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

NCT ID: NCT02161484

Last Updated: 2018-03-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-06-17

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.

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Continuous Lumbar Plexus Block

Intervention Type 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.

Parasacral Nerve Block

Intervention Type 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%

Intervention Type 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%

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Continuous Lumbar Plexus Block

Intervention Type 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.

Ropivacine 0.2%

Intervention Type 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%

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Sciatic Nerve Block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rita Merman

OTHER

Sponsor Role lead

Responsible Party

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Rita Merman

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rita Merman, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Presbyterian Shadyside

Jacques E. Chelly, MD, PhD, MBA

Role: STUDY_CHAIR

UPMC Presbyterian Shadyside

Locations

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UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19448235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12419722 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9168212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17513661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21467563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19122076 (View on PubMed)

Other Identifiers

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PRO13030184

Identifier Type: -

Identifier Source: org_study_id

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