Clinical trial NCT02161484: 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
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Numeric Rating Scale (NRS) Pain Assessment
timeFrame: 6 hours after the start of surgery
measure: Numeric Rating Scale (NRS) Pain Assessment
timeFrame: 24 hours after the start of surgery
measure: Numeric Rating Scale (NRS) Pain Assessment
timeFrame: 48 hours after the start of surgery
Secondary outcomes:
measure: Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively
timeFrame: 48 hours after the start of the surgery
measure: Amount of Oxycodone for the First 48 h Post Operatively
timeFrame: 48 hours after the start of the surgery
measure: Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively
timeFrame: 48 hours after the start of the surgery
measure: Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively
timeFrame: 48 hours after the start of the surgery
measure: Total Amount of Local Anesthetic in 48 Hours Post Operatively
timeFrame: 48 hours after the start of the surgery
Other outcomes:
measure: Incidence of Complications (e.g. Frequency of Foot-drop).
timeFrame: 48 hours after the start of the surgery
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Shadyside
state: Pennsylvania
Study officials:
affiliation: UPMC Presbyterian Shadyside
name: Rita Merman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UPMC Presbyterian Shadyside
name: Jacques E. Chelly, MD, PhD, MBA
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.