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OsteoarthritisPhase 4NCT00620828

The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty

A Phase 4 study testing Ropivicaine 0.5% in people with Osteoarthritis, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Osteoarthritis
What is being tested?
Ropivicaine 0.5%
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
1 siteUnited States
Study dates
May 2007to Jun 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • The subject is scheduled to undergo elective total knee replacement at Duke University Hospital.
  • The subject has signed the written consent form.

Who cannot join

  • Known allergy to ropivacaine or hydromorphone.
  • Known history of narcotic abuse or alcohol abuse.
  • Known history of chronic pain.
  • Known diagnosis of peripheral neuropathy or complex regional pain syndrome.
  • Significant impediment to physical therapy participation.
  • The surgery is a revision case.
  • Patient is undergoing bilateral Total Knee Replacement.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University Adult Reconstructive Surgery

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Trial

The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.

Read the detailed description

Research Summary

Purpose of Study This prospective, randomized, blinded controlled trial will be conducted to evaluate post-operative pain control and physical therapy outcomes in primary total knee arthroplasty (TKA) with the use of spinal analgesia and intra-operative posterior capsular injections of ropivicaine 0.5% in conjunction with a continuous femoral nerve catheter.

We believe the results of this study will show an improvement in pain control and physical therapy outcomes compared to traditional methods of analgesia in post-op total knee arthroplasty. To the best of our knowledge, there are no studies in the literature using this combination of femoral nerve analgesia and posterior capsular injection.

Certainly regional anesthesia methods such as femoral nerve blocks used alone or in conjunction with sciatic nerve blocks have improved patient pain outcome measures in total knee arthroplasty. Several studies have shown a beneficial effect of intra-articular analgesia after capsular closure. We believe our study design will combine the beneficial effects of the aforementioned methods, and ultimately improve patient pain, therapy effort, and safety through less narcotic use.

Our goal is to share these results in a peer-reviewed journal, and at national orthopaedic or anesthesia meetings. The data collected will ideally improve care and safety in the post-operative total knee arthroplasty patient.

Background and Significance Post-operative pain control in total knee arthroplasty is an area of great study in the orthopaedic surgery and anesthesia literature. The use of spinal/epidural alone or in combination with regional anesthesia is well studied in the recent literature. These techniques have significantly improved patient pain management, physical/occupational therapy outcomes, and shortened time to discharge.

Additionally, intra-articular injection of local anesthetic after capsular closure has been studied recently. Several studies have demonstrated a beneficial effect of intra-articular local anesthetic on pain outcome measures (6, 8, 9, 10, 15). Although other studies have reported more equivocal results. The impact of capsular analgesia has on post-operative pain is intriguing. Decreased afferent pain perception by the capsular nerves from local anesthetic may improve outcomes, especially in sensory distributions where regional anesthesia is inadequate or not performed.

Much study has centered on regional anesthesia, specifically the use of single shot or continuous femoral nerve blockade (4, 5, 11, 14, 16). Such studies have demonstrated a statistically significant decrease in total narcotic use, sedation scores, and visual analog pain scores. Femoral nerve blockade is now an accepted method of post-op pain control in the total knee arthroplasty patient.

Further investigation has centered on the addition of sciatic nerve blockade to femoral nerve block (1-3, 7, 12, 13). Several studies demonstrate a further improvement in pain outcomes compared to isolated femoral nerve anesthesia. Sciatic nerve blocks can slow physical therapy efforts secondary to a dense motor blockade. Equivocal results have been reported in other studies due to this motor block, however, the sensory component appears to provide improved pain outcome measures.

Femoral nerve blockade is a well-accepted modality for analgesia in total knee arthroplasty. However, femoral nerve block alone does not provide adequate anesthesia to the posterior aspect of the knee. We believe that intra-operative injection of ropivicaine 0.5% into the posterior capsule will provide analgesia analogous to the sensory component of a sciatic nerve block, while eliminating the limiting effects of the motor blockade. The combination of femoral nerve block and intra-operative posterior capsular injection will ideally yield improved pain management and physical therapy efforts above a baseline femoral nerve block.

Design and procedures This is a prospective double-blinded, randomized trial consisting of two study groups: posterior capsular saline injection (control), and the experimental posterior capsular ropivicaine 0.5% injection group. All patients will receive spinal anesthesia and a continuous femoral nerve block. Each group will include 45 patients (n = 90 patients).

