Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters
Study Details
Study Description
Brief Summary
This is a prospective, randomized, controlled, and single blinded study. All work performed at Dartmouth-Hitchcock Medical Center, a tertiary care and level one trauma center for the state of New Hampshire with 28 operative suites. 100 patients scheduled to undergo thoracotomies are randomized to receive an epidural placed (for postoperative pain control) using either a traditional approach by feeling the spine for landmarks or using fluoroscopic X-ray guidance. Randomization is blinded to both the anesthesia team caring for the patient in the operating room and to one member of the acute pain team who follows the patient after surgery and is responsible for evaluating post operative pain control (dermatomal distribution of sensory blockade and visual analog scale) and pulmonary function (incentive spirometer use). All patients receive a standardized epidural infusion with local anesthetic and additional pain medications as needed.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
All epidurals catheters are placed by the Acute Pain Service in the preoperative period in an operating room equipped for fluoroscopy. Patients will have been previously randomized (following written informed consent) to either standard placement of epidural catheters or fluoroscopically-guided placement.
Standard placement (Comparator): According to usual practice, epidurals placed using the standard technique will be placed in the sitting position using a 'loss of resistance' technique. This technique involves approximation of the T7 vertebral body through palpation of the distal aspect of the scapula and identification of midline through palpation of the spinous processes. The skin is then anesthetized with 1% Lidocaine and an 18 gauge Tuohy needle is inserted until there is engagement with the supraspinous and interspinous ligaments. A glass syringe filled with saline and air is then attached to the Tuohy needle, which is slowly advanced until the epidural space is identified with loss of resistance to injection in the glass syringe. The glass syringe is then detached from the Tuohy needle and the epidural catheter is threaded approximately 3-4 cm into the epidural space. The catheter will then be aspirated using a 3ml syringe to confirm that it has not been place in the intravascular or intrathecal space. Five ml of radiopaque dye (omnipaque) will be injected and a single image taken and stored on disc but not read by a clinician. A test dose of 3ml of 1.5% Lidocaine with epinephrine will then be injected to ensure that the catheter is not intravascular.
Fluoroscopically guided epidural placement (Experimental): Patients will be placed in the prone position. Identification of an appropriate interspace (T7-T12) and midline orientation will be accomplished using fluoroscopic guidance. The skin will then be anesthetized and the epidural space identified using the loss of resistance as described above. Fluoroscopy will be used during identification of the epidural space to confirm midline orientation during advancement of the Tuohy needle. Once the epidural space is identified, the epidural catheter will be advanced to the T4 level. The catheter will then be aspirated as above. 5cc of Omnipaque will be injected into the catheter with anterior-posterior and lateral imaging to ensure expected spread of the dye as confirmation of correct placement in the epidural space. The catheter will then be bolused with 3cc of 1.5% lidocaine with epinephrine to ensure that the catheters are not placed intravascularly.
Following epidural placement via either technique, patients will then be transferred to the surgical operating room where an infusion of 1/8% Bupivicaine will be started at a rate of 4ml/hr. This epidural infusion will continue throughout the case. Titration of this infusion will be guided by clinical judgment of the primary anesthesia team in the operating room between the range of 0-14 ml/hr with primary assessments including the patient's analgesic requirement and hemodynamic stability.
Intraoperative period: A standardized anesthesia induction and maintenance protocol will be used. This protocol will include sedation with 2mg of midazolam and fentanyl (1-2mcg/kg) for epidural placement, 2-3 μg/kg fentanyl prior to induction, 2-2.5mg/kg propofol on induction and isoflurane for maintenance of anesthesia. Additional narcotic administration is at the discretion of the primary anesthesia team but recommended for patients up to their daily opiate dose, plus an additional 0.1mg/kg morphine at or before emergence. Ketorolac 15mg may be administered as clinically indicated unless contraindications such as age >75, renal insufficiency (gfr <60) or surgeon preference. In addition, 4mg dexamethasone will be administered on induction. Nitrous oxide and ketamine will not be used. Hemodynamic monitoring will be accomplished with standard monitors, an arterial line placed by the primary anesthesia team, and, if indicated, noninvasive cardiac outcome monitors. The arterial line will be placed according to the preference of the primary anesthesia team.
Postoperative period: Post operative pain management will be dictated by the primary surgical service. Typical management includes patient-controlled analgesia of IV morphine, fentanyl or hydromorphone with transition to oral medications as indicated on post operative day one. Titration of the epidural between the 4cc/hr up to a maximum of 14cc/hr will be made based upon a specific protocol for inadequate pain relief. The epidural will be bolused with 4cc from the standard solution and then the rate of the infusion will be increased by 2cc/hr if and when a patient requires better analgesia. If the epidural is deemed non functioning by the supervising attending on the pain service, as evidence by a lack of sensory blockade in the distribution of the incision and patient discomfort, then it is at the discretion of the acute pain service attending to remove or replace the non-functional epidural.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fluoroscopy Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter in the spinal epidural space at the desired location. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. |
Device: Fluoroscopy
Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr
|
| Active Comparator: Traditional The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. |
Procedure: Traditional
An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Intravenous Pain Medication [24 hours after surgery]
Outcome measure is mg of morphine equivalent used in first 24 hours after surgery: Postoperative pain medication use during the first 24 postoperative hours will be calculated by converting medication to an equivalent amount of morphine. This is an indirect measure of postoperative pain.
