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Continuous Lumbar Plexus Block With and Without Parasacral Block in Patients Undergoing Total Hip Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161484
Recruitment Status : Terminated (The computer is crushed and all data is lost (IT was not able to recover it. Last data was collected 6.17.14))
First Posted : June 11, 2014
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Rita Merman, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE June 2, 2014
First Posted Date  ICMJE June 11, 2014
Results First Submitted Date  ICMJE January 31, 2018
Results First Posted Date  ICMJE March 29, 2018
Last Update Posted Date March 29, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date June 17, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Numeric Rating Scale (NRS) Pain Assessment [ Time Frame: 6 hours after the start of surgery ]
    Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
  • Numeric Rating Scale (NRS) Pain Assessment [ Time Frame: 24 hours after the start of surgery ]
    Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
  • Numeric Rating Scale (NRS) Pain Assessment [ Time Frame: 48 hours after the start of surgery ]
    Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2014)
  • Numeric Rating Scale (NRS) Pain Assessment [ Time Frame: 6 hours after the start of surgery ]
    Postoperative pain assessments using a 11-point numerical rating (0-10) during physical therapy and at rest.
  • Numeric Rating Scale (NRS) Pain Assessment [ Time Frame: 24 hours after the start of surgery ]
    Postoperative pain assessments using a 11-point numerical rating (0-10) during physical therapy and at rest.
  • Numeric Rating Scale (NRS) Pain Assessment [ Time Frame: 48 hours after the start of surgery ]
    Postoperative pain assessments using a 11-point numerical rating (0-10) during physical therapy and at rest
Change History Complete list of historical versions of study NCT02161484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2014)
  • Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively [ Time Frame: 48 hours after the start of the surgery ]
  • Amount of Oxycodone for the First 48 h Post Operatively [ Time Frame: 48 hours after the start of the surgery ]
    Including number of dose and mg).
  • Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively [ Time Frame: 48 hours after the start of the surgery ]
  • Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively [ Time Frame: 48 hours after the start of the surgery ]
  • Total Amount of Local Anesthetic in 48 Hours Post Operatively [ Time Frame: 48 hours after the start of the surgery ]
    Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 9, 2014)
Incidence of Complications (e.g. Frequency of Foot-drop). [ Time Frame: 48 hours after the start of the surgery ]
Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, "Foot Drop", allergic reaction will be recorded
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Continuous Lumbar Plexus Block With and Without Parasacral Block in Patients Undergoing Total Hip Replacement
Official Title  ICMJE A Prospective, Randomized, Blinded, Controlled Study Evaluating the Efficacy of Continuous Lumbar Plexus Block With and Without Parasacral Block in Patients Undergoing Total Hip Replacement
Brief Summary The purpose of this research study is to evaluate the analgesic efficacy of adding a single shot parasacral (sciatic) nerve block to a continuous lumbar plexus block in patients undergoing total hip replacement.
Detailed Description This prospective study is intended to assess the efficacy of placing a parasacral (sciatic) nerve block in addition to a lumbar plexus block for postoperative analgesia following total hip arthroplasty. Although the placement of a lumbar plexus block alone has become accepted as the standard of care at UPMC for postoperative analgesia following total hip arthroplasty, the addition of a parasacral (sciatic) nerve block may provide the advantage of blocking the superior gluteal nerve and nerve to the quadratus femoris which both supply small articular sensory branches to the posterior hip capsule.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis of Hip
  • Regional Anesthesia
  • Other Acute Postoperative Pain
  • Total Hip Arthroplasty
  • Peripheral Nerve Block
  • Lumbar Plexus Nerve Block
  • Parasacaral (Sciatic) Nerve Block
Intervention  ICMJE
  • Procedure: Continuous Lumbar Plexus Block
    Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.
  • Procedure: Parasacral Nerve Block
    A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.
    Other Name: Sciatic Nerve Block
  • Drug: Ropivacine 0.2%
    Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm.
  • Drug: Bupivacaine 0.0625%
    In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.
Study Arms  ICMJE
  • Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

    Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

    A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

    Interventions:
    • Procedure: Continuous Lumbar Plexus Block
    • Procedure: Parasacral Nerve Block
    • Drug: Ropivacine 0.2%
    • Drug: Bupivacaine 0.0625%
  • Active Comparator: Lumbar Plexus Nerve Block

    Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

    No sham/placebo parasacral (sciatic) blocks will be performed in this group.

    Interventions:
    • Procedure: Continuous Lumbar Plexus Block
    • Drug: Ropivacine 0.2%
    • Drug: Bupivacaine 0.0625%
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 2, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2014)
50
Actual Study Completion Date  ICMJE June 17, 2014
Actual Primary Completion Date June 17, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has signed and dated an Informed Consent Form.
  2. Subject is classified as a ASA (American Society of Anesthesiologists) status I-III
  3. Subject is age 18- 75 years old.
  4. Subject is having primary total hip arthroplasty
  5. No contraindication to peripheral nerve catheter ( local infection or hypocoagulable state)
  6. Patient willing to receive spinal anesthesia as operative anesthesia
  7. No known drug allergies to study medications
  8. Patients not expected to receive therapeutic anticoagulation in the postoperative period.

Exclusion Criteria:

  1. Subject inability to provide adequate informed consent.
  2. Age younger than 18 years or older than 75 years
  3. Any contraindication to the placement of lumbar plexus catheter, including local infection, hypocoagulable state.
  4. ASA (American Society of Anesthesiologists) physical status of IV or greater
  5. Any chronic painful conditions
  6. Preoperative opioid use
  7. Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02161484
Other Study ID Numbers  ICMJE PRO13030184
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rita Merman, University of Pittsburgh
Study Sponsor  ICMJE Rita Merman
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rita Merman, MD UPMC Presbyterian Shadyside
Study Chair: Jacques E. Chelly, MD, PhD, MBA UPMC Presbyterian Shadyside
PRS Account University of Pittsburgh
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP