Foot FracturePhase 4TramIschNCT03477851
Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis
A Phase 4 study testing Tramadol Hydrochloride in people with Foot Fracture and Pain, Acute, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Comparison of duration of efficient analgesia after painful surgical repair od foot fractures between groups treated with sciatic nerve block alone and sciatic nerve block simultaneously with i.m. tramadol Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Fracture, Pain, Acute
- What is being tested?
- Tramadol Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jun 2017to 30 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with foot fracture scheduled for surgical repair in spinal anesthesia
- Informed consent
Who cannot join
- No consent
- Spinal anesthesia or sciatic nerve block contraindicated
- Known intolerance to tramadol or other contraindications for the drug
Trial locations and contacts
1 site in 1 country.
Poland1 site
Dept.of Anesthesia and Intensive Care, Warsaw Medical University
Warsaw, Masovian Voivodeship, 02-005
About this study
Official title: Evaluation of the Influence of Tramadol Injection Simultaneous With Sciatic Nerve Block on the Duration of Efficient Sensory Blockade in Patients Operated on for Calcaneus Fracture
Comparison of duration of efficient analgesia after painful surgical repair od foot fractures between groups treated with sciatic nerve block alone and sciatic nerve block simultaneously with i.m. tramadol
Read the detailed description
A randomized, double-blinded study in patients scheduled for surgical repair of foot fractures in spinal anaesthesia where two pain treatment modalities would be compared. One group receives sciatic nerve block with standardized dosis od bupivacaine under ultrasound visualisation, while the other group receives the same block but with simultaneous i.m. injection of tramadol (also standardized). Both the patient and the anaesthesist are blinded, i.e. the control group receives simultaneously with the block a 0,9% sodium hydrochloride injected. Drug or control syringes do not differ, and would be prepared directly before in a randomised, blinded manner by trained co-investigator. Both group receive also the same standardised systemic analgetics with no further use of tramadol.
- Conditions
- Foot Fracture, Pain, Acute
- Being tested
- Tramadol Hydrochloride, Placebo
- Keywords
- sciatic nerve block, tramadol, foot fracture
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HydrochlorideDrug
Also called Tramadol i.m.
Tramadol i.m. simultaneous with sciatic nerve block
PlaceboDrug
Also called 0,9%NaCl i.m.
0,9%NaCl i.m. simultaneous with sciatic nerve block
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients randomized to receive 0,9% sodium hydrochloride solution 5ml i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block. Receives: Drug: Placebo |
| Tramadol | Experimental | Patients randomized to receive 100mg of Tramadol hydrochloride in 5ml 0,9% sodium hydrochloride i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block. Receives: Drug: Tramadol Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall analgesic in 24h
Overall Morphine hydrochloride dose in the first 24h after intervention
Measured: 24hour
Secondary outcomes (2)
Time to block resolution
Time from the intervention to complete motoric block resolution
Measured: 24hour
Time to first analgesic
Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride
Measured: 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start15 Jun 2017
- Primary completion30 Jun 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot FractureStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blinded two-arm parallel assignment
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janusz Trzebicki, Dr hab., Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477851
- Sponsor's protocol ID
- WNOZA/1/2017
- Acronym
- TramIsch
- Status last verified
- May 2020
- First submitted
- 19 Mar 2018
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Tramadol Injection Simultaneous With Sciatic Nerve Block on the Duration of Efficient Sensory Blockade in Patients Operated on for Calcaneus Fracture
- ClinicalTrials.gov ID
- NCT03477851
- Acronym / sponsor ID
- TramIsch / WNOZA/1/2017
- Conditions
- Foot Fracture, Pain, Acute
- Keywords
- sciatic nerve block, tramadol, foot fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 26 Mar 2018 (actual)
- 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.
Comparison of duration of efficient analgesia after painful surgical repair od foot fractures between groups treated with sciatic nerve block alone and sciatic nerve block simultaneously with i.m. tramadol
Detailed description
A randomized, double-blinded study in patients scheduled for surgical repair of foot fractures in spinal anaesthesia where two pain treatment modalities would be compared. One group receives sciatic nerve block with standardized dosis od bupivacaine under ultrasound visualisation, while the other group receives the same block but with simultaneous i.m. injection of tramadol (also standardized). Both the patient and the anaesthesist are blinded, i.e. the control group receives simultaneously with the block a 0,9% sodium hydrochloride injected. Drug or control syringes do not differ, and would be prepared directly before in a randomised, blinded manner by trained co-investigator. Both group receive also the same standardised systemic analgetics with no further use of tramadol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized, double blinded two-arm parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients randomized to receive 0,9% sodium hydrochloride solution 5ml i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block. |
| Tramadol | Experimental | Drug: Tramadol HydrochloridePatients randomized to receive 100mg of Tramadol hydrochloride in 5ml 0,9% sodium hydrochloride i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the 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 (2 listed)
- Patients with foot fracture scheduled for surgical repair in spinal anesthesia
- Informed consent
Key exclusion criteria (3 listed)
- No consent
- Spinal anesthesia or sciatic nerve block contraindicated
- Known intolerance to tramadol or other contraindications for the drug
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 |
|---|---|---|
| Tramadol HydrochlorideAlso: Tramadol i.m.Tramadol i.m. simultaneous with sciatic nerve block | Drug | Tramadol |
| PlaceboAlso: 0,9%NaCl i.m.0,9%NaCl i.m. simultaneous with sciatic nerve block | Drug | Placebo |
Primary outcome
Overall analgesic in 24h
Time frame: 24hour
Overall Morphine hydrochloride dose in the first 24h after intervention
2 secondary outcomes
Time to block resolution
Time frame: 24hour
Time to first analgesic
Time frame: 24hour
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 28 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Janusz Trzebicki, Dr hab. study chair
Medical University of Warsaw
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 Tramadol Hydrochloride in people with Foot Fracture and Pain, Acute, run by Medical University of Warsaw at 1 site in Poland.
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 2 inclusion and 3 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 28 Oct 2021. 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 Poland. 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.
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?
Overall analgesic in 24h (time frame: 24hour). 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 28 Oct 2021.