Secondary Outcome Measures
- Incidence of Epidural Catheter Failure [24 hours after surgery]
Percent of epidural catheters that were correctly placed (percentage of catheters).
- Postoperative Pain Intensity Measured by Numeric Scale [Measured at 24 hours after surgery]
Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).
- Postoperative Pain Intensity Measured by Numeric Scale [Measured at 48 hours after surgery]
Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).
- Postoperative Pain Intensity Measured by Numeric Scale [3 months after surgery during follow up office visit with surgeon]
Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient scheduled for open thoracotomy procedure
-
Patient provides informed consent
Exclusion Criteria:
-
Age less than 19
-
Pregnancy
-
Contraindication to an epidural catheter placement bleeding disorder cardiac valve stenosis systemic infection spinal abnormality
-
Allergy to local anesthetics or X-ray dye
-
Patient refusal to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CPHS#23226
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Traditional | Fluoroscopy |
|---|---|---|
| Arm/Group Description | The traditional approach for placement of an epidural catheter is indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter for pain control. Traditional: An epidural catheter is placed before surgery with the patient sitting. The catheter is placed using indirect indicators of placement: depth of needle and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle and the needle removed. After catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected to exclude intravascular placement. A continuous infusion of 1/8% bupivacaine is started at 4ml/hr. The bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr. | Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter in the epidural space at the desired location. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. The bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr |
| Period Title: Overall Study | ||
| STARTED | 53 | 47 |
| COMPLETED | 53 | 47 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Fluoroscopy | Traditional | Total |
|---|---|---|---|
| Arm/Group Description | Real-time fluoroscopic X-ray guidance to confirm placement of epidural catheter in the epidural space at the desired location. Following epidural catheter placement 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr | The traditional approach for placement of an epidural catheter is with indirect indicators including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control. Traditional: An epidural catheter is placed before surgery with the patient sitting. The catheter is placed using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement, an epidural catheter is threaded through the needle and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected to exclude intravascular placement. A continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr. | Total of all reporting groups |
| Overall Participants | 47 | 53 | 100 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
25
53.2%
|
34
64.2%
|
59
59%
|
| >=65 years |
22
46.8%
|
19
35.8%
|
41
41%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
65.2
(10.6)
|
64.9
(8.9)
|
65.1
(10.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
22
46.8%
|
29
54.7%
|
51
51%
|
| Male |
25
53.2%
|
24
45.3%
|
49
49%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
47
100%
|
53
100%
|
100
100%
|
Outcome Measures
| Title | Intravenous Pain Medication |
|---|---|
| Description | Outcome measure is mg of morphine equivalent used in first 24 hours after surgery: Postoperative pain medication use during the first 24 postoperative hours will be calculated by converting medication to an equivalent amount of morphine. This is an indirect measure of postoperative pain. |
| Time Frame | 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fluoroscopy | Traditional |
|---|---|---|
| Arm/Group Description | Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi | The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b |
| Measure Participants | 47 | 53 |
| Mean (Standard Deviation) [milligrams] |
63
(33)
|
66
(27)
|
| Title | Incidence of Epidural Catheter Failure |
|---|---|
| Description | Percent of epidural catheters that were correctly placed (percentage of catheters). |
| Time Frame | 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fluoroscopy | Traditional |
|---|---|---|
| Arm/Group Description | Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi | The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b |
| Measure Participants | 47 | 53 |
| Number [percentage of catheters] |
74
|
98
|
| Title | Postoperative Pain Intensity Measured by Numeric Scale |
|---|---|
| Description | Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain). |
| Time Frame | Measured at 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fluoroscopy | Traditional |
|---|---|---|
| Arm/Group Description | Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi | The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b |
| Measure Participants | 47 | 53 |
| Mean (Standard Deviation) [units on a scale of 0 to 10] |
6.3
(3.1)
|
6.6
(3.4)
|
| Title | Postoperative Pain Intensity Measured by Numeric Scale |
|---|---|
| Description | Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain). |
| Time Frame | Measured at 48 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fluoroscopy | Traditional |
|---|---|---|
| Arm/Group Description | Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi | The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b |
| Measure Participants | 47 | 53 |
| Mean (Standard Deviation) [milligrams] |
6.4
(3.3)
|
6.8
(2.7)
|
| Title | Postoperative Pain Intensity Measured by Numeric Scale |
|---|---|
| Description | Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain). |
| Time Frame | 3 months after surgery during follow up office visit with surgeon |
Outcome Measure Data
| Analysis Population Description |
|---|
| Insufficient data were collected for this analysis |
| Arm/Group Title | Fluoroscopy | Traditional |
|---|---|---|
| Arm/Group Description | Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi | The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Fluoroscopy | Traditional | ||
| Arm/Group Description | Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr | The traditional approach for placement of an epidural catheter is used with indirect indicators of placement. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control. Traditional: An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement, an epidural catheter is threaded through the needle and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr . | ||
All Cause Mortality |
||||
| Fluoroscopy | Traditional | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Fluoroscopy | Traditional | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/47 (0%) | 0/53 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Fluoroscopy | Traditional | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/47 (0%) | 0/53 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Mark P. Yeager, MD |
|---|---|
| Organization | Dartmouth-Hitchcock |
| Phone | 603-650-5922 |
| mark.p.yeager@hitchcock.org |
- CPHS#23226