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Osteoarthritis of HipNCT02161484

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

A study testing Continuous Lumbar Plexus Block, Parasacral Nerve Block and Ropivacine 0.2% in people with Osteoarthritis of Hip and Regional Anesthesia, run by Rita Merman at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Continuous Lumbar Plexus Block, Parasacral Nerve Block and Ropivacine 0.2%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jan 2014to 17 Jun 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has signed and dated an Informed Consent Form.
  • Subject is classified as a ASA (American Society of Anesthesiologists) status I-III
  • Subject is age 18- 75 years old.
  • Subject is having primary total hip arthroplasty
  • No contraindication to peripheral nerve catheter ( local infection or hypocoagulable state)
  • Patient willing to receive spinal anesthesia as operative anesthesia
  • No known drug allergies to study medications
  • Patients not expected to receive therapeutic anticoagulation in the postoperative period.

Who cannot join

  • Subject inability to provide adequate informed consent.
  • Age younger than 18 years or older than 75 years
  • Any contraindication to the placement of lumbar plexus catheter, including local infection, hypocoagulable state.
  • ASA (American Society of Anesthesiologists) physical status of IV or greater
  • Any chronic painful conditions
  • Preoperative opioid use
  • Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Continuous Lumbar Plexus Block, Parasacral Nerve Block, Ropivacine 0.2%, Bupivacaine 0.0625%
Keywords
Peripheral Nerve Block, Total Hip Replacement
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Lumbar Plexus BlockProcedure or surgery

    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 BlockProcedure or surgery

    Also called Sciatic 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.

  • 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.

Study groups in NCT02161484
Study groupRoleWhat they receive
Continuous Lumbar Plexus Block with Parasacral Nerve BlockExperimentalLumbar 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.
Receives: Procedure: Continuous Lumbar Plexus Block; Procedure: Parasacral Nerve Block; Drug: Ropivacine 0.2%; Drug: Bupivacaine 0.0625%
Lumbar Plexus Nerve BlockActive comparatorLumbar 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.
Receives: Procedure: Continuous Lumbar Plexus Block; Drug: Ropivacine 0.2%; Drug: Bupivacaine 0.0625%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 hours after the start of surgery

  2. 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.

    Measured: 24 hours after the start of surgery

  3. 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.

    Measured: 48 hours after the start of surgery

Secondary outcomes (5)
  1. Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively

    Measured: 48 hours after the start of the surgery

  2. Amount of Oxycodone for the First 48 h Post Operatively

    Including number of dose and mg).

    Measured: 48 hours after the start of the surgery

  3. Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively

    Measured: 48 hours after the start of the surgery

  4. Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively

    Measured: 48 hours after the start of the surgery

  5. Total Amount of Local Anesthetic in 48 Hours Post Operatively

    Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)

    Measured: 48 hours after the start of the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2014 (estimated)
  2. Study startJan 2014
  3. Primary completion17 Jun 2014
  4. Study completion17 Jun 2014

Why it stopped: The computer is crushed and all data is lost (IT was not able to recover it. Last data was collected 6.17.14)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02161484
Sponsor's protocol ID
PRO13030184
Status last verified
Mar 2018
First submitted
2 Jun 2014
Last updated
29 Mar 2018
Data monitoring committee
No

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.

    PubMed 19448235
  • 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.

    PubMed 12419722
  • 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.

    PubMed 9168212
  • 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.

    PubMed 17513661
  • 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.

    PubMed 21467563
  • 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.

    PubMed 19122076

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Lumbar Plexus Block, Parasacral Nerve Block and Ropivacine 0.2% in people with Osteoarthritis of Hip and Regional Anesthesia, run by Rita Merman at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Rating Scale (NRS) Pain Assessment (time frame: 6 hours after the start of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02161484, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.

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