Nerve BlockNCT02436694
Nerve Blocks With Dexamethasone and Local Anaesthetic to Improve Postoperative Analgesia
A study testing Local Anesthetic ropivacaíne and Perineural Dexamethasone in people with Nerve Block, run by Centro Hospitalar do Porto at 1 site in Portugal.
Trial summary
Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and sciatic nerve block improve analgesia postoperatively in patients submitted to total knee arthroplasty? Primary aim: Evaluate the efficacy of the association of dexamethasone to the local anaesthetic in a SSFNB and SSSNB in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Block
- What is being tested?
- Local Anesthetic ropivacaíne and Perineural Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePortugal
- Study dates
- Apr 2015to Apr 2016
- 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
- Adult patients admitted foi unilaterla total knee arthroplasty
Who cannot join
- Refusal/Incapacity to give informed consent
- Contra-indication to general anesthesia
- Infection at needle insertion site
- Coagulation disorders
- Pre-existing neurologic disorders
- Known allergy to any of the drugs from the protocol
Show all 10Show fewer
- ASA status >3
- Weight<50kg
- BMI>40
- Inability to understand or use VAS pain score
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar do Porto
Porto, Porto District, 4099-001
Marta M Carvalho, MD, 00351912948973, marta.monteiro.carvalho@gmail.com
Silvia AB Pinho, MD, 00351914619787, silviaabpinho@gmail.com
About this study
Official title: Can the Association of Dexamethasone and Local Anaesthetic in a Single-shot Femoral and Sciatic Nerve Block Improve Analgesia Postoperatively in Patients Submitted to Total Knee Arthroplasty
Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and sciatic nerve block improve analgesia postoperatively in patients submitted to total knee arthroplasty? Primary aim: Evaluate the efficacy of the association of dexamethasone to the local anaesthetic in a SSFNB and SSSNB in reducing pain scores, assessed by VAS.
Outcome measures: Mean pain scores in both groups. Secondary aims: Evaluate opioid consumption in the postoperative period (8- 12h, 24h, 48h) and assess incidence of side effects and complications (numbness, paraesthesias, weakness, site infection, haematoma and falls).
Read the detailed description
All blocks are performed using nerve stimulation technique. For the SSFNB, the paravascular approach will be used to identify the femoral nerve.15 A positive location is considered when quadriceps contraction (patellar elevation) is elicited with a current of 0.4 mA or less, and 30mL of ropivacaine 0.375%, with or without 4mg of dexamethasone are injected, according to the randomization.
For the SSSNB the anterior approach will be chosen.16 The common peroneal or the tibial nerves are identified, respectively by dorsiflexion or plantar flexion of the foot, with a current of 0.4 mA or less. Depending on the allocated group, 20mL of ropivacaine 0.2%, with or without 4mg of dexamethasone are then injected. Blocks success should be assessed by the absence of thermal sensitivity on the anterior region of the thigh and the dorsum of the foot 10 minutes after the block.
The participating anaesthesiologists may use the ultrasound for visual guidance but should also use the nerve stimulator in order to maintain the homogeneity of the procedure.
Patients will then have an intravenous induction to general anesthesia, being the maintenance assured with either Desflurane or Sevoflurane. Thirty minutes before the end of the procedure all patients are given paracetamol 1000mg and ketorolac 30mg. Total doses of intraoperative analgesics are recorded.
Before surgery all patients will be explained how to use the PCA, which is connected after arrival to the post-anesthesia unit (PACU). The PCA is programmed for 1mg bolus as required by the patient, with a lockout period of 7 minutes. In what concerns the remaining post-operative analgesia, both groups are prescribed paracetamol 1000mg q8h, diclofenac 50mg q12h, and as rescue strategy, tramadol 100mg q6h.
The demographic data as well as the information of the anesthetic form is recorded in an excel table. After surgery, at 8-12h, 24h and 48h (+/-2h) pain is evaluated using a standard 100mm VAS. Consumption of morphine and other rescue analgesia is recorded in the same time periods, as well as the complications and side-effects previously determined.
The primary outcome is pain assessed by VAS (1-100mm - continuous variable), measured ate 8-12h, 24h and 48h. Difference in mean values for both groups will be measured. Morphine consumption is measured in milligrams, and the mean consumption of both groups is analysed. Side-effects and complications will be reported and their incidence calculated.
- Conditions
- Nerve Block
- Being tested
- Local Anesthetic ropivacaíne, Perineural Dexamethasone
- Keywords
- Dexamethasone, Perineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anesthetic ropivacaíneDrug
Also called Nerve block with local anesthetic
Femoral and sciatic nerve block with ropivacaíne
Perineural DexamethasoneDrug
Also called Nerve block with local anesthetic and dexamethasone
Addition of perineural dexamethasone to local anesthetic for femoral and sciatic nerve block
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthetic ropivacaíne | Active comparator | Femoral nerve block with ropivacaine 0.375% and sciatic nerve block with ropivacaine 0.2% Receives: Drug: Local Anesthetic ropivacaíne |
| Perineural Dexamethasone | Experimental | Femoral nerve block with ropivacaine 0.375% and perineural dexamethasone and sciatic nerve block with ropivacaine 0.2% and perineural dexamethasone Receives: Drug: Local Anesthetic ropivacaíne; Drug: Perineural Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Pain by VAS
Pain assessed by VAS
Measured: 48 hours
Secondary outcomes (3)
Morphine consumption in mg
Morphine consumption in PCA measured in mg
Measured: 48 hours
Side-effects (numbness, paraesthesias, weakness, site infection, haematoma and falls)
Measured: 48 hours
Complications from technique (Motor ou sensitive changes, infection, nausea)
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 posted7 May 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Carvalho, Centro Hospitalar do Porto
- Investigators
- Raul carvalho, MD, Study director, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436694
- Sponsor's protocol ID
- 2014.236(174-DEFI/199-CES)
- Status last verified
- Nov 2015
- First submitted
- 1 Apr 2015
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Association of Dexamethasone and Local Anaesthetic in a Single-shot Femoral and Sciatic Nerve Block Improve Analgesia Postoperatively in Patients Submitted to Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02436694
- Acronym / sponsor ID
- 2014.236(174-DEFI/199-CES)
- Conditions
- Nerve Block
- Keywords
- Dexamethasone, Perineural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Centro Hospitalar do PortoUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 7 May 2015 (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.
Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and sciatic nerve block improve analgesia postoperatively in patients submitted to total knee arthroplasty? Primary aim: Evaluate the efficacy of the association of dexamethasone to the local anaesthetic in a SSFNB and SSSNB in reducing pain scores, assessed by VAS.
Outcome measures: Mean pain scores in both groups. Secondary aims: Evaluate opioid consumption in the postoperative period (8- 12h, 24h, 48h) and assess incidence of side effects and complications (numbness, paraesthesias, weakness, site infection, haematoma and falls).
Detailed description
All blocks are performed using nerve stimulation technique. For the SSFNB, the paravascular approach will be used to identify the femoral nerve.15 A positive location is considered when quadriceps contraction (patellar elevation) is elicited with a current of 0.4 mA or less, and 30mL of ropivacaine 0.375%, with or without 4mg of dexamethasone are injected, according to the randomization.
For the SSSNB the anterior approach will be chosen.16 The common peroneal or the tibial nerves are identified, respectively by dorsiflexion or plantar flexion of the foot, with a current of 0.4 mA or less. Depending on the allocated group, 20mL of ropivacaine 0.2%, with or without 4mg of dexamethasone are then injected. Blocks success should be assessed by the absence of thermal sensitivity on the anterior region of the thigh and the dorsum of the foot 10 minutes after the block.
The participating anaesthesiologists may use the ultrasound for visual guidance but should also use the nerve stimulator in order to maintain the homogeneity of the procedure.
Patients will then have an intravenous induction to general anesthesia, being the maintenance assured with either Desflurane or Sevoflurane. Thirty minutes before the end of the procedure all patients are given paracetamol 1000mg and ketorolac 30mg. Total doses of intraoperative analgesics are recorded.
Before surgery all patients will be explained how to use the PCA, which is connected after arrival to the post-anesthesia unit (PACU). The PCA is programmed for 1mg bolus as required by the patient, with a lockout period of 7 minutes. In what concerns the remaining post-operative analgesia, both groups are prescribed paracetamol 1000mg q8h, diclofenac 50mg q12h, and as rescue strategy, tramadol 100mg q6h.
The demographic data as well as the information of the anesthetic form is recorded in an excel table. After surgery, at 8-12h, 24h and 48h (+/-2h) pain is evaluated using a standard 100mm VAS. Consumption of morphine and other rescue analgesia is recorded in the same time periods, as well as the complications and side-effects previously determined.
The primary outcome is pain assessed by VAS (1-100mm - continuous variable), measured ate 8-12h, 24h and 48h. Difference in mean values for both groups will be measured. Morphine consumption is measured in milligrams, and the mean consumption of both groups is analysed. Side-effects and complications will be reported and their incidence calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Anesthetic ropivacaíne | Active comparator | Drug: Local Anesthetic ropivacaíneFemoral nerve block with ropivacaine 0.375% and sciatic nerve block with ropivacaine 0.2% |
| Perineural Dexamethasone | Experimental | Drug: Local Anesthetic ropivacaíne, Drug: Perineural DexamethasoneFemoral nerve block with ropivacaine 0.375% and perineural dexamethasone and sciatic nerve block with ropivacaine 0.2% and perineural dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients admitted foi unilaterla total knee arthroplasty
Key exclusion criteria (10 listed)
- Refusal/Incapacity to give informed consent
- Contra-indication to general anesthesia
- Infection at needle insertion site
- Coagulation disorders
- Pre-existing neurologic disorders
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 |
|---|---|---|
| Local Anesthetic ropivacaíneAlso: Nerve block with local anestheticFemoral and sciatic nerve block with ropivacaíne | Drug | Local Anesthetic ropivacaíne, Perineural Dexamethasone |
| Perineural DexamethasoneAlso: Nerve block with local anesthetic and dexamethasoneAddition of perineural dexamethasone to local anesthetic for femoral and sciatic nerve block | Drug | Perineural Dexamethasone |
Primary outcome
Quantification of Pain by VAS
Time frame: 48 hours
Pain assessed by VAS
3 secondary outcomes
Morphine consumption in mg
Time frame: 48 hours
Side-effects (numbness, paraesthesias, weakness, site infection, haematoma and falls)
Time frame: 48 hours
Complications from technique (Motor ou sensitive changes, infection, nausea)
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 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.
Raul carvalho, MD study director
Centro Hospitalar do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Anesthetic ropivacaíne and Perineural Dexamethasone in people with Nerve Block, run by Centro Hospitalar do Porto at 1 site in Portugal.
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 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: status not confirmed, as of the sponsor's last update on 26 Nov 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta M Carvalho, MD (00351 912948973, marta.monteiro.carvalho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of Pain by VAS (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 26 Nov 2015.