AnesthesiaNCT02135120
The Efficacy of Peripheral Nerve Blocks With Intrathecal Morphine in Improving Analgesia After Unilateral Total Knee Arthroplasty
A study testing Combined spinal epidural anesthesia technique with intrathecal morphine, A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block and A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block in people with Anesthesia and Total Knee Arthroplasty, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Total Knee Arthroplasty
- What is being tested?
- Combined spinal epidural anesthesia technique with intrathecal morphine, A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block and A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteLebanon
- Study dates
- Mar 2013to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-III patients undergoing unilateral TKA under spinal anesthesia and nerve blocks
- Ages 18-80
- BMI ≤ 38 kg/m2
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Conditions
- Anesthesia, Total Knee Arthroplasty
- Being tested
- Combined spinal epidural anesthesia technique with intrathecal morphine, A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block, A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined spinal epidural anesthesia technique with intrathecal morphineDrug
A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve blockDrug
A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve blockDrug
| Study group | Role | What they receive |
|---|---|---|
| Morphine group | Active comparator | Patients will receive a combined spinal epidural anesthesia technique with intrathecal morphine Receives: 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 Receives: 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 Receives: Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative parenteral morphine consumption
Measured: first 24 hours post-operation
Secondary outcomes (7)
Visual analogue pain scores (VAS) in anterior and posterior knee
Measured: within 24-48 hours after surgery
Severity of pain in anterior and posterior knee
Measured: 1 week postoperatively
Time to first IV PCA bolus
Measured: within first 12 hours
Total IV PCA consumption upon discontinuation of PCA
Measured: 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.
Measured: within 24 hours after surgery
Patient satisfaction with pain control
Measured: 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
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startMar 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghassan Kanazi, American University of Beirut Medical Center
- Investigators
- Ghassan E Kanazi, MD, Principal investigator, American Univesity of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135120
- Sponsor's protocol ID
- ANES.GK.09
- Status last verified
- Jan 2019
- First submitted
- 7 May 2014
- Last updated
- 10 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02135120
- Acronym / sponsor ID
- ANES.GK.09
- Conditions
- Anesthesia, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morphine group | Active comparator | Drug: Combined spinal epidural anesthesia technique with intrathecal morphinePatients will receive a combined spinal epidural anesthesia technique with intrathecal morphine |
| Morphine-femoral group | Active comparator | Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve blockPatients will receive a combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block |
| Morphine-femoral-sciatic group | Active comparator | Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve blockPatients will receive a combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III patients undergoing unilateral TKA under spinal anesthesia and nerve blocks
- Ages 18-80
- BMI ≤ 38 kg/m2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Postoperative parenteral morphine consumption
Time frame: first 24 hours post-operation
7 secondary outcomes
Visual analogue pain scores (VAS) in anterior and posterior knee
Time frame: within 24-48 hours after surgery
Severity of pain in anterior and posterior knee
Time frame: 1 week postoperatively
Time to first IV PCA bolus
Time frame: within first 12 hours
Total IV PCA consumption upon discontinuation of PCA
Time frame: 24-48 hours after surgery
Side effects
Time frame: within 24 hours after surgery
Patient satisfaction with pain control
Time frame: 24-48 hours after surgery
complications
Time frame: 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghassan E Kanazi, MD principal investigator
American Univesity of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined spinal epidural anesthesia technique with intrathecal morphine, A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block and A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block in people with Anesthesia and Total Knee Arthroplasty, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative parenteral morphine consumption (time frame: first 24 hours post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.