ClinicalTrials.gg
CompletedNCT00620828Updated Jun 3, 2015Results posted

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

A Phase 4 interventional study of Placebo saline injection and Ropivicaine 0.5% in Osteoarthritis, sponsored by Duke University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-06-03.

Sponsored by Duke University · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
67
Allocation
Randomized
Sex
All
01

Study 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. 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.

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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.

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Conditions studied

  • Osteoarthritis

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03

In context

Osteoarthritis

4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 67 is close to the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.

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Lead sponsor

Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
67 participants (actual)

Study arms

  • Placebo comparator
    Block Negative

    Subjects receive intra-op saline injection per protocol

    Other: Placebo saline injection

  • Experimental
    Block Positive

    Subjects receive intra-op Ropivicaine 0.5% injection per protocol

    Drug: Ropivicaine 0.5%

Interventions

  • OtherPlacebo saline injection

    20 cc of sterile, injectable saline

  • Ropivicaine

    Also known as: Hospiria

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What researchers measure

Primary outcomes

  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).

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

Secondary outcomes

  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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 4 hours, 8 hours, 12 hours and 24 hours post-op

07

Results

Posted May 3, 2013

Participant flow

12 of the 79 subjects enrolled were screening failures, thus total number of subjects completing the study = 67. One patient had staged bilateral TKA so there are 66 total patients, but 67 injections given.

Participant flow — Overall Study
MilestoneControl GroupBlock Group
Started3235
Number of subjects enrolled = 673235
Completed3235
Not completed00

Outcome measures

PrimaryNumeric 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).

Time frame:
Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection
Reported as:
Mean · units on a scale
Numeric Pain Score
units on a scaleBlock GroupControl Group
PACU0.67 ± 1.41.6 ± 2.8
4 hours2.5 ± 2.73.6 ± 2.8
8 hours3.8 ± 2.64.9 ± 2.8
12 hours3.2 ± 1.93.9 ± 2.6
24 hours3.9 ± 2.74.9 ± 2.6
Statistical analysis
  • Block Group vs Control Group · t-test, 2 sided · p = <0.05
SecondaryTotal 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.

Time frame:
4 hours to 24 hours post-op
Reported as:
Mean · micrograms
Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption
microgramsBlock GroupControl Group
4 hours22.4 ± 38.143.7 ± 71.9
8 hours95.6 ± 103.3126.6 ± 106.4
12 hours173.4 ± 175.4205.6 ± 177.5
24 hours418.5 ± 424.4292.2 ± 402.1
Statistical analysis
  • Block Group vs Control Group · ANOVA · p = .05
SecondaryPostoperative Day 1 Physical Therapy Outcome - Ambulation Distance

Ambulation distance walked by participants 24-hours post-operatively

Time frame:
24 hours post-op
Reported as:
Median · Feet
Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance
FeetBlock GroupControl Group
Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance38.4 ± 45.026.4 ± 27.7
Statistical analysis
  • Block Group vs Control Group · t-test, 1 sided · p = .05
SecondaryPostoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion

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

Time frame:
24 hours post-op
Reported as:
Mean · degrees
Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion
degreesBlock GroupControl Group
Knee extension7.8 ± 4.57.0 ± 4.8
Knee flexion71.5 ± 13.969.6 ± 14.1
Statistical analysis
  • Block Group vs Control Group · t-test, 1 sided · p = .05
SecondaryPostoperative Day 1 Physical Therapy Outcome - Straight Leg Raise

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

Time frame:
4 hours, 8 hours, 12 hours and 24 hours post-op
Reported as:
Number · participants
Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise
participantsBlock GroupControl Group
SLR 4 hrs45
SLR 8 hrs135
SLR 12 hrs125
SLR 24 hrs136
Statistical analysis
  • Block Group vs Control Group · Chi-squared · p = .05

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group—0/32 (0%)0/32 (0%)
Block Group—0/35 (0%)0/35 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Control GroupBlock GroupTotal
<=18 years000
Between 18 and 65 years6814
>=65 years262753
Age, Continuous
Age, Continuous(years)Control GroupBlock GroupTotal
Mean65.4 ± 266.9 ± 266.1 ± 2
Sex: Female, Male
Sex: Female, Male(Participants)Control GroupBlock GroupTotal
Female242044
Male81523
Region of Enrollment
Region of Enrollment(participants)Control GroupBlock GroupTotal
United States323567
Lean Body Weight
Lean Body Weight(kg)Control GroupBlock GroupTotal
Mean59.9 ± 12.462.9 ± 11.161.4 ± 11.75
08

Study locations

1 site
  • Duke University Adult Reconstructive Surgery
    Durham, North Carolina 27710, United States
09

References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2007, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.

Results were first posted in May 2013, 4 years 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2008
First posted
Feb 22, 2008
Start
May 2007
Primary completionActual
Jun 2008
CompletionActual
Jun 2008
Results first posted
May 3, 2013
Last update
Jun 3, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00620828
Lead sponsor
Duke University
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Feb 22, 2008
Start date
May 2007
Primary completion
Jun 2008
Completion
Jun 2008
Results posted
May 3, 2013
Last update
Jun 3, 2015

Study contacts

Michael P Bolognesi, M.D.
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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