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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoarthritis of Hip, Regional Anesthesia, Other Acute Postoperative Pain, Total Hip Arthroplasty, Peripheral Nerve Block, Lumbar Plexus Nerve Block, Parasacaral (Sciatic) Nerve Block

Intervention / Treatment
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* Procedure: Continuous Lumbar Plexus Block
* Procedure: Parasacral Nerve Block
* Drug: Ropivacine 0.2%
* Drug: Bupivacaine 0.0625%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block<br>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<br>* 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.<br>Procedure: Parasacral Nerve Block<br>* A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.<br>* Other names: Sciatic Nerve Block;Drug: Ropivacine 0.2%<br>* 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.<br>Drug: Bupivacaine 0.0625%<br>* 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.<br>|
| Active Comparator: Lumbar Plexus Nerve Block<br>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<br>* 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.<br>Drug: Ropivacine 0.2%<br>* 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.<br>Drug: Bupivacaine 0.0625%<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 hours after the start of surgery | 
| 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. | 24 hours after the start of surgery | 
| 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. | 48 hours after the start of surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Nerve Block, Total Hip Replacement