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

NCT02135120 | Completed

• 1 other identifier: ANES.GK.09
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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).

Conditions

Anesthesia; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Postoperative parenteral morphine consumption

  first 24 hours post-operation

Secondary Outcomes (7)

• 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

  within 24 hours after surgery

Study Arms (3)

Morphine group

ACTIVE COMPARATOR

Patients will receive a combined spinal epidural anesthesia technique with intrathecal morphine

Drug: Combined spinal epidural anesthesia technique with intrathecal morphine

Morphine-femoral group

ACTIVE COMPARATOR

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

Morphine-femoral-sciatic group

ACTIVE COMPARATOR

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

Interventions

Combined spinal epidural anesthesia technique with intrathecal morphine DRUG

Morphine group

A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block DRUG

Morphine-femoral group

A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block DRUG

Morphine-femoral-sciatic group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

Study Officials

• Ghassan E Kanazi, MD

  American Univesity of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: March 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

LE (1)