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Trial record 2 of 3 for:    total knee replacement | Lebanon

The Efficacy of Peripheral Nerve Blocks With Intrathecal Morphine in Improving Analgesia After Unilateral Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02135120
Recruitment Status : Active, not recruiting
First Posted : May 9, 2014
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ghassan Kanazi, American University of Beirut Medical Center

Brief Summary:
The purpose of this study is to determine whether intrathecal morphine (ITM) alone or its combination with peripheral nerve blocks (PNB) provides better analgesia for patients undergoing total knee arthroplasty (TKA).

Condition or disease Intervention/treatment Phase
Anesthesia Total Knee Arthroplasty Drug: Combined spinal epidural anesthesia technique with intrathecal morphine Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block Not Applicable

Detailed Description:

Total knee arthroplasty (TKA) surgery is associated with severe pain. The success of knee rehabilitation following surgery depends largely on adequate pain control that permits early physical therapy. Postoperative modern analgesic recommendations specific to TKA propose either spinal block with intrathecal morphine (ITM) or a combination of general anesthesia with single shot femoral nerve block (SFNB). Femoral nerve block (FNB) too has proven analgesic advantages in TKA surgery. However, we do not know if the combination of the two analgesic techniques, ITM and peripheral nerve blocks (PNB), provides superior analgesia to ITM alone.

Thus, this study aims to determine whether ITM alone or its combination with PNB provides better analgesia for patients undergoing total knee arthroplasty (TKA).

Eligible patients undergoing unilateral TKA under spinal anesthesia consenting to a multimodal analgesic regimen inclusive of ITM, FNB, and SNB will be recruited. All patients will receive spinal with intrathecal morphine. Patients will be randomly assigned using a computer generated table of random numbers to receive either spinal with intrathecal morphine (morphine group), a combination of intrathecal morphine and femoral nerve block (morphine-femoral group), or a combination of intrathecal morphine and femoral nerve block as well as sciatic nerve block (morphine-femoral-sciatic group).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Do Peripheral Nerve Blocks When Used as Part of a Multimodal Regimen Inclusive on Intrathecal Morphine Improve Analgesia After Unilateral Total Knee Arthroplasty? A Randomized Controlled Trial
Study Start Date : March 2013
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Morphine group
Patients will receive a combined spinal epidural anesthesia technique with intrathecal morphine
Drug: Combined spinal epidural anesthesia technique with intrathecal morphine
Active Comparator: Morphine-femoral group
Patients will receive a combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block
Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block
Active Comparator: Morphine-femoral-sciatic group
Patients will receive a combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block
Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block



Primary Outcome Measures :
  1. Postoperative parenteral morphine consumption [ Time Frame: first 24 hours post-operation ]

Secondary Outcome Measures :
  1. Visual analogue pain scores (VAS) in anterior and posterior knee [ Time Frame: within 24-48 hours after surgery ]
  2. Severity of pain in anterior and posterior knee [ Time Frame: 1 week postoperatively ]
  3. Time to first IV PCA bolus [ Time Frame: within first 12 hours ]
  4. Total IV PCA consumption upon discontinuation of PCA [ Time Frame: 24-48 hours after surgery ]
  5. Side effects [ Time Frame: within 24 hours after surgery ]
    Patients will be closely monitored during their hospital stay. Patients will be assessed in their rooms twice daily by a pain nurse, and additionally as required, to report the occurrence of side effects including: block complications, incidence of falls, numbness over femoral distribution, nausea & vomiting, pruritus, occurrence of urinary retention, occurrence of respiratory depression.

  6. Patient satisfaction with pain control [ Time Frame: 24-48 hours after surgery ]
  7. complications [ Time Frame: 1 month after surgery ]
    Patients will be contacted by a member of the research team (by phone) to check for complications including: numbness in the anterior thigh, numbness in the foot, pain and/or bruising around the site where the anesthetic were injected, weakness in thigh muscles, weakness in foot muscles



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I-III patients undergoing unilateral TKA under spinal anesthesia and nerve blocks
  • Ages 18-80
  • BMI ≤ 38 kg/m2

Exclusion Criteria:

  • BMI > 38 kg/m2
  • chronic pain disorders
  • Significant pre-existing neurological deficits or peripheral neuropathy affecting the lower extremity
  • abuse of drugs or alcohol
  • Contraindication to a component of multi-modal analgesia
  • Contraindication to spinal anesthesia or failure to institute spinal anesthesia after performing femoral and sciatic blocks
  • Bilateral TKA surgeries
  • History of significant psychiatric conditions that may affect patient assessment
  • Pregnancy
  • Moderate to severe obstructive sleep apnea.
  • Previous adverse reactions resulting from intrathecal opioids (respiratory depression, urinary retention, severe pruritis, severe nausea or vomiting, severe sedation)
  • inability to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135120


Locations
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Ghassan E Kanazi, MD American Univesity of Beirut Medical Center

Responsible Party: Ghassan Kanazi, Professor and Chairman, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02135120     History of Changes
Other Study ID Numbers: ANES.GK.09
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Anesthetics
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents