Comparing Through-the-Needle With Suture-Method Catheter Designs for Popliteal Nerve Blocks
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/20/2018 |
| Start Date: | April 6, 2018 |
| End Date: | April 1, 2020 |
A Randomized, Observer-Masked, Controlled, Parallel-Arm, Clinical Trial Comparing Through-the-Needle With Suture-Method Perineural Catheter Designs for Continuous Popliteal-Sciatic Nerve Blocks
Following painful surgical procedures, postoperative analgesia is often provided with a
single-injection peripheral nerve block. Hothe investigatorsver, even with the longest-acting
FDA-approved local anesthetic currently available-bupivacaine-the block duration is measured
in hours, while the surgical pain may persist for days. A continuous peripheral nerve block
allows a prolonged block, consisting of a percutaneously-inserted catheter with its orifice
adjacent to a target nerve/plexus through which local anesthetic may be administered. Two
basic perineural catheter designs currently exist: (1) catheters that are inserted either
through or over a straight hollow-bore needle; and, (2) catheters that are attached to the
back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve
("suture-method" design). To date, a comparison of the relative risks and benefits of these
two designs have not been investigated. The investigators therefore propose a randomized,
observer-masked, controlled, parallel-arm, clinical trial to compare these two catheter
designs when used to provide post-surgical analgesia following foot and ankle surgery.
single-injection peripheral nerve block. Hothe investigatorsver, even with the longest-acting
FDA-approved local anesthetic currently available-bupivacaine-the block duration is measured
in hours, while the surgical pain may persist for days. A continuous peripheral nerve block
allows a prolonged block, consisting of a percutaneously-inserted catheter with its orifice
adjacent to a target nerve/plexus through which local anesthetic may be administered. Two
basic perineural catheter designs currently exist: (1) catheters that are inserted either
through or over a straight hollow-bore needle; and, (2) catheters that are attached to the
back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve
("suture-method" design). To date, a comparison of the relative risks and benefits of these
two designs have not been investigated. The investigators therefore propose a randomized,
observer-masked, controlled, parallel-arm, clinical trial to compare these two catheter
designs when used to provide post-surgical analgesia following foot and ankle surgery.
This investigation will be a randomized, observer-masked, controlled, parallel-arm,
human-subjects clinical trial. Of note, the investigators will be using standard-of-care
perineural catheters and local anesthetic under their FDA-approved purpose and do not plan to
research a possible change of indication or use of these drugs as part of this research
project.
Consenting adults undergoing surgery with a planned popliteal-sciatic perineural catheter
placement will be offered enrollment. Study inclusion will be proposed to eligible patients
prior to surgery. If a patient desires study participation, written, informed consent will be
obtained using a current UCSD IRB-approved ICF.
Following written, informed consent, the investigators will collect baseline anthropomorphic
information (age, sex, height, and the investigatorsight). Subjects will be then be
randomized using a computer-generated list and opaque, sealed envelopes to one of two
treatment groups (blocks of 4, no stratification): perineural catheter insertion using (1)
through-the-needle technique or (2) suture technique. All catheters will be placed by a
regional anesthesia fellow or resident under the direct supervision and guidance of a
regional anesthesia attending (or by the attending him/herself).
All subjects will have a peripheral intravenous (IV) catheter inserted, standard noninvasive
monitors applied, supplemental oxygen administered via a nasal cannula or face mask, and
positioned prone. Midazolam and fentanyl (IV) will be titrated for patient comfort, while
ensuring that patients remain responsive to verbal cues. The area that will be subsequently
covered by the catheter dressing will be clipped of hair, if necessary. The ultrasound will
be placed to visualize the short axis (cross-section) of the sciatic nerve to identify the
sciatic nerve bifurcation which will subsequently be marked, as well as the location 5 cm
cephalad to the bifurcation. The area will be cleaned with chlorhexidine gluconate and
isopropyl alcohol and a clear, sterile, fenestrated drape applied. The ultrasound probe will
be placed to visualize the short-axis (cross-section) of the target nerve(s) and the target
for the catheter to intercept the nerve may be anywhere between the bifurcation and 5 cm
cephalad to the bifurcation. All catheters will be placed using standard UCSD
ultrasound-guided perineural catheter techniques as previously described. Normal saline 5-20
mL will be administered via the needle and/or catheter to allow catheter insertion and/or
testing of catheter location (viewed with ultrasound).
Local anesthetic (20 mL, lidocaine 2% with epinephrine 1:200,000-400,000) will be
administered via the catheter. A "successful" catheter insertion will be defined as
sensory-block onset in the tibial nerve distribution within 30 minutes following the local
anesthetic injection. If the nerve block fails, the catheter will be replaced or the patient
removed from further study.
An infusion pump will be attached to the patient's perineural catheter and initiated within
the recovery room. The pump will provide ropivacaine 0.2% at a 6 mL/h basal rate infusion and
a 4 mL patient-controlled bolus with a 30 minute lockout (standard at UCSD). Subjects will be
discharged with a prescription for oxycodone 5 mg tablets for supplementary analgesia.
