Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | February 24, 2017 |
| End Date: | September 20, 2018 |
The moderate-to-severe pain many patients experience following orthopedic surgery is often
treated with opioids, which are associated with side effects such as nausea/vomiting,
sedation, and respiratory depression (and a risk of abuse). Potent site-specific analgesia
with fewer side effects may be provided with a "continuous peripheral nerve block," which
involves the percutaneous insertion of a catheter adjacent to the peripheral nerve(s)
supplying a surgical site. Local anesthetic is introduced via the catheter. However, there
are major problems with continuous nerve blocks that have dramatically limited their use
outside academic centers. Percutaneous peripheral nerve stimulation (PNS) or "nerve
modulation" is an alternative method of pain control involving the insertion of an electrical
lead through an introducing needle—obviating an open surgical incision for placement—followed
by the introduction of electric current to produce analgesia. This modality has been used to
treat chronic pain, but it has not been evaluated with a randomized, controlled study when
applied to acute pain management (post-surgical analgesia). This temporary therapy has
multiple theoretical benefits over existing analgesics, such as a lack of systemic side
effects (e.g., nausea, respiratory depression), an absence of induced muscle weakness, and a
reduced risk of adverse events (e.g. infection). The purpose of the proposed randomized,
double-masked, placebo-controlled, crossover, feasibility study is to explore the possibility
of treating postoperative pain with ultrasound-guided percutaneous PNS and, if so, to help
power a subsequent definitive randomized, controlled trial.
treated with opioids, which are associated with side effects such as nausea/vomiting,
sedation, and respiratory depression (and a risk of abuse). Potent site-specific analgesia
with fewer side effects may be provided with a "continuous peripheral nerve block," which
involves the percutaneous insertion of a catheter adjacent to the peripheral nerve(s)
supplying a surgical site. Local anesthetic is introduced via the catheter. However, there
are major problems with continuous nerve blocks that have dramatically limited their use
outside academic centers. Percutaneous peripheral nerve stimulation (PNS) or "nerve
modulation" is an alternative method of pain control involving the insertion of an electrical
lead through an introducing needle—obviating an open surgical incision for placement—followed
by the introduction of electric current to produce analgesia. This modality has been used to
treat chronic pain, but it has not been evaluated with a randomized, controlled study when
applied to acute pain management (post-surgical analgesia). This temporary therapy has
multiple theoretical benefits over existing analgesics, such as a lack of systemic side
effects (e.g., nausea, respiratory depression), an absence of induced muscle weakness, and a
reduced risk of adverse events (e.g. infection). The purpose of the proposed randomized,
double-masked, placebo-controlled, crossover, feasibility study is to explore the possibility
of treating postoperative pain with ultrasound-guided percutaneous PNS and, if so, to help
power a subsequent definitive randomized, controlled trial.
Written, informed consent will be obtained using an IRB-approved ICF prior to any study
procedures. Lead insertion may occur up to 2 weeks prior to surgery within the CTRI, or the
morning of surgery in the regional anesthesia induction area (it just depends on subject and
surgeon preference, as well as logistical issues such as the time of the surgery and
availability of the investigators). Muscle strength will be measured with a pressure
transducer.
Preoperative lead insertion (approximately 1-3 hours). A percutaneous, helically-coiled,
insulated electrical lead will be inserted via an introducer needle at least 2 cm proximal or
distal to the perineural catheter location along the target nerve using real-time ultrasound
guidance:
Surgical Procedure Location: Perineural Catheter Location, Electrical Lead Location
Shoulder: Interscalene, Interscalene or supraclavicular or suprascapular
At or distal to the elbow: Infraclavicular, Interscalene, supraclavicular or terminal
nerve(s)
Foot or ankle: Popliteal-sciatic [adductor canal optional], Subgluteal-sciatic [femoral
optional]
Knee or distal thigh: Adductor canal [popliteal-sciatic optional], Femoral
[subgluteal-sciatic optional]
It will be optional for a conducting probe to be used prior to lead insertion—this allows
identification of the optimal lead tip location relative to the target nerve by passing
electrical current via the insulated probe. The desired end point is a pleasant paresthesia
in the distribution of the target nerve reported by the subject. If used, the probe will be
completely withdrawn following target location identification, and a lead subsequently
inserted to the target location. Following needle removal, the percutaneous helical lead will
have electric current passed using the SPRINT (SPR Therapeutics, Cleveland, OH) pulse
generator to ensure accurate placement (a pleasant paresthesia in the distribution of the
target nerve). It will be replaced, if necessary. Muscle strength will be measured with a
pressure transducer during the delivery of electrical current. The pulse generator will then
be removed and the lead affixed to the skin using an occlusive dressing.