All patients will have an elective primary total knee arthroplasty performed. No revision or bilateral cases will be included. Exclusion criteria will include patients with a known allergy to ropivicaine or fentanyl, a known history of narcotic abuse or chronic pain, a known diagnosis of peripheral neuropathy or complex regional pain syndrome, or a significant impediment to physical therapy participation.

Following the informed consent process, patients will receive a continuous femoral nerve block via catheter placed by experienced regional anesthesiologists at our institution. Each patient will also receive spinal anesthesia for intra-operative pain control. A standard midline skin incision with medial para-patellar arthrotomy will be performed followed by implantation of either a Next Gen (Zimmer/Warsaw, IN), or Natural Knee II (Zimmer, Warsaw, IN), or Posterior Femoral Component (PFC) Sigma (DePuy, Warsaw, IN) system. Prior to surgery, patients will be randomized to the saline or ropivicaine groups. Both groups will receive their respective injection prior to implantation of the components.

The posterior capsule of the knee will be divided in to four quadrants, each receiving a saline or ropivicaine injection per randomization. Safety measures will include standard pre-injection aspiration to check for vascular blush and intra-operative Doppler ultrasound to identify vascular structures in the posterior knee. Additionally, the anesthesiologist will not be blinded, as he/she will be responsible for assuring the appropriate medication is used, and will be closely monitoring for cardiac arrhythmias in the unlikely event that an intravascular injection occurs. Post-operatively, a standard bulky dressing will be applied. All patients will be weight bearing as tolerated post-operative day 1. A fentanyl PCA will be initiated in the PACU, and will be continued until post-operative day 2. Dosing will be calculated based on lean body mass. Continuous femoral nerve blockade will continue until post-operative day 2 as well.

Outcomes will include total PCA narcotic use, visual analog pain scale with a diagram to localize pain, and Ramsey sedation scores. This data will be collected at the following intervals: in the PACU, 4, 8, 12, and 24 hours post-operatively. We will also measure post-operative day 1 knee range of motion, total ambulation distance, and time to straight leg raise. A standard, Institutional Review Board (IRB) approved, data collection sheet will be utilized.

We hypothesize that total post-operative narcotic use, visual analog pain scores, and Ramsey sedation scores will be significantly lower in the study group (posterior capsular ropivicaine 0.5% injection). Additionally, we anticipate the knee range of motion, total ambulation distance, and time to straight leg raise to be significantly improved as well.

Conditions
Osteoarthritis
Being tested
Placebo saline injection, Ropivicaine 0.5%
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo saline injectionOther

    20 cc of sterile, injectable saline

  • Ropivicaine 0.5%Drug

    Also called Hospiria

    Ropivicaine

Study groups in NCT00620828
Study groupRoleWhat they receive
Block NegativePlacebo comparatorSubjects receive intra-op saline injection per protocol
Receives: Other: Placebo saline injection
Block PositiveExperimentalSubjects receive intra-op Ropivicaine 0.5% injection per protocol
Receives: Drug: Ropivicaine 0.5%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Pain Score

    Participants were asked to rate their pain on a scale of 0 to 10 at all time intervals up to 24 hours post-injection. Scores were organized into the following categories: 3 or less (mild pain), 4 to 6 (moderate pain), 7 or higher (severe pain).

    Measured: Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection

Secondary outcomes (4)
  1. Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption

    The PCA total dose at the 4-hour, 8-hour, 12-hour and 24-hour post-operative time points.

    Measured: 4 hours to 24 hours post-op

  2. Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance

    Ambulation distance walked by participants 24-hours post-operatively

    Measured: 24 hours post-op

  3. Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion

    Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort

    Measured: 24 hours post-op

  4. Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise

    Straight Leg Raise (SLR): number of people that can perform a SLR at designated intervals

    Measured: 4 hours, 8 hours, 12 hours and 24 hours post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00620828
Sponsor's protocol ID
Pro00000233
Other IDs
SPS# 139715
Status last verified
Mar 2013
First submitted
12 Feb 2008
Last updated
3 Jun 2015
Data monitoring committee
No

Publications

  • Ben-David B, Schmalenberger K, Chelly JE. Analgesia after total knee arthroplasty: is continuous sciatic blockade needed in addition to continuous femoral blockade? Anesth Analg. 2004 Mar;98(3):747-9, table of contents. doi: 10.1213/01.ane.0000096186.89230.56.

