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

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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

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Hip Regional Anesthesia Other Acute Postoperative Pain Total Hip Arthroplasty Peripheral Nerve Block Lumbar Plexus Nerve Block Parasacaral (Sciatic) Nerve Block Procedure: Continuous Lumbar Plexus Block Procedure: Parasacral Nerve Block Drug: Ropivacine 0.2% Drug: Bupivacaine 0.0625% Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2014
Actual Primary Completion Date : June 17, 2014
Actual Study Completion Date : June 17, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
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.

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.

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.

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.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively [ Time Frame: 48 hours after the start of the surgery ]
  2. 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).

  3. Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively [ Time Frame: 48 hours after the start of the surgery ]
  4. Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively [ Time Frame: 48 hours after the start of the surgery ]
  5. 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)


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161484


Locations
United States, Pennsylvania
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Rita Merman
Investigators
Principal Investigator: Rita Merman, MD UPMC Presbyterian Shadyside
Study Chair: Jacques E. Chelly, MD, PhD, MBA UPMC Presbyterian Shadyside

Publications:
Responsible Party: Rita Merman, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02161484     History of Changes
Other Study ID Numbers: PRO13030184
First Posted: June 11, 2014    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by Rita Merman, University of Pittsburgh:
Peripheral Nerve Block
Total Hip Replacement

Additional relevant MeSH terms:
Osteoarthritis
Pain, Postoperative
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents