Hallux ValgusPhase 4NCT02293330
Continuous Versus Automated Bolus Infusion in Sciatic Nerve Catheters
A Phase 4 study testing continuous infusion of levobupivacaine and Intermittent bolus infusion of levobupivacaine in people with Hallux Valgus and Surgery, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
This study is developed to determine if the local anaesthetic dose can be reduced by the use of intermittent bolus technique compared to continuous infusion when the nerve catheter is placed underneath the paraneurium by ultrasound guidance in the popliteal fossa. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus, Surgery
- What is being tested?
- continuous infusion of levobupivacaine and Intermittent bolus infusion of levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Nov 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- scheduled for for surgery for hallux valgus pathology with general anesthesia and a popliteal nerve catheter (=sciatic nerve block)
Who cannot join
- neuromuscular disease,
- chronic pain,
- peripheral neuropathy in lower limb,
- contraindication for popliteal nerve block,
- unable to use pca (patient controlled analgesia),
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Infusion Versus Automated Intermittent Bolus of Levobupivacaine 0,1% in Ultrasound Guided Subparaneural Sciatic Nerve Catheters. A Prospective Double Blind Randomised Study.
This study is developed to determine if the local anaesthetic dose can be reduced by the use of intermittent bolus technique compared to continuous infusion when the nerve catheter is placed underneath the paraneurium by ultrasound guidance in the popliteal fossa. Our primary outcome is local anesthetic use the first 48 hours after connecting the peripheral nerve catheter. Our hypothesis is that with an intermittent bolus less local anaesthetic is necessary the first postoperative 48 hours after surgery for adequate postoperative analgesia. As secondary outcomes the investigators study pain scores, motor block, sensory block, feeling of numbness, patient satisfaction, sleep quality and rescue analgesia during the nerve block and afterwards.
Read the detailed description
Patients scheduled for foot surgery under general anaesthesia and a popliteal nerve catheter will be asked to take part and give informed consent. The anaesthesiologist performing the block, the patient and the independent observer will be blinded to the study group and the settings of the pump (CADD®-Solis) will be regulated and the data collected after 48 hours by an independent pain nurse or anaesthetist who is aware of the study group but does not register any other parameters.
Patients will be randomised by a computer-generated sequence, concealed by sealed envelopes. The envelope will be opened and the pump prepared by an independent pain nurse or anaesthesiologist who will not participate in registration of the parameters except extracting information out of the pump when the catheter is removed.
We expect to detect a 20 % increase in local anaesthetic dose for the continuous administration group (230 mg/48 hour). We used a standard deviation of 25%(58 mg) from a previous study. The minimum sample size required is 20 patients per group for a power of 80% with a 2-tailed significance level of 5%. We decided to include 25 patients in each group.
Before surgery
An IV access and standard monitoring is used throughout the procedure. A pre puncture scan will be performed and an experienced anaesthesiologist will perform all blocks. The block is performed in the lateral decubitus with a 12-18 MHz (megahertz) linear probe (BK medical®) and a solo long needle-catheter set (Pajunk®,18 gauge needle, 20 gauge catheter). The nerve will be visualised in a short axis image and the puncture will be done out of plane. Confirmation of accurate needle tip position will be confirmed by injection of nacl 0,9% (sodium chloride) and the appearance of a "twin- or triple halo sign". After confirmation of correct needle tip position 15 ml levobupivacaine 0,25% (chirocaine® Abbot)will be injected in between de peroneal and tibial nerve as an initial bolus. After injection a will be advanced 4 cm beyond the needle tip.
Correct catheter placement will be confirmed by ultrasound. A detailed description of block performance will be registered according to our standard hospital policy. The sensory block of the peroneal and tibial nerve will be separately tested by loss of cold sensation before transfer to the operating room, at least 20 minutes after the initial injection of lidocaine. When no block is detected it is considered as a block failure and the patient will be excluded from the study.
After performing the popliteal block the patients will be transferred to the operating room and receive general anaesthesia by an independent anaesthesiologist. Surgery will be performed with a tourniquet at 300 mm Hg. Standard monitoring is used during surgery (ecg, pulse oximetry and non invasive blood pressure measurement). Duration of surgery will be registered.
