Post Operative AnalgesiaNCT01415193
Tibial Nerve Versus Sciatic Nerve Block
A study testing Selective Tibial Nerve block and Sciatic Nerve Block in people with Post Operative Analgesia, run by Trinity Health Of New England at 1 site in United States.
Trial summary
The purpose of this study is to analyse the ability to selectively block the posterior tibial nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking the posterior tibial nerve will give the same post-operative pain relief after total knee surgery compared to a sciatic nerve block. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post Operative Analgesia
- What is being tested?
- Selective Tibial Nerve block and Sciatic Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- total knee replacement
Who cannot join
- History of neuralgia, diabetes, pregnancy, allergy to local anesthetic solutions
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
About this study
Official title: Selective Tibial Nerve Block vs Popliteal Sciatic Nerve Block in Patients Having Total Knee Arthroplasty
The purpose of this study is to analyse the ability to selectively block the posterior tibial nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking the posterior tibial nerve will give the same post-operative pain relief after total knee surgery compared to a sciatic nerve block.
- Conditions
- Post Operative Analgesia
- Being tested
- Selective Tibial Nerve block, Sciatic Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Tibial Nerve blockProcedure or surgery
Use of selective pain block.
Sciatic Nerve BlockProcedure or surgery
Use of Sciatic Nerve Block
| Study group | Role | What they receive |
|---|---|---|
| Selective Tibial Nerve Block | Experimental | Not described Receives: Procedure: Selective Tibial Nerve block |
| Control: Sciatic Nerve Block | Active comparator | Not described Receives: Procedure: Sciatic Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop.
Measure frequency of foot drop in two groups and compare results.
Measured: Upon emergence from general anesthesia and up to 48 hours in the recovery room.
Secondary outcomes (1)
To assess if levels of pain and analgesic requirements are similar between the two groups.
Administer pain scale and monitor use of analgesics to compare levels two groups.
Measured: 24 hours after total knee replacement surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startMar 2009
- Primary completionMar 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Sinha, MD, Principal investigator, Saint Francis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415193
- Sponsor's protocol ID
- 09-02-002
- Status last verified
- Aug 2011
- First submitted
- 1 Aug 2011
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Tibial Nerve Block vs Popliteal Sciatic Nerve Block in Patients Having Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01415193
- Acronym / sponsor ID
- 09-02-002
- Conditions
- Post Operative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Aug 2011 (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 analyse the ability to selectively block the posterior tibial nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking the posterior tibial nerve will give the same post-operative pain relief after total knee surgery compared to a sciatic nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective Tibial Nerve Block | Experimental | Procedure: Selective Tibial Nerve block |
| Control: Sciatic Nerve Block | Active comparator | Procedure: Sciatic Nerve Block |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- total knee replacement
Key exclusion criteria (1 listed)
- History of neuralgia, diabetes, pregnancy, allergy to local anesthetic solutions
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 |
|---|---|---|
| Selective Tibial Nerve blockUse of selective pain block. | Procedure or surgery | Selective Tibial Nerve Block |
| Sciatic Nerve BlockUse of Sciatic Nerve Block | Procedure or surgery | Control: Sciatic Nerve Block |
Primary outcome
To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop.
Time frame: Upon emergence from general anesthesia and up to 48 hours in the recovery room.
Measure frequency of foot drop in two groups and compare results.
1 secondary outcome
To assess if levels of pain and analgesic requirements are similar between the two groups.
Time frame: 24 hours after total knee replacement 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 18 Mar 2015.
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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.
Sanjay Sinha, MD principal investigator
Saint Francis Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Tibial Nerve block and Sciatic Nerve Block in people with Post Operative Analgesia, run by Trinity Health Of New England at 1 site in United States.
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 1 inclusion and 1 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 18 Mar 2015. 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 United States. 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?
To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop. (time frame: Upon emergence from general anesthesia and up to 48 hours in the recovery room.). 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 18 Mar 2015.