Anterior Cruciate Ligament InjuriesDUALNCT05532618
Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery
A study testing Adductor canal block and Levobupivacaine in people with Anterior Cruciate Ligament Injuries, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Adductor canal block and Levobupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2022to 1 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Undergoing anterior cruciate ligament surgery under general anesthesia
- ASA I-III
Who cannot join
- Contraindication for locoregional anesthesia; infection at the target puncture site, allergy to local anesthetics,
- Neuromuscular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery: A Prospective Double Blinded Randomized Controlled Trial
The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery
Read the detailed description
Patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent.
Before surgery, patients will receive an adductor canal bock with Levobupivacaine (intervention group) or 0.9% saline (control group).
Following surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Adductor canal block, Levobupivacaine, Placebo
- Keywords
- adductor canal block
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal blockProcedure or surgery
Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.
LevobupivacaineDrug
Levobupivacaine
PlaceboDrug
10 ml of sodium chloride 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine | Active comparator | Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound Receives: Procedure: Adductor canal block; Drug: Levobupivacaine |
| Placebo | Placebo comparator | Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound Receives: Procedure: Adductor canal block; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain level
Using Numerical Rating Scales for pain from 1 to 10, 1 is no pain, 10 is the worst pain you can imagine
Measured: Within first 48 hours after surgery
Secondary outcomes (4)
Opiate use
postoperative use of opiates (Morphine equivalent dose (mg))
Measured: Within first 48 hours after surgery
Nausea
Postoperative nausea (yes/no)
Measured: Within first 48 hours after surgery
Block result
If there's any loss of motor function (no quadriceps paresis, partial quadriceps paresis, complete quadriceps paresis.) using bromage score
Measured: within first 24 hours after surgery
Patient satisfaction
Using Numerical Rating Scales from 1 to 10, 1 is not satisfied at all, 10 is completely satisfied
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies 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
- Patients are randomized to receive an intervention (nerve block) with either an active drug or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon Timmerman, St. Antonius Hospital
- Investigators
- Leon Timmerman, dr, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532618
- Sponsor's protocol ID
- NL 81489.100.22
- Acronym
- DUAL
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication of the results, anonymized IPD (all study results) will be available for meta-analyses upon request.
Publications
Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.
PubMed 23788068Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21.
PubMed 31980156
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery: A Prospective Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05532618
- Acronym / sponsor ID
- DUAL / NL 81489.100.22
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- adductor canal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 8 Sep 2022 (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.
The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery
Detailed description
Patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent.
Before surgery, patients will receive an adductor canal bock with Levobupivacaine (intervention group) or 0.9% saline (control group).
Following surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized to receive an intervention (nerve block) with either an active drug or placebo.
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine | Active comparator | Procedure: Adductor canal block, Drug: LevobupivacaineIntervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound |
| Placebo | Placebo comparator | Procedure: Adductor canal block, Drug: PlaceboControl group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Undergoing anterior cruciate ligament surgery under general anesthesia
- ASA I-III
Key exclusion criteria (2 listed)
- Contraindication for locoregional anesthesia; infection at the target puncture site, allergy to local anesthetics,
- Neuromuscular 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 |
|---|---|---|
| Adductor canal blockBefore anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound. | Procedure or surgery | Levobupivacaine, Placebo |
| LevobupivacaineLevobupivacaine | Drug | Levobupivacaine |
| Placebo10 ml of sodium chloride 0.9% | Drug | Placebo |
Primary outcome
Postoperative pain level
Time frame: Within first 48 hours after surgery
Using Numerical Rating Scales for pain from 1 to 10, 1 is no pain, 10 is the worst pain you can imagine
4 secondary outcomes
Opiate use
Time frame: Within first 48 hours after surgery
Nausea
Time frame: Within first 48 hours after surgery
Block result
Time frame: within first 24 hours after surgery
Patient satisfaction
Time frame: 48 hours 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 13 Sep 2023.
- Background: PubMed 23788068Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.
- Background: PubMed 31980156Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21.
- Individual participant dataSharing planned: Yes. Following publication of the results, anonymized IPD (all study results) will be available for meta-analyses upon request.
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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.
Leon Timmerman, dr principal investigator
St. Antonius 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 Adductor canal block and Levobupivacaine in people with Anterior Cruciate Ligament Injuries, run by St. Antonius Hospital at 1 site in Netherlands.
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 2 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 13 Sep 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 Netherlands. 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?
Postoperative pain level (time frame: Within first 48 hours after surgery). 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 NCT05532618, which also lists 2 linked publications.
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 13 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.