After the operation the patient will be transferred to the recovery room. Here the popliteal catheter will be connected pain pump (which will be defined as t=0) with an infusion protocol according to the study group:
C group: continuous infusion of levobupivacaine 0,125% (chirocaine ®, Abbot) B group: Intermittent bolus of levobupivacaine 0,125 ( chirocaine®Abbot) Both groups will have the possibility of administering a pca (patient controlled analgesia) bolus of 6 ml.
The Pump (CADD®-Solis Smiths medical) which will be started in the recovery room by an independent pain nurse or anaesthetist who is aware of the appointed study group (C group or B group). Pain scores ,motor block,sensory block and presence of numbness will be registered when the patient is awake enough to evaluate these parameters.
The patient will then be transferred to the ward after clear instructions of how to use the pain pump.The study will continue until 48 hours after starting the pump. Pain scores will be registered every four hours at the ward as well as feeling of numbness and sleep quality at regular intervals. During night hours (00-06)when the patient is sleeping pain scores will be registered as "S".When pain control is insufficient at the PACU or on the ward patients will receive paracetamol 1gr IV(Paracetamol® )and ketorolac (taradyal®) 30 mg IV. Tramadol ( contramal ®) 2 mg/kg will be given as rescue analgesia. On day one rescue analgesia will be provided orally .
All rescue analgesia or other medication will be registered.
48 hours after starting the pain pump the pump will be removed and all data will be collected and filed by an independent pain nurse or anaesthetist. This file will consist of a detailed description of the history of local anaesthetic administered, including total anaesthetic dose at 6,12,24 and 48 hours , frequency of extra boluses required and time intervals.
Before removing the nerve catheter the depth of the catheter is checked and bolus of nacl will be infused under ultrasound guidance and if possible correct placement can be confirmed after two days. Then the catheter will be removed.
After stopping the pump the patient will be asked if he or she was satisfied by the postoperative analgesic technique:
- Satisfied
- Sufficient
- Not satisfied
The patient is discharged but is asked to register the exact time point when sensation and motor function (when a motor block was present) after catheter removal appeared. The patient will be called two days after discharge to register these parameters.
- Conditions
- Hallux Valgus, Surgery
- Being tested
- continuous infusion of levobupivacaine, Intermittent bolus infusion of levobupivacaine
- Keywords
- continuous versus intermittent bolus sciatic nerve block
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous infusion of levobupivacaineDrug
Also called chirocaine
continuous infusion of levobupivacaine 0,125% at 5 ml/h , bolus dose 6 ml, lock out 30 minutes 4 hours limit: 60 ml/h
Intermittent bolus infusion of levobupivacaineDrug
Also called chirocaine
Intermittent bolus of levobupivacaine 0,125%: 0.1 ml /h and 9,8 ml bolus every two hours. Optional patient controlled bolus dose 6 ml, lock out 30 minutes, 4 hours limit: 60 ml/h
| Study group | Role | What they receive |
|---|---|---|
| C group | Experimental | continuous infusion of levobupivacaine Receives: Drug: continuous infusion of levobupivacaine |
| B group | Experimental | Intermittent bolus infusion of levobupivacaine Receives: Drug: Intermittent bolus infusion of levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
local anesthetic dose in 48 hours
the total amount of local anesthetic dose (mg) in total administered by the pump connected to the sciatic nerve catheter from start of the pump until stop ( 48 hours after start)
Measured: 48 hours
Secondary outcomes (5)
pains scores
pain scores on a numeric rating scale (0-10) will b scored on regular intervals ( every 4 hours)
Measured: 48 hours
motor block (possibility of tow movement ( yes/no)
possibility of tow movement ( yes/no) 6,12,24,30,36 and 48 hours after starting the pump)
Measured: 48 hours
sensory block loss of cold sensation (yes/no)
loss of cold sensation ( yes/no) in peroneal an tibial dermatome , measured at 6,12,24,30,36 hours after starting the pump
Measured: 48 hours
numbness (sensation of numbness (0 = no, 1= yes but not disturbing, 2= yes and disturbing)
sensation of numbness (0 = no, 1= yes but not disturbing, 2= yes and disturbing) measured at 6,12,24,30,36,48 hours after starting the pump
Measured: 48 hours
patient satisfaction 9satisfaction on a 10 point scal ( 0= very dissatisfied, 10 = very satisfied)
satisfaction on a 10 point scal ( 0= very dissatisfied, 10 = very satisfied)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr M. B. Breebaart, University Hospital, Antwerp
- Investigators
- Margaretha Breebaart, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293330
- Sponsor's protocol ID
- 14/38/393
- Status last verified
- Nov 2016
- First submitted
- 30 Oct 2014
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion Versus Automated Intermittent Bolus of Levobupivacaine 0,1% in Ultrasound Guided Subparaneural Sciatic Nerve Catheters. A Prospective Double Blind Randomised Study.
