Effects of Catheter Location on Postoperative Analgesia for Continuous Adductor Canal and Popliteal-Sciatic Nerve Blocks

NCT02523235 | Completed Phase 4 Results

• 1 other identifier: Prox-Distal Catheter Insertion
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, continuous adductor canal and popliteal-sciatic nerve blocks are used commonly for lower extremity post-operative pain control, specifically for total knee arthroplasty and foot/ankle surgery, respectively. A perineural catheter used to infuse local anesthetic for postoperative analgesia may be placed at various locations along the target nerves. Investigations of single-injection peripheral nerve blocks suggest that the onset of the block might be faster with one location over the other; but, the success rates are equivalent. However, remaining unknown is whether there is an optimal location to place a perineural catheter as part of a continuous peripheral nerve block.

Conditions

Post-surgical Pain; Total Knee Arthroplasty; Foot/Ankle Surgery; Catheterization for Postop Analgesia

Keywords

moderate pain; severe pain; surgery; postop analgesia; TKA; adductor catheter; poplital catheter; foot/ankle surgery

Outcome Measures

Primary Outcomes (1)

• Pain (Average): Numeric Rating Scale for Pain

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

  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)

Secondary Outcomes (7)

• Pain (Worst) :Numeric Rating Scale for Pain

  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)

• Analgesic Use: IV Morphine Equivalents

  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

• Ambulation: Distance in Meters

  Average for morning and afternoon following surgery

• Pain During Afternoon Physical Therapy Session

  Average during physical therapy in the afternoon following surgery

• Number of Participants That Had Fluid Leakage Reported at Catheter Site.

  From surgery through the day after surgery

Study Arms (2)

proximal catheter insertion

ACTIVE COMPARATOR

Adductor canal catheters: Inserted as described by Jæger et al., 2013: "…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. This level will be marked on the skin. 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.

Drug: ropivacaine 0.2%

distal catheter insertion

EXPERIMENTAL

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."

Drug: ropivacaine 0.2%

Interventions

ropivacaine 0.2% DRUG

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; proximal catheter insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing surgery with an adductor canal or popliteal-sciatic perineural catheter for postoperative analgesia following primary tri-compartment knee arthroplasty or foot/ankle surgery;
• anticipated to have at least moderate pain following surgery \[NRS\>3\]; and,
• age 18 years or older.

You may not qualify if:

• pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year);
• inability to communicate with the investigators and hospital staff;
• clinical neuropathy in the surgical extremity;
• chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone);
• BMI \> 40 kg/m2;
• allergy to study medications (lidocaine, ropivicaine);
• known renal insufficiency; or,
• incarceration.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University California San Diego

San Diego, California, 92103-8770, United States

Location

Related Publications (1)

• Sztain JF, Khatibi B, Monahan AM, Said ET, Abramson WB, Gabriel RA, Finneran JJ 4th, Bellars RH, Nguyen PL, Ball ST, Gonzales FB, Ahmed SS, Donohue MC, Padwal JA, Ilfeld BM. Proximal Versus Distal Continuous Adductor Canal Blocks: Does Varying Perineural Catheter Location Influence Analgesia? A Randomized, Subject-Masked, Controlled Clinical Trial. Anesth Analg. 2018 Jul;127(1):240-246. doi: 10.1213/ANE.0000000000003422.

  PMID: 29750695 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Brian Ilfeld, MD, MS
• Organization: University California San Diego

bilfeld@ucsd.edu

858-822-0776

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Study Record Dates

• First Submitted: August 9, 2015
• First Posted: August 14, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 3, 2019
• Results First Posted: September 3, 2019

Record last verified: 2019-08

Locations

US (1)