With the subject's permission the investigators may photograph or videotape the procedures
described above for educational, training, or publication purposes. The photos or video will
focus only on the lead insertion site and affected limb. Ultrasound images from the procedure
may also be collected. Every effort will be made to protect the subject's privacy and the
photos or video will not include the subject's face or any other personal identifiers such as
birthmarks. Subjects and their caretakers will be trained in device care and management, and
given written instructions as well. Following successful lead insertion, a perineural
catheter may be inserted, if the patient desires a catheter (with normal saline injection and
not local anesthetic via the inserting needle). This will be used to deliver perineural local
anesthetic as a rescue analgesic method postoperatively in case the SPRINT system provides
inadequate analgesia.
Randomization. Within the recovery room, the surgeon often performs a standard neurologic
examination (variable depending on the surgeon and surgical procedure), after which time the
subject will have baseline end points measured, including a pain score at the surgical site
using the Numeric Rating Scale (NRS, 0-10), pain score (NRS) within the target nerve
distribution, and sensory deficits (measured with alcohol pads and von Frey filaments
compared to the contralateral limb within the cutaneous distribution of the target nerve).
For their first pulse generator—"Stimulator A"—subjects will be randomized to one of two
treatments—current or sham—using computer generated lists and opaque, sealed envelopes. The
stimulator will then be attached to the lead and switched "on" (sham stimulator produces no
current). The end points will be measured per the table below. Subsequently, the stimulator
will be replaced by the alternative (current or sham)—"Stimulator B". The subject will have
the end points measured and the stimulator replaced with a unit set to deliver active current
for the remainder of study participation ("Stimulator C"). Operating and recovery room
pharmacologic analgesic requirements will be recorded. Of note, if a lead fails to provide
paresthesias within the target nerve distribution with either Stimulator A or B (adjustment
of stimulator settings allowed), the lead may be replaced at the discretion of the subject
and investigators.
End point collection (first day within the recovery room; approximately 30 minutes):
Baseline, then stimulator A is activated (sham or real) Minutes 1-5, then stimulator B is
activated (sham or real) Minutes 1-5, then stimulator C is activated (always real) Minute 5
and 30 within the recovery room Daily x 14 days Months 1 and 3
Endpoints will include the numeric rating scale for pain (NRS) at the surgical site at rest
and with movement, the lead-related NRS (pain at lead site), muscle strength, sensory
deficits, and the question "adequate analgesia?" as a nominal response of yes or no.
Of note, the data derived from the chronic pain literature suggests that there is a "carry
over" effect following stimulation: analgesia is provided even after the cessation of
electrical current. It remains unknown if this is true following surgery in the acute
postoperative pain period. For subjects randomized to active current from Stimulator A, the
data collected for Stimulator B placebo treatment may be lowered due to the carry over
effect. Therefore, this data will not be compared with the baseline or Stimulator A outcome
measures. However, it is valuable data to possibly detect and quantify the carry-over effect
of the initial stimulation.
At any time, subjects may choose to have their perineural catheter bolused with local
anesthetic and a perineural local anesthetic infusion begun (if they desired a catheter with
subsequent insertion). Therefore, subjects will not risk receiving inferior analgesia by
participating in this study. However, subjects also have the option of leaving their infusion
pump off and using neuromodulation as their primary analgesic if the latter proves
adequate—the decision is completely each subject's and may be made any time prior to
perineural catheter removal.
