Surgical WoundNCT05693454
Local Wound Anesthesia in Spine Surgery
A study testing Infiltration with NaCl, Infiltration with Ropivacain and Infiltration with a combination of Levobupivacaine and Tramadol in people with Surgical Wound and Orthopedic Disorder of Spine, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
Prospective, randomized, double-blinded, trial regarding the effect of local wound infiltration at the end of spine surgery; randomizing 1:1:1 between NaCl, Ropivacain, Levobupivacaine combined with Tramadol Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Orthopedic Disorder of Spine
- What is being tested?
- Infiltration with NaCl, Infiltration with Ropivacain and Infiltration with a combination of Levobupivacaine and Tramadol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2021to 31 Mar 2023
- 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
- Informed Consent
- Age ≥ 18 years
- Elective spine surgery with any technique
- At least 6 weeks of scheduled follow-up from hospitalization
Who cannot join
- Documented decline for data inclusion
- Allergy to any of the drugs used
- <50kg total body weight
- Vertebro- or Kyphoplasty
- Pregnancy and breast feeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Wound Anesthesia in Spine Surgery - a Randomized Double Blind Controlled Trial
Prospective, randomized, double-blinded, trial regarding the effect of local wound infiltration at the end of spine surgery; randomizing 1:1:1 between NaCl, Ropivacain, Levobupivacaine combined with Tramadol
Read the detailed description
Subcutaneous local wound injections with NaCl, Ropivacain or Levobupivacaine combined with Tramadol will be performed in a randomized, double-blinded manner at the end of spine surgery. Pain control, dosage of analgesics used, analgesics reduction compared to preoperative, wound healing problems and clinical outcome socres will be assessed up to 6 weeks after surgery
- Conditions
- Surgical Wound, Orthopedic Disorder of Spine
- Being tested
- Infiltration with NaCl, Infiltration with Ropivacain, Infiltration with a combination of Levobupivacaine and Tramadol
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiltration with NaClDrug
Local wound infiltration at the end of spine surgery with NaCl
Infiltration with RopivacainDrug
Local wound infiltration at the end of spine surgery with Ropivacain
Infiltration with a combination of Levobupivacaine and TramadolDrug
Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | local wound infiltration at the end of spine surgery with NaCl Receives: Drug: Infiltration with NaCl |
| Arm I | Active comparator | local wound infiltration at the end of spine surgery with Ropivacain Receives: Drug: Infiltration with Ropivacain |
| Arm II | Active comparator | local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol Receives: Drug: Infiltration with a combination of Levobupivacaine and Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Measured: 2 hours after surgery
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Measured: 4 hours after surgery
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Measured: 8 hours after surgery
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Measured: 12 hours after surgery
Pain control
analgesics consumption
Measured: until 42 days after surgery
Secondary outcomes (6)
costs
total costs for the intervention under study in Swiss Francs
Measured: at 42 days after surgery
sick leave
duration of sick leave
Measured: at 42 days after surgery
hospital stay
length of hospital stay in days
Measured: up to 8 weeks
wound drying
time in days until wound is dry
Measured: up to 8 weeks
wound length
wound length
Measured: up to 8 weeks
wound healing
have wound healing problems occurred (yes / no)
Measured: until 42 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Nov 2021
- Primary completion31 Jan 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double blind, controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mazda Farshad, Prof, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693454
- Sponsor's protocol ID
- LAWS
- Status last verified
- Jun 2023
- First submitted
- 20 Jul 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers outside of our institution
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Wound Anesthesia in Spine Surgery - a Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT05693454
- Acronym / sponsor ID
- LAWS
- Conditions
- Surgical Wound, Orthopedic Disorder of Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 23 Jan 2023 (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.
Prospective, randomized, double-blinded, trial regarding the effect of local wound infiltration at the end of spine surgery; randomizing 1:1:1 between NaCl, Ropivacain, Levobupivacaine combined with Tramadol
Detailed description
Subcutaneous local wound injections with NaCl, Ropivacain or Levobupivacaine combined with Tramadol will be performed in a randomized, double-blinded manner at the end of spine surgery. Pain control, dosage of analgesics used, analgesics reduction compared to preoperative, wound healing problems and clinical outcome socres will be assessed up to 6 weeks after surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- randomized, double blind, controlled
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Infiltration with NaCllocal wound infiltration at the end of spine surgery with NaCl |
| Arm I | Active comparator | Drug: Infiltration with Ropivacainlocal wound infiltration at the end of spine surgery with Ropivacain |
| Arm II | Active comparator | Drug: Infiltration with a combination of Levobupivacaine and Tramadollocal wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent
- Age ≥ 18 years
- Elective spine surgery with any technique
- At least 6 weeks of scheduled follow-up from hospitalization
Key exclusion criteria (6 listed)
- Documented decline for data inclusion
- Allergy to any of the drugs used
- <50kg total body weight
- Vertebro- or Kyphoplasty
- Pregnancy and breast feeding
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 |
|---|---|---|
| Infiltration with NaClLocal wound infiltration at the end of spine surgery with NaCl | Drug | Control |
| Infiltration with RopivacainLocal wound infiltration at the end of spine surgery with Ropivacain | Drug | Arm I |
| Infiltration with a combination of Levobupivacaine and TramadolLocal wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol | Drug | Arm II |
Primary outcome
Pain control
Time frame: 2 hours after surgery
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control
Time frame: 4 hours after surgery
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control
Time frame: 8 hours after surgery
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control
Time frame: 12 hours after surgery
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control
Time frame: until 42 days after surgery
analgesics consumption
6 secondary outcomes
costs
Time frame: at 42 days after surgery
sick leave
Time frame: at 42 days after surgery
hospital stay
Time frame: up to 8 weeks
wound drying
Time frame: up to 8 weeks
wound length
Time frame: up to 8 weeks
wound healing
Time frame: until 42 days after surgery
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 Jun 2023.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers outside of our institution
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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.
Mazda Farshad, Prof principal investigator
Balgrist 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 Infiltration with NaCl, Infiltration with Ropivacain and Infiltration with a combination of Levobupivacaine and Tramadol in people with Surgical Wound and Orthopedic Disorder of Spine, run by Balgrist University Hospital at 1 site in Switzerland.
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 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 28 Jun 2023. 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 Switzerland. 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 control (time frame: 2 hours after surgery). The study lists 5 primary outcomes in all. 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 Jun 2023.