Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.
Status: | Recruiting |
---|---|
Conditions: | Post-Surgical Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/2/2019 |
Start Date: | February 7, 2017 |
End Date: | December 30, 2019 |
Contact: | Yar Yeap, MD |
Email: | yyeap@iupui.edu |
Phone: | 317-274-0275 |
Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery
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.
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.
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.
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.
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
We found this trial at
1
site
550 University Boulevard
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Phone: 317-274-0275
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