Subjects and their caretakers will be trained in device care and management, and given
written instructions as well. Pain scores (resting and dynamic worst and average) will be
collected daily for two weeks, along with oral analgesic requirements, perineural local
anesthetic use, and sensory/motor deficits (all specific to the previous 24 hours).
Perineural catheters will be removed at home upon subject request, after 3 days, or upon
local anesthetic reservoir exhaustion, whichever comes first (standard-of-care). The
electrical leads will be removed upon subject request, or after 30 days, whichever comes
first. The leads will be removed at home by subjects or their caretakers (standard-of-care
for perineural catheter withdrawal) or by investigators, depending on both investigator and
subject preference. If removed by subjects or their caretakers, a picture of the extracted
lead tip must be texted/emailed to investigators, or the physical lead returned to
investigators for inspection. Subjects will be contacted no less than every 5 days following
the initial 2-week period until their lead is removed; and, will then be contacted 1 and 3
months postoperatively and the end points again verbally collected.
procedures. Lead insertion may occur up to 2 weeks prior to surgery within the CTRI, or the
morning of surgery in the regional anesthesia induction area (it just depends on subject and
surgeon preference, as well as logistical issues such as the time of the surgery and
availability of the investigators). Muscle strength will be measured with a pressure
transducer.
Preoperative lead insertion (approximately 1-3 hours). A percutaneous, helically-coiled,
insulated electrical lead will be inserted via an introducer needle at least 2 cm proximal or
distal to the perineural catheter location along the target nerve using real-time ultrasound
guidance:
Surgical Procedure Location: Perineural Catheter Location, Electrical Lead Location
Shoulder: Interscalene, Interscalene or supraclavicular or suprascapular
At or distal to the elbow: Infraclavicular, Interscalene, supraclavicular or terminal
nerve(s)
Foot or ankle: Popliteal-sciatic [adductor canal optional], Subgluteal-sciatic [femoral
optional]
Knee or distal thigh: Adductor canal [popliteal-sciatic optional], Femoral
[subgluteal-sciatic optional]
It will be optional for a conducting probe to be used prior to lead insertion—this allows
identification of the optimal lead tip location relative to the target nerve by passing
electrical current via the insulated probe. The desired end point is a pleasant paresthesia
in the distribution of the target nerve reported by the subject. If used, the probe will be
completely withdrawn following target location identification, and a lead subsequently
inserted to the target location. Following needle removal, the percutaneous helical lead will
have electric current passed using the SPRINT (SPR Therapeutics, Cleveland, OH) pulse
generator to ensure accurate placement (a pleasant paresthesia in the distribution of the
target nerve). It will be replaced, if necessary. Muscle strength will be measured with a
pressure transducer during the delivery of electrical current. The pulse generator will then
be removed and the lead affixed to the skin using an occlusive dressing.
With the subject's permission the investigators may photograph or videotape the procedures
described above for educational, training, or publication purposes. The photos or video will
focus only on the lead insertion site and affected limb. Ultrasound images from the procedure
may also be collected. Every effort will be made to protect the subject's privacy and the
photos or video will not include the subject's face or any other personal identifiers such as
birthmarks. Subjects and their caretakers will be trained in device care and management, and
given written instructions as well. Following successful lead insertion, a perineural
catheter may be inserted, if the patient desires a catheter (with normal saline injection and
not local anesthetic via the inserting needle). This will be used to deliver perineural local
anesthetic as a rescue analgesic method postoperatively in case the SPRINT system provides
inadequate analgesia.
Randomization. Within the recovery room, the surgeon often performs a standard neurologic
examination (variable depending on the surgeon and surgical procedure), after which time the
subject will have baseline end points measured, including a pain score at the surgical site
using the Numeric Rating Scale (NRS, 0-10), pain score (NRS) within the target nerve
distribution, and sensory deficits (measured with alcohol pads and von Frey filaments
compared to the contralateral limb within the cutaneous distribution of the target nerve).
