Comparing Through-the-Needle With Suture-Method Catheter Designs for Popliteal Nerve Blocks

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT03442036
• Collaborator: Ferrosan Medical Devices, Roskilde, Denmark (Other)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Regional Anesthesia; Sciatic Nerve Block	Device: Suture-Method Technique; Device: Through-the-Needle Technique	N/A

Detailed Description

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects will be randomized using a computer-generated list and opaque, sealed envelopes to one of two treatment groups (blocks of 4, no stratification): perineural catheter insert using (1) through-the-needle technique or (2) suture technique.Subjects will be randomized using a computer-generated list and opaque, sealed envelopes to one of two treatment groups (blocks of 4, no stratification): perineural catheter insert using (1) through-the-needle technique or (2) suture technique.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 6, 2018
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Through-the-Needle Technique Perineural catheters are inserted through a straight hollow-bore needle. The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.	Device: Through-the-Needle Technique; Perineural catheters are inserted through a straight hollow-bore needle
Experimental: Suture-Method Technique Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve. The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.	Device: Suture-Method Technique; Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve

Outcome Measures

Primary Outcome Measures

1. Average Pain [first two postoperative days combined]

   Pain evaluated using a numeric rating scale with 0 = no pain and 10 = worst imaginable pain

Secondary Outcome Measures

1. Opioid Consumption [first two postoperative days]

   Cumulative opioid consumption (oxycodone) measured in milligrams

2. Worst Pain [Postoperative Days 1 and 2]

   The worst pain score for the day evaluated using a numeric rating scale with 0 = no pain and 10 = worst imaginable pain

Other Outcome Measures

1. Catheter Dislodgment. [first two postoperative days]

   We will also test for noninferiority of the suture method to the through-the-needle perineural catheter on gross catheter dislodgment using a 1-tailed noninferiority test.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Medical Center	San Diego	California	United States	92103

Sponsors and Collaborators

• University of California, San Diego
• Ferrosan Medical Devices, Roskilde, Denmark

Investigators

• Study Director: John J Finneran IV, MD, UC San Diego
• Principal Investigator: Brian M Ilfeld, MD, MS, UC San Diego

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 22, 2018

More Information

Publications

None provided.

• Responsible Party: Brian M. Ilfeld, MD, MS, Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03442036
• Other Study ID Numbers: Suture vs Standard Catheters
• First Posted: Feb 22, 2018
• Last Update Posted: Feb 17, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Brian M. Ilfeld, MD, MS, Professor, University of California, San Diego: Regional Anesthesia; Sciatic Nerve Block; Continuous Nerve Block; Perineural Catheter

Study Results

Participant Flow

Recruitment Details	Subjects undergoing painful foot/ankle surgery at UCSD were recruited to the study. Total enrollment = 70 subjects.

Arm/Group Title	Through-the-Needle Technique	Suture-Method Technique
Arm/Group Description	Perineural catheters were inserted through a straight hollow-bore needle. The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.	Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve. The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
Period Title: Overall Study
STARTED	35	35
COMPLETED	35	35
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Through-the-Needle Technique	Suture-Method Technique	Total
Arm/Group Description	Perineural catheters are inserted through a straight hollow-bore needle. The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control. Through-the-Needle Technique: Perineural catheters are inserted through a straight hollow-bore needle	Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve. The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control. Suture-Method Technique: Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve	Total of all reporting groups
Overall Participants	35	35	70
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	35 100%	26 74.3%	61 87.1%
>=65 years	0 0%	9 25.7%	9 12.9%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	37.5 (12.6)	52.6 (16.8)	45 (16.5)
Sex: Female, Male (Count of Participants)
Female	14 40%	14 40%	28 40%
Male	21 60%	21 60%	42 60%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	35 100%	35 100%	70 100%

Outcome Measures

1. Primary Outcome

Title	Average Pain
Description	Pain evaluated using a numeric rating scale with 0 = no pain and 10 = worst imaginable pain
Time Frame	first two postoperative days combined

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Through-the-Needle Technique	Suture-Method Technique
Arm/Group Description	Perineural catheters were inserted through a straight hollow-bore needle. The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.	Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve. The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
Measure Participants	35	35
Mean (Standard Deviation) [score on a scale]	2.7 (2.4)	3.4 (2.4)

2. Secondary Outcome

Title	Opioid Consumption
Description	Cumulative opioid consumption (oxycodone) measured in milligrams
Time Frame	first two postoperative days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Through-the-Needle Technique	Suture-Method Technique
Arm/Group Description	Perineural catheters were inserted through a straight hollow-bore needle. The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.	Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve. The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
Measure Participants	35	35
Postoperative Day 1	5.0	10
Postoperative Day 2	10	10

3. Secondary Outcome

Title	Worst Pain
Description	The worst pain score for the day evaluated using a numeric rating scale with 0 = no pain and 10 = worst imaginable pain
Time Frame	Postoperative Days 1 and 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Through-the-Needle Technique	Suture-Method Technique
Arm/Group Description	Perineural catheters were inserted through a straight hollow-bore needle. The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.	Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve. The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
Measure Participants	35	35
Postoperative Day 1	5.4 (3.8)	5.8 (3.4)
Postoperative Day 2	5.6 (2.9)	5.6 (3.1)

4. Other Pre-specified Outcome

Title	Catheter Dislodgment.
Description	We will also test for noninferiority of the suture method to the through-the-needle perineural catheter on gross catheter dislodgment using a 1-tailed noninferiority test.
Time Frame	first two postoperative days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Through-the-Needle Technique	Suture-Method Technique
Arm/Group Description	Perineural catheters are inserted through a straight hollow-bore needle. The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control. Through-the-Needle Technique: Perineural catheters are inserted through a straight hollow-bore needle	Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve. The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control. Suture-Method Technique: Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve
Measure Participants	35	35
Count of Participants [Participants]	3 8.6%	0 0%

Adverse Events

Time Frame	1 year
Arm/Group Title	Through-the-Needle Technique		Suture-Catheter
Arm/Group Description	19 Gauge Perineural catheter inserted via a 17 Gauge Touhy Neede		19 Gauge Perineural catheter via 19 G Suture needle
All Cause Mortality
	Through-the-Needle Technique		Suture-Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)
Serious Adverse Events
	Through-the-Needle Technique		Suture-Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		1/35 (2.9%)
Vascular disorders
Deep vein thrombosis	0/35 (0%)		1/35 (2.9%)	1
Other (Not Including Serious) Adverse Events
	Through-the-Needle Technique		Suture-Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)

Limitations/Caveats

[Not Specified]

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.