Major Ankle SurgeryNCT01445210
Saphenous Nerve Block: Single Shot Versus Continuous Infusion to Supplement a Continuous Sciatic Nerve Block After Major Ankle Surgery
A study testing Continuous saphenous nerve block in people with Major Ankle Surgery, run by University of Aarhus at 1 site in Denmark.
Trial summary
The most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve. Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Ankle Surgery
- What is being tested?
- Continuous saphenous nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- total ankle arthroplasty
- subtalar fusion
- ankle fusion (non arthroscopic)
Who cannot join
- coagulation abnormalities
- infection in the region of needle insertion
- systemic infection
- preoperative consumption of high dose opioid
- preoperative sciatic or femoral nerve neuropathy
- preoperative sensory deficit in either of the lower extremities
Show all 16Show fewer
- Charcot-Marie-Tooth disorder
- diabetic neuropathy
- severe peripheral vascular disease
- allergy to local anesthetics
- lack of understanding of Numeric Rank Scale (NRS)
- communication problems
- dementia
- body mass index above 35
- bilateral continuous sciatic nerve block
- lack of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of Single Injection vs. Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block in Postoperative Pain Treatment After Major Ankle Surgery: Clinical Outcome and Cost Analysis
The most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve.
Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve.
Read more
Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared.
The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.
Read the detailed description
Major ankle surgery are known to be very painful the first 48 hours after the operation due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, respiratory depression).
Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics. Today such a continuous sciatic nerve block is part of the standard pain treatment after major ankle surgery on Aarhus University Hospital. Despite accurate placement of the catheter many patients are in great pain because the saphenous nerve remain unaffected. A single injection block relieve the pain but a block with Ropivacaine only last 8-15 hours.
Severe postoperative pain leads to high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.
The aim of the study establish whether continuous saphenous nerve block is efficient (pain relief or reduced opioid consumption) and justified (cost-effectiveness analysis) compared with single injection block.
- Conditions
- Major Ankle Surgery
- Being tested
- Continuous saphenous nerve block, Placebo
- Keywords
- Postoperative pain, Major ankle surgery, Continuous nerve block, Saphenous nerve, Ropivacaine
- 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
Also called Naropin
0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
PlaceboProcedure or surgery
Isoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
| Study group | Role | What they receive |
|---|---|---|
| 0,2% Ropivacaine | Active comparator | Patients randomized to the experimental group receive a continuous infusion of 0,2 % Ropivacaine by elastomeric infusion pump at 5 ml/h in the saphenous catheter after major ankle surgery. Infusion for 48 postoperative hours.
All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block. Receives: Procedure: Continuous saphenous nerve block |
| Control | Placebo comparator | Patients randomized to the control group receive a continuous infusion of isoton saline by elastomeric infusion pump at 5 ml/h in their catheter after major ankle surgery. Infusion for 48 postoperative hours.
All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated opioid consumption
Measured: First 48 hours postoperative
Secondary outcomes (5)
Success rate for saphenous nerve analgesia
Pain rated by NRS and opioid consumption
Measured: Postoperative, first 48 hours
Success rate for clinical analgesia of foot and ankle
Pain rated by NRS and opioid consumption
Measured: Postoperative, first 48 hours
Success rate for tibial and peroneal nerve block
Pain rated by NRS and test of sensation on the toes
Measured: Postoperative, first 48 hours
Localisation of worst pain
Measured: Postoperative, first 48 hours
Cost-effectiveness
Measured: 2 first postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 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 Major Ankle SurgeryStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Thomas F Bendtsen, ph.d., MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445210
- Sponsor's protocol ID
- 2011-0184
- Status last verified
- Oct 2012
- First submitted
- 29 Sep 2011
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fisker AK, Iversen BN, Christensen S, Linde F, Nielsen KK, Borglum J, Bendtsen TF. Combined saphenous and sciatic catheters for analgesia after major ankle surgery: a double-blinded randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):875-82. doi: 10.1007/s12630-015-0379-y. Epub 2015 Apr 8.
