Pain, PostoperativeNCT02678039
Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters
A study testing Fluoroscopy and Traditional in people with Pain, Postoperative and Pain, Chronic, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Pain, Chronic
- What is being tested?
- Fluoroscopy and Traditional
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for open thoracotomy procedure
- Patient provides informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read the 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.
- Conditions
- Pain, Postoperative, Pain, Chronic
- Being tested
- Fluoroscopy, Traditional
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoroscopyDevice
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
TraditionalProcedure or surgery
Also called Loss of resistance
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.
| Study group | Role | What they receive |
|---|---|---|
| Fluoroscopy | Experimental | 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. Receives: Device: Fluoroscopy |
| Traditional | Active comparator | 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. Receives: Procedure: Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous Pain Medication
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.
Measured: 24 hours after surgery
Secondary outcomes (4)
Incidence of Epidural Catheter Failure
Percent of epidural catheters that were correctly placed (percentage of catheters).
Measured: 24 hours after surgery
Postoperative Pain Intensity Measured by Numeric Scale
Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).
Measured: Measured at 24 hours after surgery
Postoperative Pain Intensity Measured by Numeric Scale
Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).
Measured: Measured at 48 hours after surgery
Postoperative Pain Intensity Measured by Numeric Scale
Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).
Measured: 3 months after surgery during follow up office visit with surgeon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startAug 2012
- Primary completionJan 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678039
- Sponsor's protocol ID
- CPHS#23226
- Status last verified
- Aug 2017
- First submitted
- 20 Jan 2016
- Last updated
- 12 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Parra MC, Washburn K, Brown JR, Beach ML, Yeager MP, Barr P, Bonham K, Lamb K, Loftus RW. Fluoroscopic Guidance Increases the Incidence of Thoracic Epidural Catheter Placement Within the Epidural Space: A Randomized Trial. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):17-24. doi: 10.1097/AAP.0000000000000519.
PubMed 27922948
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters
- ClinicalTrials.gov ID
- NCT02678039
- Acronym / sponsor ID
- CPHS#23226
- Conditions
- Pain, Postoperative, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 12 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopy | Experimental | Device: FluoroscopyReal-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. |
| Traditional | Active comparator | Procedure: TraditionalThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient scheduled for open thoracotomy procedure
- Patient provides informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoroscopyDevice: 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 | Device | Fluoroscopy |
| TraditionalAlso: Loss of resistanceAn 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. | Procedure or surgery | Traditional |
Primary outcome
Intravenous Pain Medication
Time frame: 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.
4 secondary outcomes
Incidence of Epidural Catheter Failure
Time frame: 24 hours after surgery
Postoperative Pain Intensity Measured by Numeric Scale
Time frame: Measured at 24 hours after surgery
Postoperative Pain Intensity Measured by Numeric Scale
Time frame: Measured at 48 hours after surgery
Postoperative Pain Intensity Measured by Numeric Scale
Time frame: 3 months after surgery during follow up office visit with surgeon
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27922948Parra MC, Washburn K, Brown JR, Beach ML, Yeager MP, Barr P, Bonham K, Lamb K, Loftus RW. Fluoroscopic Guidance Increases the Incidence of Thoracic Epidural Catheter Placement Within the Epidural Space: A Randomized Trial. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):17-24. doi: 10.1097/AAP.0000000000000519.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoroscopy and Traditional in people with Pain, Postoperative and Pain, Chronic, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravenous Pain Medication (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.