Total Hip Arthroplasty Clinical Trial
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
Verified date | March 2018 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | June 17, 2014 |
Est. primary completion date | June 17, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Presbyterian Shadyside | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Rita Merman |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively | 48 hours after the start of the surgery | ||
Secondary | Amount of Oxycodone for the First 48 h Post Operatively | Including number of dose and mg). | 48 hours after the start of the surgery | |
Secondary | Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively | 48 hours after the start of the surgery | ||
Secondary | Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively | 48 hours after the start of the surgery | ||
Secondary | 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 |
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