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

A

American University of Beirut Medical Center

Status

Completed

Conditions

Total Knee Arthroplasty
Anesthesia

Treatments

Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block
Drug: Combined spinal epidural anesthesia technique with intrathecal morphine
Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block

Study type

Interventional

Funder types

Other

Identifiers

NCT02135120
ANES.GK.09

Details and patient eligibility

About

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).

Full 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).

Enrollment

42 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

42 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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