Pain, PostoperativeNCT01332045
Continuous Saphenous Nerve Block for Total Knee Arthroplasty
A study testing continuous saphenous nerve block and Saline boluses in nerve catheter in people with Pain, Postoperative, run by Henning Lykke Andersen at 1 site in Denmark.
Trial summary
Our study will compare the use of continuous saphenous nerve block performed at the adductor canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to LIA for total knee replacement. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- continuous saphenous nerve block and Saline boluses in nerve catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Jan 2012
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Age: 40-75
- Unilateral TKA
- Use of Spinal anesthesia
Who cannot join
- Allergy to any of the study medications
- Intolerance to morphine
- Contraindication to a spinal anesthetic
- Intraoperative use of any volatile anesthetic
- Chronic opioid use
- ASA Class 4-5
Show all 10Show fewer
- Rheumatoid arthritis or Diabetes mellitus with neuropathy
- Liver or kidney failure
- BMI above 40
- Severe COPD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Saphenous Nerve Block (Adductor Channel) and Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty
Our study will compare the use of continuous saphenous nerve block performed at the adductor canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block performed at the level of the adductor canal in addition to LIA provides better pain relief than the LIA alone without significantly compromising muscle strength and physiotherapy, enabling patients to mobilize early with reduced opioid consumption and les side effects.
The investigators will enroll a total of 40 patients (20 patients will receive continuous saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until discharge, the investigators will record patients' pain scores, opioid consumption, side effects and physical therapy progress.
If our study proves that the continuous saphenous nerve block in addition to LIA can effectively reduce postoperative pain scores to an acceptable level with better physical therapy progress and less opioid consumption, it could be seen as a more attractive alternative to LIA alone or other traditionally used methods of postoperative pain control that compromises muscle strength and physiotherapy.
- Conditions
- Pain, Postoperative
- Being tested
- continuous saphenous nerve block, Saline boluses in nerve catheter
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous saphenous nerve blockProcedure or surgery
Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days
Saline boluses in nerve catheterProcedure or surgery
A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.
| Study group | Role | What they receive |
|---|---|---|
| Saline boluses in nerve catheter | Sham comparator | A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses. Receives: Procedure: Saline boluses in nerve catheter |
| Continuous saphenous nerve block | Active comparator | Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days Receives: Procedure: continuous saphenous nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
VAS pain scores
Measured: 3 days postoperative
Secondary outcomes (2)
Opioid consumption
Measured: 3 days postoperative
physical therapy progress
Measured: 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henning Lykke Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henning Lykke Andersen, Frederiksberg University Hospital
- Investigators
- Henning L. Andersen, M.D., Principal investigator, Frederiksberg HospitalDusanka Zaric, M.D., Ph.d., Study director, Frederiksberg Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332045
- Sponsor's protocol ID
- H-3-2010-124
- Status last verified
- Jan 2012
- First submitted
- 7 Apr 2011
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andersen HL, Gyrn J, Moller L, Christensen B, Zaric D. Continuous saphenous nerve block as supplement to single-dose local infiltration analgesia for postoperative pain management after total knee arthroplasty. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):106-11. doi: 10.1097/AAP.0b013e31827900a9.
PubMed 23222363
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Saphenous Nerve Block (Adductor Channel) and Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01332045
- Acronym / sponsor ID
- H-3-2010-124
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Henning Lykke AndersenUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Apr 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.
Our study will compare the use of continuous saphenous nerve block performed at the adductor canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block performed at the level of the adductor canal in addition to LIA provides better pain relief than the LIA alone without significantly compromising muscle strength and physiotherapy, enabling patients to mobilize early with reduced opioid consumption and les side effects.
The investigators will enroll a total of 40 patients (20 patients will receive continuous saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until discharge, the investigators will record patients' pain scores, opioid consumption, side effects and physical therapy progress.
If our study proves that the continuous saphenous nerve block in addition to LIA can effectively reduce postoperative pain scores to an acceptable level with better physical therapy progress and less opioid consumption, it could be seen as a more attractive alternative to LIA alone or other traditionally used methods of postoperative pain control that compromises muscle strength and physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline boluses in nerve catheter | Sham comparator | Procedure: Saline boluses in nerve catheterA nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses. |
| Continuous saphenous nerve block | Active comparator | Procedure: continuous saphenous nerve blockPostoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III
- Age: 40-75
- Unilateral TKA
- Use of Spinal anesthesia
Key exclusion criteria (10 listed)
- Allergy to any of the study medications
- Intolerance to morphine
- Contraindication to a spinal anesthetic
- Intraoperative use of any volatile anesthetic
- Chronic opioid use
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 |
|---|---|---|
| continuous saphenous nerve blockPostoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days | Procedure or surgery | Continuous saphenous nerve block |
| Saline boluses in nerve catheterA nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses. | Procedure or surgery | Saline boluses in nerve catheter |
Primary outcome
Pain scores
Time frame: 3 days postoperative
VAS pain scores
2 secondary outcomes
Opioid consumption
Time frame: 3 days postoperative
physical therapy progress
Time frame: 3 days postoperative
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 19 Jan 2012.
- Derived from this study: PubMed 23222363Andersen HL, Gyrn J, Moller L, Christensen B, Zaric D. Continuous saphenous nerve block as supplement to single-dose local infiltration analgesia for postoperative pain management after total knee arthroplasty. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):106-11. doi: 10.1097/AAP.0b013e31827900a9.
- Related InfoLink provided by the sponsor.
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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.
Henning L. Andersen, M.D. principal investigator
Frederiksberg Hospital
Dusanka Zaric, M.D., Ph.d. study director
Frederiksberg 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 continuous saphenous nerve block and Saline boluses in nerve catheter in people with Pain, Postoperative, run by Henning Lykke Andersen at 1 site in Denmark.
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 4 inclusion and 10 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 19 Jan 2012. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Pain scores (time frame: 3 days postoperative). 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 NCT01332045, 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 19 Jan 2012; AzTrials last refreshed its copy on 1 Nov 2026.