measured 24 hours after surgery.

ArmMeasureValue (MEDIAN)
US Guided Single Shot Paravertebral BlockThe Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours4.0 units on a scale
US Guided Paravertebral CatheterThe Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours4.5 units on a scale
Thoracic EpiduralThe Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours3.0 units on a scale
Primary

The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours

The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Usingunits on a scale scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

Time frame: Pain scores will be measured 48 hours after surgery.

ArmMeasureValue (MEDIAN)
US Guided Single Shot Paravertebral BlockThe Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours3.0 units on a scale
US Guided Paravertebral CatheterThe Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours4.0 units on a scale
Thoracic EpiduralThe Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours2.0 units on a scale
Secondary

Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours

Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements

Time frame: Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.

ArmMeasureValue (MEDIAN)
US Guided Single Shot Paravertebral BlockSecondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours57 miligram morphine equivalent
US Guided Paravertebral CatheterSecondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours35 miligram morphine equivalent
Thoracic EpiduralSecondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours21.3 miligram morphine equivalent
Other Pre-specified

Average Nausea Scores Over 72 Hours

Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as 0=none, 1=mild, 2=moderate, or 3=severe

Time frame: Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.

ArmMeasureValue (MEAN)
US Guided Single Shot Paravertebral BlockAverage Nausea Scores Over 72 Hours0.27 units on a scale
US Guided Paravertebral CatheterAverage Nausea Scores Over 72 Hours0.27 units on a scale
Thoracic EpiduralAverage Nausea Scores Over 72 Hours0.29 units on a scale
Other Pre-specified

Average Sedation Scores Over 72 Hours

Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep.

Time frame: Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.

ArmMeasureValue (MEAN)
US Guided Single Shot Paravertebral BlockAverage Sedation Scores Over 72 Hours0.38 units on a scale
US Guided Paravertebral CatheterAverage Sedation Scores Over 72 Hours0.32 units on a scale
Thoracic EpiduralAverage Sedation Scores Over 72 Hours0.22 units on a scale
Other Pre-specified

Subjects Overall Satisfaction Scores

Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.

Time frame: post operatively at hour 24

ArmMeasureValue (MEAN)
US Guided Single Shot Paravertebral BlockSubjects Overall Satisfaction Scores0.89 units on a scale
US Guided Paravertebral CatheterSubjects Overall Satisfaction Scores0.95 units on a scale
Thoracic EpiduralSubjects Overall Satisfaction Scores1.33 units on a scale
Other Pre-specified

Subjects Overall Satisfaction Scores

Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. Scores will be recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.

Time frame: post operatively at hour 48

ArmMeasureValue (MEAN)
US Guided Single Shot Paravertebral BlockSubjects Overall Satisfaction Scores1.19 units on a scale
US Guided Paravertebral CatheterSubjects Overall Satisfaction Scores1.05 units on a scale
Thoracic EpiduralSubjects Overall Satisfaction Scores1.32 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026