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The computer is crushed and all data is lost (IT was not able to recover it. Last data was collected 6.17.14)
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Lumbar Plexus Block with Parasacral Nerve Block | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Lumbar Plexus Block | Procedure | 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. |
| 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 |
| 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). |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita Merman, MD | UPMC Presbyterian Shadyside | Principal Investigator |
| Jacques E. Chelly, MD, PhD, MBA | UPMC Presbyterian Shadyside | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Shadyside | Pittsburgh | Pennsylvania | 15232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19448235 | Background | 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. | |
| 12419722 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Parasacral Nerve Block | Procedure | A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected. |
|
|
| Ropivacine 0.2% | Drug | 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. |
|
| Bupivacaine 0.0625% | Drug | 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. |
|
| 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 |
| 9168212 | Background | 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. |
| 17513661 | Background | 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. |
| 21467563 | Background | 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. |
| 19122076 | Background | 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. |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 hours after the start of surgery |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 24 hours after the start of surgery |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 48 hours after the start of surgery |
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| Secondary | Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively | Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively. | Posted | 48 hours after the start of the surgery |
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| Secondary | Amount of Oxycodone for the First 48 h Post Operatively | Including number of dose and mg). | Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively. | Posted | 48 hours after the start of the surgery |
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| Secondary | Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively | Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively. | Posted | 48 hours after the start of the surgery |
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| Secondary | Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively | Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively. | Posted | 48 hours after the start of the surgery |
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| Secondary | Total Amount of Local Anesthetic in 48 Hours Post Operatively | Combined amount of Bupivacaine Boluses + Continuous infusion in (cc) | Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively. | Posted | 48 hours after the start of the surgery |
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| Other Pre-specified | Incidence of Complications (e.g. Frequency of Foot-drop). | Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, "Foot Drop", allergic reaction will be recorded | Posted | Number | Number of complications | 48 hours after the start of the surgery |
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From enrollment until 48 hours post-operatively or discharge from the hospital, whichever occurs first
In addition to regular monitoring, questionnaires were given at 48 hours post-operatively to assess drug toxicity signs such as: numbness, ringing in ears, vision problems, motor weakness, metallic taste, etc.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG001 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rita Merman, P.I. | University of Pittsburgh | 41256322137 | MermanRB@upmc.edu |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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