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

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

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).

Study Overview

• Status: Completed
• Conditions: Anesthesia; Total Knee Arthroplasty
• Intervention / Treatment: 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

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
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative parenteral morphine consumption	first 24 hours post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue pain scores (VAS) in anterior and posterior knee		within 24-48 hours after surgery
Severity of pain in anterior and posterior knee		1 week postoperatively
Time to first IV PCA bolus		within first 12 hours
Total IV PCA consumption upon discontinuation of PCA		24-48 hours after surgery
Side effects	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.	within 24 hours after surgery
Patient satisfaction with pain control		24-48 hours after surgery
complications	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	1 month after surgery

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Ghassan E Kanazi, MD, American Univesity of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: ANES.GK.09