    PubMed 14980931
  • Cook P, Stevens J, Gaudron C. Comparing the effects of femoral nerve block versus femoral and sciatic nerve block on pain and opiate consumption after total knee arthroplasty. J Arthroplasty. 2003 Aug;18(5):583-6. doi: 10.1016/s0883-5403(03)00198-0.

    PubMed 12934209
  • Davies AF, Segar EP, Murdoch J, Wright DE, Wilson IH. Epidural infusion or combined femoral and sciatic nerve blocks as perioperative analgesia for knee arthroplasty. Br J Anaesth. 2004 Sep;93(3):368-74. doi: 10.1093/bja/aeh224. Epub 2004 Jul 9.

    PubMed 15247111
  • Edwards ND, Wright EM. Continuous low-dose 3-in-1 nerve blockade for postoperative pain relief after total knee replacement. Anesth Analg. 1992 Aug;75(2):265-7. doi: 10.1213/00000539-199208000-00020.

    PubMed 1632541
  • Hirst GC, Lang SA, Dust WN, Cassidy JD, Yip RW. Femoral nerve block. Single injection versus continuous infusion for total knee arthroplasty. Reg Anesth. 1996 Jul-Aug;21(4):292-7.

    PubMed 8837185
  • Klasen JA, Opitz SA, Melzer C, Thiel A, Hempelmann G. Intraarticular, epidural, and intravenous analgesia after total knee arthroplasty. Acta Anaesthesiol Scand. 1999 Nov;43(10):1021-6. doi: 10.1034/j.1399-6576.1999.431009.x.

    PubMed 10593465
  • Lau HP, Yip KM, Jiang CC. Regional nerve block for total knee arthroplasty. J Formos Med Assoc. 1998 Jun;97(6):428-30.

    PubMed 9650474
  • Lombardi AV Jr, Berend KR, Mallory TH, Dodds KL, Adams JB. Soft tissue and intra-articular injection of bupivacaine, epinephrine, and morphine has a beneficial effect after total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):125-30. doi: 10.1097/01.blo.0000147701.24029.cc.

    PubMed 15534532
  • Mauerhan DR, Campbell M, Miller JS, Mokris JG, Gregory A, Kiebzak GM. Intra-articular morphine and/or bupivacaine in the management of pain after total knee arthroplasty. J Arthroplasty. 1997 Aug;12(5):546-52. doi: 10.1016/s0883-5403(97)90178-9.

    PubMed 9268795
  • Nechleba J, Rogers V, Cortina G, Cooney T. Continuous intra-articular infusion of bupivacaine for postoperative pain following total knee arthroplasty. J Knee Surg. 2005 Jul;18(3):197-202. doi: 10.1055/s-0030-1248181.

    PubMed 16152868
  • Niskanen RO, Strandberg N. Bedside femoral block performed on the first postoperative day after unilateral total knee arthroplasty: a randomized study of 49 patients. J Knee Surg. 2005 Jul;18(3):192-6. doi: 10.1055/s-0030-1248180.

    PubMed 16152867
  • Pham Dang C, Gautheron E, Guilley J, Fernandez M, Waast D, Volteau C, Nguyen JM, Pinaud M. The value of adding sciatic block to continuous femoral block for analgesia after total knee replacement. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):128-33. doi: 10.1016/j.rapm.2004.11.009.

    PubMed 15765454
  • Szczukowski MJ Jr, Hines JA, Snell JA, Sisca TS. Femoral nerve block for total knee arthroplasty patients: a method to control postoperative pain. J Arthroplasty. 2004 Sep;19(6):720-5. doi: 10.1016/j.arth.2004.02.043.

    PubMed 15343531
  • Tanaka N, Sakahashi H, Sato E, Hirose K, Ishii S. The efficacy of intra-articular analgesia after total knee arthroplasty in patients with rheumatoid arthritis and in patients with osteoarthritis. J Arthroplasty. 2001 Apr;16(3):306-11. doi: 10.1054/arth.2001.21496.

    PubMed 11307127
  • Wang H, Boctor B, Verner J. The effect of single-injection femoral nerve block on rehabilitation and length of hospital stay after total knee replacement. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):139-44. doi: 10.1053/rapm.2002.29253.

    PubMed 11915059

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivicaine 0.5% in people with Osteoarthritis, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Score (time frame: Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00620828, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.

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