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

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

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.

Study Overview

• Status: Terminated
• Conditions: Total Hip Arthroplasty; Regional Anesthesia; Peripheral Nerve Block; Osteoarthritis of Hip; Other Acute Postoperative Pain; Lumbar Plexus Nerve Block; Parasacaral (Sciatic) Nerve Block
• Intervention / Treatment: Procedure: Continuous Lumbar Plexus Block; Procedure: Parasacral Nerve Block; Drug: Ropivacine 0.2%; Drug: Bupivacaine 0.0625%

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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Presbyterian Shadyside

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Complications (e.g. Frequency of Foot-drop).	Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, "Foot Drop", allergic reaction will be recorded	48 hours after the start of the surgery

Collaborators and Investigators

• Sponsor: Rita Merman
• Investigators: Principal Investigator: Rita Merman, MD, UPMC Presbyterian Shadyside; Study Chair: Jacques E. Chelly, MD, PhD, MBA, UPMC Presbyterian Shadyside

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): June 17, 2014
• Study Completion (ACTUAL): June 17, 2014

Study Registration Dates

• First Submitted: June 2, 2014
• First Submitted That Met QC Criteria: June 9, 2014
• First Posted (ESTIMATE): June 11, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 2, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Total Hip Replacement; Peripheral Nerve Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Pain, Postoperative; Osteoarthritis, Hip; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: PRO13030184