Trial Outcomes & Findings for Effects of Catheter Location on Postoperative Analgesia for Continuous Adductor Canal and Popliteal-Sciatic Nerve Blocks (NCT NCT02523235)

Results Overview

Numeric Rating Scale for Pain (0-10; 0=no pain and 10=worst imaginable pain)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

117 participants

Primary outcome timeframe

Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal)

Results posted on

2019-09-03

Participant Flow

3 subjects were enrolled (signed ICF), but were not included in the results: (1) two found to have inferior visualization of the distal location and therefore excluded before randomization per protocol and (2) one subject randomized to the proximal location experienced an intraoperative medical complication unrelated to the study and was withdrawn

Participant milestones

Participant milestones
Measure	Proximal Catheter Insertion Adductor canal catheters: at the medial part of the thigh, halfway between the superior anterior iliac spine and the \[superior border of the\] patella. Popliteal catheters: the bifurcation of the sciatic nerve was identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (addu	Distal Catheter Insertion Adductor canal catheters: Inserted as described by Manickam et al. 2009 Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected." ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Overall Study STARTED	56	58
Overall Study COMPLETED	56	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proximal Catheter Insertion n=56 Participants Adductor canal catheters: we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the \[superior border of the\] patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. The needle will be inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread. ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30	Distal Catheter Insertion n=58 Participants Adductor canal catheters: Inserted as described by Manickam et al. 2009 Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected." ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout	Total n=114 Participants Total of all reporting groups
Age, Continuous Age (years)	69 years STANDARD_DEVIATION 10 • n=56 Participants	69 years STANDARD_DEVIATION 9 • n=58 Participants	69 years STANDARD_DEVIATION 10 • n=114 Participants
Sex: Female, Male Female	25 Participants n=56 Participants	35 Participants n=58 Participants	60 Participants n=114 Participants
Sex: Female, Male Male	31 Participants n=56 Participants	23 Participants n=58 Participants	54 Participants n=114 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal)

Population: Adductor canal subjects

Numeric Rating Scale for Pain (0-10; 0=no pain and 10=worst imaginable pain)

Outcome measures

Outcome measures
Measure	Proximal Catheter Insertion n=25 Participants we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout	Distal Catheter Insertion n=26 Participants Adductor canal catheters: Inserted as described by Manickam et al. 2009 Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected." ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Pain (Average): Numeric Rating Scale for Pain	0.5 score on a scale Interval 0.0 to 3.2	3.0 score on a scale Interval 2.0 to 5.4

SECONDARY outcome

Timeframe: Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal)

Population: Adductor canal subjects

Numeric Rating Scale for Pain (0-10; 0=no pain and 10=worst imaginable pain)

Outcome measures

Outcome measures
Measure	Proximal Catheter Insertion n=25 Participants we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout	Distal Catheter Insertion n=26 Participants Adductor canal catheters: Inserted as described by Manickam et al. 2009 Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected." ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Pain (Worst) :Numeric Rating Scale for Pain	4.0 score on a scale Interval 0.0 to 7.0	5.0 score on a scale Interval 3.6 to 7.5

SECONDARY outcome

Timeframe: Average for Intraoperative, in the recovery room, after the recovery room until 08:00 day after surgery, and 08:00-24:00 day after surgery

Population: adductor canal subjects, POD 1 8:00 am through 12 pm

IV morphine equivalents

Outcome measures

Outcome measures
Measure	Proximal Catheter Insertion n=24 Participants we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout	Distal Catheter Insertion n=26 Participants Adductor canal catheters: Inserted as described by Manickam et al. 2009 Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected." ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Analgesic Use: IV Morphine Equivalents	6.7 mg Interval 3.3 to 10.4	6.7 mg Interval 3.3 to 15.0

SECONDARY outcome

Timeframe: Average for morning and afternoon following surgery

Population: adductor canal afternoon after surgery

distance in meters

Outcome measures

Outcome measures
Measure	Proximal Catheter Insertion n=24 Participants we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout	Distal Catheter Insertion n=26 Participants Adductor canal catheters: Inserted as described by Manickam et al. 2009 Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected." ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Ambulation: Distance in Meters	150 meters Interval 92.0 to 200.0	170 meters Interval 129.0 to 200.0

SECONDARY outcome

Timeframe: Average during physical therapy in the afternoon following surgery

Population: adductor canal afternoon therapy

Pain during afternoon physical therapy session as measured with the Numeric Rating Scale (0-10; 0=no pain and 10=worst imaginable pain)

Outcome measures

Outcome measures
Measure	Proximal Catheter Insertion n=24 Participants we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout	Distal Catheter Insertion n=26 Participants Adductor canal catheters: Inserted as described by Manickam et al. 2009 Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected." ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Pain During Afternoon Physical Therapy Session	3.0 score on a scale Interval 0.0 to 5.0	3.0 score on a scale Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: From surgery through the day after surgery

Population: adductor canal subjects

If subjects detected leakage at the catheter site, the response was recorded as "yes"; and, if subjects did not detect leakage at the catheter site, the response was recorded as "no".

Outcome measures

Outcome measures
Measure	Proximal Catheter Insertion n=24 Participants we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout	Distal Catheter Insertion n=26 Participants Adductor canal catheters: Inserted as described by Manickam et al. 2009 Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected." ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Number of Participants That Had Fluid Leakage Reported at Catheter Site.	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Average for the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal only)

Population: popliteal-sciatic subjects

0-10 scale, 0=no numbness and 10=completely insensate

Outcome measures

Outcome measures
Measure	Proximal Catheter Insertion n=31 Participants we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout	Distal Catheter Insertion n=32 Participants Adductor canal catheters: Inserted as described by Manickam et al. 2009 Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected." ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Toe/Foot Numbness (Insensate) :0-10 Scale	7.0 score on a scale Interval 4.0 to 8.5	7.0 score on a scale Interval 5.0 to 9.2

SECONDARY outcome

Timeframe: The day following surgery recorded during mid-day rounds

Population: adductor volume bolus doses volume (excluding basal infusion)

mL

Outcome measures

Outcome measures
Measure	Proximal Catheter Insertion n=24 Participants we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout	Distal Catheter Insertion n=26 Participants Adductor canal catheters: Inserted as described by Manickam et al. 2009 Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected." ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Total Local Anesthetic Infused (Adductor Only) : mL	32 mL Interval 16.0 to 60.0	40 mL Interval 20.0 to 68.0

Adverse Events

Proximal Catheter Insertion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Distal Catheter Insertion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian Ilfeld, MD, MS

University California San Diego

Phone: 858-822-0776

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place