PubMed 25851020
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Single Injection vs. Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block in Postoperative Pain Treatment After Major Ankle Surgery: Clinical Outcome and Cost Analysis
- ClinicalTrials.gov ID
- NCT01445210
- Acronym / sponsor ID
- 2011-0184
- Conditions
- Major Ankle Surgery
- Keywords
- Postoperative pain, Major ankle surgery, Continuous nerve block, Saphenous nerve, Ropivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Oct 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 most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve.
Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve.
Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared.
The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.
Detailed description
Major ankle surgery are known to be very painful the first 48 hours after the operation due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, respiratory depression).
Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics. Today such a continuous sciatic nerve block is part of the standard pain treatment after major ankle surgery on Aarhus University Hospital. Despite accurate placement of the catheter many patients are in great pain because the saphenous nerve remain unaffected. A single injection block relieve the pain but a block with Ropivacaine only last 8-15 hours.
Severe postoperative pain leads to high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.
The aim of the study establish whether continuous saphenous nerve block is efficient (pain relief or reduced opioid consumption) and justified (cost-effectiveness analysis) compared with single injection block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0,2% Ropivacaine | Active comparator | Procedure: Continuous saphenous nerve blockPatients randomized to the experimental group receive a continuous infusion of 0,2 % Ropivacaine by elastomeric infusion pump at 5 ml/h in the saphenous catheter after major ankle surgery. Infusion for 48 postoperative hours. All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block. |
| Control | Placebo comparator | Procedure: PlaceboPatients randomized to the control group receive a continuous infusion of isoton saline by elastomeric infusion pump at 5 ml/h in their catheter after major ankle surgery. Infusion for 48 postoperative hours. All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- total ankle arthroplasty
- subtalar fusion
- ankle fusion (non arthroscopic)
Key exclusion criteria (16 listed)
- coagulation abnormalities
- infection in the region of needle insertion
- systemic infection
- preoperative consumption of high dose opioid
- preoperative sciatic or femoral nerve neuropathy
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 blockAlso: Naropin0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours | Procedure or surgery | 0,2% Ropivacaine |
| PlaceboIsoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours | Procedure or surgery | Control |
Primary outcome
Accumulated opioid consumption
Time frame: First 48 hours postoperative
5 secondary outcomes
Success rate for saphenous nerve analgesia
Time frame: Postoperative, first 48 hours
Success rate for clinical analgesia of foot and ankle
Time frame: Postoperative, first 48 hours
Success rate for tibial and peroneal nerve block
Time frame: Postoperative, first 48 hours
Localisation of worst pain
Time frame: Postoperative, first 48 hours
Cost-effectiveness
Time frame: 2 first postoperative days
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 Oct 2012.
- Derived from this study: PubMed 25851020Fisker AK, Iversen BN, Christensen S, Linde F, Nielsen KK, Borglum J, Bendtsen TF. Combined saphenous and sciatic catheters for analgesia after major ankle surgery: a double-blinded randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):875-82. doi: 10.1007/s12630-015-0379-y. Epub 2015 Apr 8.
Related trials for Major Ankle Surgery
Enrolling by invitationPhase 4
Liposomal Bupivacaine Versus Continuous Peripheral Nerve Blocks for Analgesia Following Ankle Surgery
Moderate-to-severely Painful Ankle Surgery
RecruitingObservational study
Outcomes of Surgical Treatment Using a Custom-made Device for Total Ankle and Talar Replacement in the Management of Severe Cases of Bone Loss or Bone Compromise: a Pilot Study.
Arthrosis, Ankle Arthritis
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.
Thomas F Bendtsen, ph.d., MD principal investigator
Aarhus University 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 in people with Major Ankle Surgery, run by University of Aarhus 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 3 inclusion and 16 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 Oct 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?
Accumulated opioid consumption (time frame: First 48 hours 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 NCT01445210, 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 Oct 2012.