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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions: Osteoarthritis of Hip
Regional Anesthesia
Other Acute Postoperative Pain
Total Hip Arthroplasty
Peripheral Nerve Block
Lumbar Plexus Nerve Block
Parasacaral (Sciatic) Nerve Block
Interventions: Procedure: Continuous Lumbar Plexus Block
Procedure: Parasacral Nerve Block
Drug: Ropivacine 0.2%
Drug: Bupivacaine 0.0625%

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Continuous Lumbar Plexus Block With Parasacral Nerve Block

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.

Lumbar Plexus Nerve Block

Arm: 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.


Participant Flow:   Overall Study
    Continuous Lumbar Plexus Block With Parasacral Nerve Block   Lumbar Plexus Nerve Block
STARTED   5   5 
COMPLETED   1   2 
NOT COMPLETED   4   3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Continuous Lumbar Plexus Block With Parasacral Nerve Block

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.

Lumbar Plexus Nerve Block

Arm: 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.

Total Total of all reporting groups

Baseline Measures
   Continuous Lumbar Plexus Block With Parasacral Nerve Block   Lumbar Plexus Nerve Block   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.8  (2.86)   58.6  (7.67)   57.7  (5.54) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  40.0%      4  80.0%      6  60.0% 
Male      3  60.0%      1  20.0%      4  40.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      5 100.0%      5 100.0%      10 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      5 100.0%      5 100.0%      10 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   5   5   10 


  Outcome Measures

1.  Primary:   Numeric Rating Scale (NRS) Pain Assessment   [ Time Frame: 6 hours after the start of surgery ]

2.  Primary:   Numeric Rating Scale (NRS) Pain Assessment   [ Time Frame: 24 hours after the start of surgery ]

3.  Primary:   Numeric Rating Scale (NRS) Pain Assessment   [ Time Frame: 48 hours after the start of surgery ]

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

5.  Secondary:   Amount of Oxycodone for the First 48 h Post Operatively   [ Time Frame: 48 hours after the start of the surgery ]

6.  Secondary:   Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively   [ Time Frame: 48 hours after the start of the surgery ]

7.  Secondary:   Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively   [ Time Frame: 48 hours after the start of the surgery ]

8.  Secondary:   Total Amount of Local Anesthetic in 48 Hours Post Operatively   [ Time Frame: 48 hours after the start of the surgery ]

9.  Other Pre-specified:   Incidence of Complications (e.g. Frequency of Foot-drop).   [ Time Frame: 48 hours after the start of the surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Rita Merman, P.I.
Organization: University of Pittsburgh
phone: 41256322137
e-mail: MermanRB@upmc.edu


Publications:

Responsible Party: Rita Merman, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02161484     History of Changes
Other Study ID Numbers: PRO13030184
First Submitted: June 2, 2014
First Posted: June 11, 2014
Results First Submitted: January 31, 2018
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018