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Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters

Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02678039
Enrollment
100
Registered
2016-02-09
Start date
2012-08-31
Completion date
2014-05-31
Last updated
2017-09-12

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

Conditions

Pain, Postoperative, Pain, Chronic

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.

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.

Interventions

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

PROCEDURETraditional

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.

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Intravenous Pain Medication24 hours after surgeryOutcome 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

MeasureTime frameDescription
Incidence of Epidural Catheter Failure24 hours after surgeryPercent of epidural catheters that were correctly placed (percentage of catheters).
Postoperative Pain Intensity Measured by Numeric ScaleMeasured at 24 hours after surgeryAssessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).

Countries

United States

Participant flow

Participants by arm

ArmCount
Fluoroscopy
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
47
Traditional
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.
53
Total100

Baseline characteristics

CharacteristicTraditionalFluoroscopyTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
19 Participants22 Participants41 Participants
Age, Categorical
Between 18 and 65 years
34 Participants25 Participants59 Participants
Age, Continuous64.9 years
STANDARD_DEVIATION 8.9
65.2 years
STANDARD_DEVIATION 10.6
65.1 years
STANDARD_DEVIATION 10.2
Region of Enrollment
United States
53 participants47 participants100 participants
Sex: Female, Male
Female
29 Participants22 Participants51 Participants
Sex: Female, Male
Male
24 Participants25 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 470 / 53
serious
Total, serious adverse events
0 / 470 / 53

Outcome results

Primary

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.

Time frame: 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
FluoroscopyIntravenous Pain Medication63 milligramsStandard Deviation 33
TraditionalIntravenous Pain Medication66 milligramsStandard Deviation 27
Secondary

Incidence of Epidural Catheter Failure

Percent of epidural catheters that were correctly placed (percentage of catheters).

Time frame: 24 hours after surgery

ArmMeasureValue (NUMBER)
FluoroscopyIncidence of Epidural Catheter Failure74 percentage of catheters
TraditionalIncidence of Epidural Catheter Failure98 percentage of catheters
Secondary

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).

Time frame: 3 months after surgery during follow up office visit with surgeon

Population: Insufficient data were collected for this analysis

Secondary

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).

Time frame: Measured at 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
FluoroscopyPostoperative Pain Intensity Measured by Numeric Scale6.3 units on a scale of 0 to 10Standard Deviation 3.1
TraditionalPostoperative Pain Intensity Measured by Numeric Scale6.6 units on a scale of 0 to 10Standard Deviation 3.4
Secondary

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).

Time frame: Measured at 48 hours after surgery

ArmMeasureValue (MEAN)Dispersion
FluoroscopyPostoperative Pain Intensity Measured by Numeric Scale6.4 milligramsStandard Deviation 3.3
TraditionalPostoperative Pain Intensity Measured by Numeric Scale6.8 milligramsStandard Deviation 2.7

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026