For their first pulse generator—"Stimulator A"—subjects will be randomized to one of two
treatments—current or sham—using computer generated lists and opaque, sealed envelopes. The
stimulator will then be attached to the lead and switched "on" (sham stimulator produces no
current). The end points will be measured per the table below. Subsequently, the stimulator
will be replaced by the alternative (current or sham)—"Stimulator B". The subject will have
the end points measured and the stimulator replaced with a unit set to deliver active current
for the remainder of study participation ("Stimulator C"). Operating and recovery room
pharmacologic analgesic requirements will be recorded. Of note, if a lead fails to provide
paresthesias within the target nerve distribution with either Stimulator A or B (adjustment
of stimulator settings allowed), the lead may be replaced at the discretion of the subject
and investigators.
End point collection (first day within the recovery room; approximately 30 minutes):
Baseline, then stimulator A is activated (sham or real) Minutes 1-5, then stimulator B is
activated (sham or real) Minutes 1-5, then stimulator C is activated (always real) Minute 5
and 30 within the recovery room Daily x 14 days Months 1 and 3
Endpoints will include the numeric rating scale for pain (NRS) at the surgical site at rest
and with movement, the lead-related NRS (pain at lead site), muscle strength, sensory
deficits, and the question "adequate analgesia?" as a nominal response of yes or no.
Of note, the data derived from the chronic pain literature suggests that there is a "carry
over" effect following stimulation: analgesia is provided even after the cessation of
electrical current. It remains unknown if this is true following surgery in the acute
postoperative pain period. For subjects randomized to active current from Stimulator A, the
data collected for Stimulator B placebo treatment may be lowered due to the carry over
effect. Therefore, this data will not be compared with the baseline or Stimulator A outcome
measures. However, it is valuable data to possibly detect and quantify the carry-over effect
of the initial stimulation.
At any time, subjects may choose to have their perineural catheter bolused with local
anesthetic and a perineural local anesthetic infusion begun (if they desired a catheter with
subsequent insertion). Therefore, subjects will not risk receiving inferior analgesia by
participating in this study. However, subjects also have the option of leaving their infusion
pump off and using neuromodulation as their primary analgesic if the latter proves
adequate—the decision is completely each subject's and may be made any time prior to
perineural catheter removal.
Subjects and their caretakers will be trained in device care and management, and given
written instructions as well. Pain scores (resting and dynamic worst and average) will be
collected daily for two weeks, along with oral analgesic requirements, perineural local
anesthetic use, and sensory/motor deficits (all specific to the previous 24 hours).
Perineural catheters will be removed at home upon subject request, after 3 days, or upon
local anesthetic reservoir exhaustion, whichever comes first (standard-of-care). The
electrical leads will be removed upon subject request, or after 30 days, whichever comes
first. The leads will be removed at home by subjects or their caretakers (standard-of-care
for perineural catheter withdrawal) or by investigators, depending on both investigator and
subject preference. If removed by subjects or their caretakers, a picture of the extracted
lead tip must be texted/emailed to investigators, or the physical lead returned to
investigators for inspection. Subjects will be contacted no less than every 5 days following
the initial 2-week period until their lead is removed; and, will then be contacted 1 and 3
months postoperatively and the end points again verbally collected.
Inclusion Criteria:
- Undergoing orthopedic surgical procedure that frequently results in moderate-to-severe
postoperative pain
- At least 18 years of age
- Able to understand and willing to take part in study and adhere to all study
requirements
Exclusion Criteria:
- Postoperative analgesic plan includes a single-injection peripheral nerve block in the
surgical extremity
- Chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use
> 4 weeks)
- Known neuro-muscular deficit of the target nerve(s)
- Anticipated MRI within the following 2 weeks
- Compromised immune system based on medical history (e.g., immunosuppressive therapies
such as chemotherapy, radiation, sepsis, infection), or other conditions that places
the subject at increased risk in the opinion of the investigator
- Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain
stimulator, or other implantable neurostimulator whose stimulus current pathway may
overlap
- History of bleeding disorder
- Antiplatelet or anticoagulation therapies other than aspirin
- Allergy to all local anesthetic agents such as lidocaine or previous reaction to
anesthesia
- Allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
- Any other condition that may interfere with ability to participate in a clinical trial
(e.g., anatomy that may interfere with lead placement) as determined by the
Investigators
- Incarceration
- Pregnancy
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