Subjects will be contacted via phone for 4 days following surgery to collect study outcome
measures: worst, average, least, and current surgical pain (Numeric Rating Scale of 0 to 10,
with "0" being no pain and "10" being the worst pain ever experienced), analgesic use (oral
opioids and infusion boluses), sleep disturbances, opioid and local anesthetic infusion side
effects, local anesthetic leakage, gross catheter dislodgement, sensory and motor block, and
satisfaction with pain control. Subjects or their caretakers will remove the catheters at
home.
Primary endpoint:
Hypothesis 1: Surgical pain will be noninferior within the first 2 days following foot/ankle
surgery with a suture-method compared with a through-the-needle perineural catheter when used
for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (the mean
"average" pain measured daily with a Numeric Rating Scale).
Hypothesis 2: Opioid consumption will be noninferior within the first 2 days following
foot/ankle surgery with a suture-method compared with a through-the-needle perineural
catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative
analgesia (cumulative dose).
human-subjects clinical trial. Of note, the investigators will be using standard-of-care
perineural catheters and local anesthetic under their FDA-approved purpose and do not plan to
research a possible change of indication or use of these drugs as part of this research
project.
Consenting adults undergoing surgery with a planned popliteal-sciatic perineural catheter
placement will be offered enrollment. Study inclusion will be proposed to eligible patients
prior to surgery. If a patient desires study participation, written, informed consent will be
obtained using a current UCSD IRB-approved ICF.
Following written, informed consent, the investigators will collect baseline anthropomorphic
information (age, sex, height, and the investigatorsight). Subjects will be then be
randomized using a computer-generated list and opaque, sealed envelopes to one of two
treatment groups (blocks of 4, no stratification): perineural catheter insertion using (1)
through-the-needle technique or (2) suture technique. All catheters will be placed by a
regional anesthesia fellow or resident under the direct supervision and guidance of a
regional anesthesia attending (or by the attending him/herself).
All subjects will have a peripheral intravenous (IV) catheter inserted, standard noninvasive
monitors applied, supplemental oxygen administered via a nasal cannula or face mask, and
positioned prone. Midazolam and fentanyl (IV) will be titrated for patient comfort, while
ensuring that patients remain responsive to verbal cues. The area that will be subsequently
covered by the catheter dressing will be clipped of hair, if necessary. The ultrasound will
be placed to visualize the short axis (cross-section) of the sciatic nerve to identify the
sciatic nerve bifurcation which will subsequently be marked, as well as the location 5 cm
cephalad to the bifurcation. The area will be cleaned with chlorhexidine gluconate and
isopropyl alcohol and a clear, sterile, fenestrated drape applied. The ultrasound probe will
be placed to visualize the short-axis (cross-section) of the target nerve(s) and the target
for the catheter to intercept the nerve may be anywhere between the bifurcation and 5 cm
cephalad to the bifurcation. All catheters will be placed using standard UCSD
ultrasound-guided perineural catheter techniques as previously described. Normal saline 5-20
mL will be administered via the needle and/or catheter to allow catheter insertion and/or
testing of catheter location (viewed with ultrasound).
Local anesthetic (20 mL, lidocaine 2% with epinephrine 1:200,000-400,000) will be
administered via the catheter. A "successful" catheter insertion will be defined as
sensory-block onset in the tibial nerve distribution within 30 minutes following the local
anesthetic injection. If the nerve block fails, the catheter will be replaced or the patient
removed from further study.
An infusion pump will be attached to the patient's perineural catheter and initiated within
the recovery room. The pump will provide ropivacaine 0.2% at a 6 mL/h basal rate infusion and
a 4 mL patient-controlled bolus with a 30 minute lockout (standard at UCSD). Subjects will be
discharged with a prescription for oxycodone 5 mg tablets for supplementary analgesia.
Subjects will be contacted via phone for 4 days following surgery to collect study outcome
measures: worst, average, least, and current surgical pain (Numeric Rating Scale of 0 to 10,
with "0" being no pain and "10" being the worst pain ever experienced), analgesic use (oral
opioids and infusion boluses), sleep disturbances, opioid and local anesthetic infusion side
effects, local anesthetic leakage, gross catheter dislodgement, sensory and motor block, and
satisfaction with pain control. Subjects or their caretakers will remove the catheters at
home.
Primary endpoint:
Hypothesis 1: Surgical pain will be noninferior within the first 2 days following foot/ankle
surgery with a suture-method compared with a through-the-needle perineural catheter when used
for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (the mean
"average" pain measured daily with a Numeric Rating Scale).
Hypothesis 2: Opioid consumption will be noninferior within the first 2 days following
foot/ankle surgery with a suture-method compared with a through-the-needle perineural
catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative
analgesia (cumulative dose).
Inclusion Criteria:
- Patients undergoing ambulatory foot or ankle surgery with a popliteal perineural
catheter for postoperative analgesia.
Exclusion Criteria:
- Pregnancy
- Inability to communicate with research staff
- Incarceration
- Clinically apparent neuropathy in the operative extremity
- Chronic high dose opioid use
- History of opioid abuse
- Concurrent surgery outside the block distribution
- Patients with nerves deeper than 5 cm from the skin
We found this trial at
1
site
Click here to add this to my saved trials
