Pain, PostoperativeNCT01840800
USG Nerve Blocks for ACL Reconstruction
A study testing Ropivacaine in people with Pain, Postoperative, run by Jens Borglum Neimann at 1 site in Denmark.
Trial summary
Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional femoral/sciatic block combinations effectively reduce postoperative pain, but results in considerable motor blockade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Jun 2014
- 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
- Age ≥ 18 years.
- Isolated primary ACL reconstruction in general anaesthesia with hamstring graft.
- ASA 1-3.
- Written and informed consent to study protocol.
Who cannot join
- ACL reconstruction with patellar tendon graft
- Uncooperative patients.
- Patients that do not understand or speak danish.
- Daily use of opioids equivalent to > 40 mg morphine.
- Allergic to Ropivacaine.
- Alcohol abusers
- Contraindications to general anaesthesia.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, department of anesthesiology
Copenhagen, 2400
About this study
Official title: Ultrasound Guided Nerve Block Combinations for Anterior Cruciate Ligament Reconstruction; Femoral, Saphenous and Obturator (Posterior Branch)Nerves.
Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional femoral/sciatic block combinations effectively reduce postoperative pain, but results in considerable motor blockade. The investigators aimed to evaluate postoperative pain relief and the degree of motor block with block combinations of femoral nerve (FEM) and obturator [posterior branch] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks with isotonic saline. All patients received standard patient controlled analgesia with morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB approval, 81 patients were planned to be randomized to one of three USG block combinations: Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used for all active blocks following induction of general anaesthesia [propofol-remifentanil, laryngeal mask airway]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours postoperatively at rest.
Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time, motor abilities of daily living scores [modified Barthel/100 index], perceived ill health [Short form-8] scores and degree of motor blockade [Jensen- Børglum motor test].
- Conditions
- Pain, Postoperative
- Being tested
- Ropivacaine, placebo
- Keywords
- Postoperative pain, anterior cruciate ligament reconstruction, ultrasound guided nerve blocks, opioid consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Active FEM+ONP | Active comparator | Nerveblock of n. femoralis (FEM) with 10 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerveposterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml. Receives: Drug: Ropivacaine |
| Active SAPH+ONP | Active comparator | Nerveblock of n.saphenous (SAPH) with 5 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerve, posterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml Receives: Drug: Ropivacaine |
| Placebo | Placebo comparator | Saline 9 mg/ml Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (pain score)
Numerical rating scale(0-10)
Measured: Area under the curve (AUC) 0-6 hours postoperatively
Secondary outcomes (6)
Opioid consumption
Opioid consumption (PCA pump - mg of morphine)
Measured: 0-6 hours postoperatively
opioid related side effects
Nausea (0-3), vomiting (>10 ml)
Measured: 0-6 hours postoperatively
PACU time
Minutes in PACU
Measured: 0-6 hours postoperatively
Motor abilities of of daily living
Modified Barthel/100 index
Measured: 0-24 hours postoperatively
Perceived ill health
Short-Form-8
Measured: 0-24 hours postoperatively
Degree of motor block.
Jensen-Borglum motor test
Measured: 0-6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Borglum Neimann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Borglum Neimann, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840800
- Sponsor's protocol ID
- H-2-2012-063
- Status last verified
- Jul 2014
- First submitted
- 19 Feb 2013
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Nerve Block Combinations for Anterior Cruciate Ligament Reconstruction; Femoral, Saphenous and Obturator (Posterior Branch)Nerves.
- ClinicalTrials.gov ID
- NCT01840800
- Acronym / sponsor ID
- H-2-2012-063
- Conditions
- Pain, Postoperative
- Keywords
- Postoperative pain, anterior cruciate ligament reconstruction, ultrasound guided nerve blocks, opioid consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Jens Borglum NeimannUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Apr 2013 (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.
Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional femoral/sciatic block combinations effectively reduce postoperative pain, but results in considerable motor blockade. The investigators aimed to evaluate postoperative pain relief and the degree of motor block with block combinations of femoral nerve (FEM) and obturator [posterior branch] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks with isotonic saline. All patients received standard patient controlled analgesia with morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB approval, 81 patients were planned to be randomized to one of three USG block combinations: Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used for all active blocks following induction of general anaesthesia [propofol-remifentanil, laryngeal mask airway]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours postoperatively at rest.
Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time, motor abilities of daily living scores [modified Barthel/100 index], perceived ill health [Short form-8] scores and degree of motor blockade [Jensen- Børglum motor test].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active FEM+ONP | Active comparator | Drug: RopivacaineNerveblock of n. femoralis (FEM) with 10 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerveposterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml. |
| Active SAPH+ONP | Active comparator | Drug: RopivacaineNerveblock of n.saphenous (SAPH) with 5 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerve, posterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml |
| Placebo | Placebo comparator | Drug: placeboSaline 9 mg/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Isolated primary ACL reconstruction in general anaesthesia with hamstring graft.
- ASA 1-3.
- Written and informed consent to study protocol.
Key exclusion criteria (8 listed)
- ACL reconstruction with patellar tendon graft
- Uncooperative patients.
- Patients that do not understand or speak danish.
- Daily use of opioids equivalent to > 40 mg morphine.
- Allergic to Ropivacaine.
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 |
|---|---|---|
| Ropivacaine | Drug | Active FEM+ONP, Active SAPH+ONP |
| placebo | Drug | Placebo |
Primary outcome
NRS (pain score)
Time frame: Area under the curve (AUC) 0-6 hours postoperatively
Numerical rating scale(0-10)
6 secondary outcomes
Opioid consumption
Time frame: 0-6 hours postoperatively
opioid related side effects
Time frame: 0-6 hours postoperatively
PACU time
Time frame: 0-6 hours postoperatively
Motor abilities of of daily living
Time frame: 0-24 hours postoperatively
Perceived ill health
Time frame: 0-24 hours postoperatively
Degree of motor block.
Time frame: 0-6 hours postoperatively
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 31 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Pain, Postoperative, run by Jens Borglum Neimann at 1 site in Denmark.
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 8 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 31 Jul 2014. 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 Denmark. 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?
NRS (pain score) (time frame: Area under the curve (AUC) 0-6 hours postoperatively). 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 31 Jul 2014.