- ClinicalTrials.gov ID
- NCT02293330
- Acronym / sponsor ID
- 14/38/393
- Conditions
- Hallux Valgus, Surgery
- Keywords
- continuous versus intermittent bolus sciatic nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Nov 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.
This study is developed to determine if the local anaesthetic dose can be reduced by the use of intermittent bolus technique compared to continuous infusion when the nerve catheter is placed underneath the paraneurium by ultrasound guidance in the popliteal fossa. Our primary outcome is local anesthetic use the first 48 hours after connecting the peripheral nerve catheter. Our hypothesis is that with an intermittent bolus less local anaesthetic is necessary the first postoperative 48 hours after surgery for adequate postoperative analgesia. As secondary outcomes the investigators study pain scores, motor block, sensory block, feeling of numbness, patient satisfaction, sleep quality and rescue analgesia during the nerve block and afterwards.
Detailed description
Patients scheduled for foot surgery under general anaesthesia and a popliteal nerve catheter will be asked to take part and give informed consent. The anaesthesiologist performing the block, the patient and the independent observer will be blinded to the study group and the settings of the pump (CADD®-Solis) will be regulated and the data collected after 48 hours by an independent pain nurse or anaesthetist who is aware of the study group but does not register any other parameters.
Patients will be randomised by a computer-generated sequence, concealed by sealed envelopes. The envelope will be opened and the pump prepared by an independent pain nurse or anaesthesiologist who will not participate in registration of the parameters except extracting information out of the pump when the catheter is removed.
We expect to detect a 20 % increase in local anaesthetic dose for the continuous administration group (230 mg/48 hour). We used a standard deviation of 25%(58 mg) from a previous study. The minimum sample size required is 20 patients per group for a power of 80% with a 2-tailed significance level of 5%. We decided to include 25 patients in each group.
Before surgery
An IV access and standard monitoring is used throughout the procedure. A pre puncture scan will be performed and an experienced anaesthesiologist will perform all blocks. The block is performed in the lateral decubitus with a 12-18 MHz (megahertz) linear probe (BK medical®) and a solo long needle-catheter set (Pajunk®,18 gauge needle, 20 gauge catheter). The nerve will be visualised in a short axis image and the puncture will be done out of plane. Confirmation of accurate needle tip position will be confirmed by injection of nacl 0,9% (sodium chloride) and the appearance of a "twin- or triple halo sign". After confirmation of correct needle tip position 15 ml levobupivacaine 0,25% (chirocaine® Abbot)will be injected in between de peroneal and tibial nerve as an initial bolus. After injection a will be advanced 4 cm beyond the needle tip.
Correct catheter placement will be confirmed by ultrasound. A detailed description of block performance will be registered according to our standard hospital policy. The sensory block of the peroneal and tibial nerve will be separately tested by loss of cold sensation before transfer to the operating room, at least 20 minutes after the initial injection of lidocaine. When no block is detected it is considered as a block failure and the patient will be excluded from the study.
After performing the popliteal block the patients will be transferred to the operating room and receive general anaesthesia by an independent anaesthesiologist. Surgery will be performed with a tourniquet at 300 mm Hg. Standard monitoring is used during surgery (ecg, pulse oximetry and non invasive blood pressure measurement). Duration of surgery will be registered.
After the operation the patient will be transferred to the recovery room. Here the popliteal catheter will be connected pain pump (which will be defined as t=0) with an infusion protocol according to the study group:
C group: continuous infusion of levobupivacaine 0,125% (chirocaine ®, Abbot) B group: Intermittent bolus of levobupivacaine 0,125 ( chirocaine®Abbot) Both groups will have the possibility of administering a pca (patient controlled analgesia) bolus of 6 ml.
