The Duration of Motor Block May Vary Between 12-36 HrsPhase 4NCT01272921

The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block

A Phase 4 study testing Bupivacaine and Ropivacaine in people with The Duration of Motor Block May Vary Between 12-36 Hrs, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The duration of motor block for infragluteal parabiceps sciatic nerve block following total knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic given. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: The Duration of Motor Block May Vary Between 12-36 Hrs
What is being tested?: Bupivacaine and Ropivacaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteUnited States
Study dates: Nov 2010to Aug 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients (>18 years of age) who are undergoing elective total knee arthroplasty will be included in the study.

Who cannot join

Exclusion criteria for the study are patient refusal to be included in the study, contraindications to regional anesthesia, history of allergy to amide local anesthetics, the presence of a progressive neurological deficit, the presence of coagulopathy or infection, or pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University, Feingberg School of Medicine
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Dose Response Study for Duration of Analgesia Using Bupivacaine and Ropivacaine for Infragluteal Parabiceps Sciatic Block

The duration of motor block for infragluteal parabiceps sciatic nerve block following total knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic given.

Conditions: The Duration of Motor Block May Vary Between 12-36 Hrs
Being tested: Bupivacaine, Ropivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BupivacaineDrug
Varying doses to determine the duration of analgesia
RopivacaineDrug
Varying doses to determine the duration of analgesia

Study groups in NCT01272921
Study group	Role	What they receive
Bupivacaine	Active comparator	Varying does to determine duration of analgesia following a sciatic nerve block Receives: Drug: Bupivacaine
Ropivacaine	Active comparator	Varying does to determine duration of analgesia following a sciatic nerve block Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL
Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator-assisted needle positioning beneath the common investing external layer (CIEL).
Measured: 3 days

Secondary outcomes (1)

Cumulative Probabilities for Needle Positioning Above and Below CIEL.
The cumulative probability distributions for the minimal current to evoke a motor response with the needle tip positioned external (above) to the common investing extraneural layer (CIEL) and the cumulative probability distribution for the needle tip postioned internal (below) to the CIEL were sought. The difference in the mean minimum threshold current (mA) for the external (above) and internal (below) CIEL positioning were calculated.
Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Aug 2012

First posted10 Jan 2011 (estimated)
Study startNov 2010
Primary completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for The Duration of Motor Block May Vary Between 12-36 HrsStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
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 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01272921
Sponsor's protocol ID: STU00035380
Status last verified: Mar 2017
First submitted: 7 Jan 2011
Last updated: 6 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Nader A, Kendall MC, De Oliveira GS Jr, Puri L, Tureanu L, Brodskaia A, Asher Y, Parimi V, McCarthy RJ. A dose-ranging study of 0.5% bupivacaine or ropivacaine on the success and duration of the ultrasound-guided, nerve-stimulator-assisted sciatic nerve block: a double-blind, randomized clinical trial. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):492-502. doi: 10.1097/AAP.0b013e3182a4bddf.
PubMed 24108248

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Response Study for Duration of Analgesia Using Bupivacaine and Ropivacaine for Infragluteal Parabiceps Sciatic Block
ClinicalTrials.gov ID: NCT01272921
Acronym / sponsor ID: STU00035380
Conditions: The Duration of Motor Block May Vary Between 12-36 Hrs
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: Nov 2010
Primary completion: Aug 2012 (actual)
First posted: 10 Jan 2011 (estimated)
Results: Posted 21 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The duration of motor block for infragluteal parabiceps sciatic nerve block following total knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic given.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bupivacaine	Active comparator	Drug: BupivacaineVarying does to determine duration of analgesia following a sciatic nerve block
Ropivacaine	Active comparator	Drug: RopivacaineVarying does to determine duration of analgesia following a sciatic nerve block

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients (>18 years of age) who are undergoing elective total knee arthroplasty will be included in the study.

Key exclusion criteria (1 listed)

Exclusion criteria for the study are patient refusal to be included in the study, contraindications to regional anesthesia, history of allergy to amide local anesthetics, the presence of a progressive neurological deficit, the presence of coagulopathy or infection, or pregnancy

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
BupivacaineVarying doses to determine the duration of analgesia	Drug	Bupivacaine
RopivacaineVarying doses to determine the duration of analgesia	Drug	Ropivacaine

Primary outcome

Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL
Time frame: 3 days
Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator-assisted needle positioning beneath the common investing external layer (CIEL).

1 secondary outcome

Cumulative Probabilities for Needle Positioning Above and Below CIEL.
Time frame: 1 Day

Results and safety

Results posted to the registry on 21 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bupivacaine	71	69
Ropivacaine	71	70

Primary outcome: Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL

Time frame: 3 days. Median (95% Confidence Interval). Unit: Hours

Measure	Bupivacaine n = 69	Ropivacaine n = 70
Motor: < 10ml	10 (4 to 14)	7 (5 to 10)
Motor: >/= 10ml	21 (17 to 22)	15 (14 to 15)
Sensory: <10ml	9 (6 to 14)	8 (6 to 12)
Sensory: >/= 10ml	20 (17 to 23)	14 (13 to 15)

Bupivacaine: Mean Difference (Final Values): -11.00 (95% CI -17.00 to -6.00), p = 0.05, Wilcoxon (Mann-Whitney)
Bupivacaine: Mean Difference (Final Values): -11.00 (95% CI -15.00 to -6.00), p = 0.05, Wilcoxon (Mann-Whitney)
Ropivacaine: Mean Difference (Final Values): -7.0 (95% CI -10.00 to -4.00), p = 0.05, Wilcoxon (Mann-Whitney)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Time frame for adverse event reporting was 12 months following surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GROUP 1	0 of 69 (0%)	0 of 69 (0%)	Not reported
GROUP 2	0 of 70 (0%)	0 of 70 (0%)	Not reported

Limitations and caveats (from the sponsor): We used 5-mL increments of local anesthetic w/epinephrine between 5-30 mL which may have prevented from identifying more precisely the volume at which onset/duration were similar.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24108248Nader A, Kendall MC, De Oliveira GS Jr, Puri L, Tureanu L, Brodskaia A, Asher Y, Parimi V, McCarthy RJ. A dose-ranging study of 0.5% bupivacaine or ropivacaine on the success and duration of the ultrasound-guided, nerve-stimulator-assisted sciatic nerve block: a double-blind, randomized clinical trial. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):492-502. doi: 10.1097/AAP.0b013e3182a4bddf.

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.

Antoun Nader, MD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine and Ropivacaine in people with The Duration of Motor Block May Vary Between 12-36 Hrs, run by Northwestern University 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 6 Apr 2017. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01272921, which also lists 1 linked publication.

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 6 Apr 2017.