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

Primary Purpose

Osteoarthritis of Hip, Regional Anesthesia, Other Acute Postoperative Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Lumbar Plexus Block
Parasacral Nerve Block
Ropivacine 0.2%
Bupivacaine 0.0625%
Sponsored by
Rita Merman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Hip focused on measuring Peripheral Nerve Block, Total Hip Replacement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Presbyterian Shadyside

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar Plexus Nerve Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric Rating Scale (NRS) Pain Assessment
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
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
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

Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively
Amount of Oxycodone for the First 48 h Post Operatively
Including number of dose and mg).
Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively
Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively
Total Amount of Local Anesthetic in 48 Hours Post Operatively
Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)

Full Information

First Posted
June 2, 2014
Last Updated
March 2, 2018
Sponsor
Rita Merman
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1. Study Identification

Unique Protocol Identification Number
NCT02161484
Brief Title
Continuous Lumbar Plexus Block With and Without Parasacral Block in Patients Undergoing Total Hip Replacement
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 Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
The computer is crushed and all data is lost (IT was not able to recover it. Last data was collected 6.17.14)
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 17, 2014 (Actual)
Study Completion Date
June 17, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rita Merman

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Hip, Regional Anesthesia, Other Acute Postoperative Pain, Total Hip Arthroplasty, Peripheral Nerve Block, Lumbar Plexus Nerve Block, Parasacaral (Sciatic) Nerve Block
Keywords
Peripheral Nerve Block, Total Hip Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Lumbar Plexus Block with Parasacral Nerve Block
Arm Type
Experimental
Arm Description
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.
Arm Title
Lumbar Plexus Nerve Block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Continuous Lumbar Plexus Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Parasacral Nerve Block
Other Intervention Name(s)
Sciatic Nerve Block
Intervention Description
A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.
Intervention Type
Drug
Intervention Name(s)
Ropivacine 0.2%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.0625%
Intervention Description
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 Measure Information:
Title
Numeric Rating Scale (NRS) Pain Assessment
Description
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.
Time Frame
6 hours after the start of surgery
Title
Numeric Rating Scale (NRS) Pain Assessment
Description
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.
Time Frame
24 hours after the start of surgery
Title
Numeric Rating Scale (NRS) Pain Assessment
Description
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.
Time Frame
48 hours after the start of surgery
Secondary Outcome Measure Information:
Title
Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively
Time Frame
48 hours after the start of the surgery
Title
Amount of Oxycodone for the First 48 h Post Operatively
Description
Including number of dose and mg).
Time Frame
48 hours after the start of the surgery
Title
Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively
Time Frame
48 hours after the start of the surgery
Title
Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively
Time Frame
48 hours after the start of the surgery
Title
Total Amount of Local Anesthetic in 48 Hours Post Operatively
Description
Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)
Time Frame
48 hours after the start of the surgery
Other Pre-specified Outcome Measures:
Title
Incidence of Complications (e.g. Frequency of Foot-drop).
Description
Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, "Foot Drop", allergic reaction will be recorded
Time Frame
48 hours after the start of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has signed and dated an Informed Consent Form. Subject is classified as a ASA (American Society of Anesthesiologists) status I-III Subject is age 18- 75 years old. Subject is having primary total hip arthroplasty No contraindication to peripheral nerve catheter ( local infection or hypocoagulable state) Patient willing to receive spinal anesthesia as operative anesthesia No known drug allergies to study medications Patients not expected to receive therapeutic anticoagulation in the postoperative period. Exclusion Criteria: Subject inability to provide adequate informed consent. Age younger than 18 years or older than 75 years Any contraindication to the placement of lumbar plexus catheter, including local infection, hypocoagulable state. ASA (American Society of Anesthesiologists) physical status of IV or greater Any chronic painful conditions Preoperative opioid use Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Merman, MD
Organizational Affiliation
UPMC Presbyterian Shadyside
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques E. Chelly, MD, PhD, MBA
Organizational Affiliation
UPMC Presbyterian Shadyside
Official's Role
Study Chair
Facility Information:
Facility Name
UPMC Presbyterian Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19448235
Citation
Ben-Ari AY, Joshi R, Uskova A, Chelly JE. Ultrasound localization of the sacral plexus using a parasacral approach. Anesth Analg. 2009 Jun;108(6):1977-80. doi: 10.1213/ane.0b013e3181a04d8e.
Results Reference
background
PubMed Identifier
12419722
Citation
Ho AM, Karmakar MK. Combined paravertebral lumbar plexus and parasacral sciatic nerve block for reduction of hip fracture in a patient with severe aortic stenosis. Can J Anaesth. 2002 Nov;49(9):946-50. doi: 10.1007/BF03016880.
Results Reference
background
PubMed Identifier
9168212
Citation
Morris GF, Lang SA, Dust WN, Van der Wal M. The parasacral sciatic nerve block. Reg Anesth. 1997 May-Jun;22(3):223-8. doi: 10.1016/s1098-7339(06)80005-2.
Results Reference
background
PubMed Identifier
17513661
Citation
Wiegel M, Gottschaldt U, Hennebach R, Hirschberg T, Reske A. Complications and adverse effects associated with continuous peripheral nerve blocks in orthopedic patients. Anesth Analg. 2007 Jun;104(6):1578-82, table of contents. doi: 10.1213/01.ane.0000261260.69083.f3.
Results Reference
background
PubMed Identifier
21467563
Citation
Ilfeld BM, Mariano ER, Madison SJ, Loland VJ, Sandhu NS, Suresh PJ, Bishop ML, Kim TE, Donohue MC, Kulidjian AA, Ball ST. Continuous femoral versus posterior lumbar plexus nerve blocks for analgesia after hip arthroplasty: a randomized, controlled study. Anesth Analg. 2011 Oct;113(4):897-903. doi: 10.1213/ANE.0b013e318212495b. Epub 2011 Apr 5.
Results Reference
background
PubMed Identifier
19122076
Citation
Marino J, Russo J, Kenny M, Herenstein R, Livote E, Chelly JE. Continuous lumbar plexus block for postoperative pain control after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2009 Jan;91(1):29-37. doi: 10.2106/JBJS.H.00079.
Results Reference
background

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

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