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Completed

NCT Number: NCT02135120

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

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).

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Key information

Conditions

Anesthesia Total Knee Arthroplasty

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut Medical Center

Beirut, Lebanon

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Primary outcomes

  1. Postoperative parenteral morphine consumption

    Time frame: first 24 hours post-operation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 9, 2014
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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