The Pump (CADD®-Solis Smiths medical) which will be started in the recovery room by an independent pain nurse or anaesthetist who is aware of the appointed study group (C group or B group). Pain scores ,motor block,sensory block and presence of numbness will be registered when the patient is awake enough to evaluate these parameters.
The patient will then be transferred to the ward after clear instructions of how to use the pain pump.The study will continue until 48 hours after starting the pump. Pain scores will be registered every four hours at the ward as well as feeling of numbness and sleep quality at regular intervals. During night hours (00-06)when the patient is sleeping pain scores will be registered as "S".When pain control is insufficient at the PACU or on the ward patients will receive paracetamol 1gr IV(Paracetamol® )and ketorolac (taradyal®) 30 mg IV. Tramadol ( contramal ®) 2 mg/kg will be given as rescue analgesia. On day one rescue analgesia will be provided orally .
All rescue analgesia or other medication will be registered.
48 hours after starting the pain pump the pump will be removed and all data will be collected and filed by an independent pain nurse or anaesthetist. This file will consist of a detailed description of the history of local anaesthetic administered, including total anaesthetic dose at 6,12,24 and 48 hours , frequency of extra boluses required and time intervals.
Before removing the nerve catheter the depth of the catheter is checked and bolus of nacl will be infused under ultrasound guidance and if possible correct placement can be confirmed after two days. Then the catheter will be removed.
After stopping the pump the patient will be asked if he or she was satisfied by the postoperative analgesic technique:
- Satisfied
- Sufficient
- Not satisfied
The patient is discharged but is asked to register the exact time point when sensation and motor function (when a motor block was present) after catheter removal appeared. The patient will be called two days after discharge to register these parameters.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C group | Experimental | Drug: continuous infusion of levobupivacainecontinuous infusion of levobupivacaine |
| B group | Experimental | Drug: Intermittent bolus infusion of levobupivacaineIntermittent bolus infusion of levobupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled for for surgery for hallux valgus pathology with general anesthesia and a popliteal nerve catheter (=sciatic nerve block)
Key exclusion criteria (6 listed)
- neuromuscular disease,
- chronic pain,
- peripheral neuropathy in lower limb,
- contraindication for popliteal nerve block,
- unable to use pca (patient controlled 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 |
|---|---|---|
| continuous infusion of levobupivacaineAlso: chirocainecontinuous infusion of levobupivacaine 0,125% at 5 ml/h , bolus dose 6 ml, lock out 30 minutes 4 hours limit: 60 ml/h | Drug | C group |
| Intermittent bolus infusion of levobupivacaineAlso: chirocaineIntermittent bolus of levobupivacaine 0,125%: 0.1 ml /h and 9,8 ml bolus every two hours. Optional patient controlled bolus dose 6 ml, lock out 30 minutes, 4 hours limit: 60 ml/h | Drug | B group |
Primary outcome
local anesthetic dose in 48 hours
Time frame: 48 hours
the total amount of local anesthetic dose (mg) in total administered by the pump connected to the sciatic nerve catheter from start of the pump until stop ( 48 hours after start)
5 secondary outcomes
pains scores
Time frame: 48 hours
motor block (possibility of tow movement ( yes/no)
Time frame: 48 hours
sensory block loss of cold sensation (yes/no)
Time frame: 48 hours
numbness (sensation of numbness (0 = no, 1= yes but not disturbing, 2= yes and disturbing)
Time frame: 48 hours
patient satisfaction 9satisfaction on a 10 point scal ( 0= very dissatisfied, 10 = very satisfied)
Time frame: 48 hours
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 23 Nov 2016.
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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.
Margaretha Breebaart principal investigator
University Hospital, Antwerp
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 continuous infusion of levobupivacaine and Intermittent bolus infusion of levobupivacaine in people with Hallux Valgus and Surgery, run by University Hospital, Antwerp at 1 site in Belgium.
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 6 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 23 Nov 2016. 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 Belgium. 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?
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?
local anesthetic dose in 48 hours (time frame: 48 hours). 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 23 Nov 2016.