Postoperative PainPhase 4NCT01837394
Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy
A Phase 4 study testing Block of the SN and ONP, Paracetamol and Morphine in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Jens Borglum Neimann at 1 site in Denmark.
Trial summary
In this study, we wish to investigate the effect of ultrasound (US) -guided block of the saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following ambulatory knee arthroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea and Vomiting, Postoperative Function Level
- What is being tested?
- Block of the SN and ONP, Paracetamol and Morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Sep 2013
- 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
- Planned ambulatory knee arthroscopy, except cruciate ligament surgery
- American Society of Anesthesiologists (ASA) class 1-3
Who cannot join
- Cannot cooperate
- Do not speak or understand Danish
- Daily use of opioid analgesics
- Allergy towards any of the drugs used in the investigation
- Medicine abuse (at the investigators discretion)
- Alcohol abuse, as defined by the National Board of Health
- General anesthesia contraindicated, or the patient wants spinal anesthesia
- Visualization of necessary structures by ultrasound not possible, or block not possible for other technical reasons
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesiology, Bispebjerg Hospital
Copenhagen, 2400
About this study
Official title: Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy
In this study, we wish to investigate the effect of ultrasound (US) -guided block of the saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following ambulatory knee arthroscopy.
We wish to investigate the analgesic effect of these two blocks compared to placebo (injection of local anesthetic with known pain blocking properties compared with injection of a saline solution), when used as a supplement to conventional oral analgesics.
We hypothesize that patients receiving the active treatment may experience less pain during the first 24 hours after their operation than patients receiving the placebo treatment, and possibly require less opioid analgesics, experience less opioid related side effects and have a higher function level in this period than patients receiving the placebo treatment.
- Being tested
- Block of the SN and ONP, Placebo block, Paracetamol, Morphine, Ondansetron
- Keywords
- Nerve block, Ultrasound, postoperative pain, Saphenous nerve, Obturator nerve
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Block of the SN and ONPProcedure or surgery
Also called Naropin
7.5 ml of Ropivacaine 7.5 mg/ml injected at each site
Placebo blockProcedure or surgery
Also called NaCl
7.5 ml of isotonic saline solution 154 mmol/l injected at each site
ParacetamolDrug
Also called Acetaminophen
MorphineDrug
5 mg as needed
OndansetronDrug
Also called Zofran
4 mg i.v. as needed in the PACU
MetoclopramideDrug
Also called Emperal, Primperan
10 mg tablet as needed in the postoperative period after discharge from the PACU
| Study group | Role | What they receive |
|---|---|---|
| Block arm | Active comparator | Ultrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea. Receives: Procedure: Block of the SN and ONP; Drug: Paracetamol; Drug: Morphine; Drug: Ondansetron; Drug: Metoclopramide |
| Placebo arm | Placebo comparator | Ultrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea. Receives: Procedure: Placebo block; Drug: Paracetamol; Drug: Morphine; Drug: Ondansetron; Drug: Metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on knee flexion
VRS (Verbal Rating Scale) score 0-10 on active flexion of the knee to 45 degrees, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.
Measured: 24 hours postoperatively
Secondary outcomes (9)
Pain at rest
VRS (verbal rating score) 0-10 at rest, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.
Measured: 24 hours postoperatively
Time to opioid intake
First time the patient needs to take supplementary opioids in the postoperative period
Measured: 24 hours postoperatively
Total opioid intake
Total dose of opioids taken in the first 24 hours postoperatively
Measured: 24 hours
Nausea
VRS score 0-10, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.
Measured: 24 hours postoperatively
Vomiting
Number of times the patient has vomited in the first 24 hours postoperatively.
Measured: 24 hours
Use of antiemetics
Total dose of antiemetics taken during the first 24 hours postoperatively
Measured: 24 hours
PACU length of stay
Total length of stay in the post anesthetic care unit (PACU) after the operation.
Measured: 24 hours
Function level: Barthel Index/100
Modified Barthel Index/100 score 24 hours after the operation.
Measured: 24 hours
Function level: Short form (SF) -8
Short form (SF) -8 questionnaire 24 hours postoperatively
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- Investigators
- Bo Westergaard, MD, Principal investigator, Department of Anesthesiology, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837394
- Sponsor's protocol ID
- H-2-2011-029
- Status last verified
- Nov 2013
- First submitted
- 15 Apr 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT01837394
- Acronym / sponsor ID
- H-2-2011-029
- Keywords
- Nerve block, Ultrasound, postoperative pain, Saphenous nerve, Obturator nerve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jens Borglum NeimannUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 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.
In this study, we wish to investigate the effect of ultrasound (US) -guided block of the saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following ambulatory knee arthroscopy.
We wish to investigate the analgesic effect of these two blocks compared to placebo (injection of local anesthetic with known pain blocking properties compared with injection of a saline solution), when used as a supplement to conventional oral analgesics.
We hypothesize that patients receiving the active treatment may experience less pain during the first 24 hours after their operation than patients receiving the placebo treatment, and possibly require less opioid analgesics, experience less opioid related side effects and have a higher function level in this period than patients receiving the placebo treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block arm | Active comparator | Procedure: Block of the SN and ONP, Drug: Paracetamol, Drug: Morphine, Drug: Ondansetron, Drug: MetoclopramideUltrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea. |
| Placebo arm | Placebo comparator | Procedure: Placebo block, Drug: Paracetamol, Drug: Morphine, Drug: Ondansetron, Drug: MetoclopramideUltrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned ambulatory knee arthroscopy, except cruciate ligament surgery
- American Society of Anesthesiologists (ASA) class 1-3
Key exclusion criteria (8 listed)
- Cannot cooperate
- Do not speak or understand Danish
- Daily use of opioid analgesics
- Allergy towards any of the drugs used in the investigation
- Medicine abuse (at the investigators discretion)
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 |
|---|---|---|
| Block of the SN and ONPAlso: Naropin7.5 ml of Ropivacaine 7.5 mg/ml injected at each site | Procedure or surgery | Block arm |
| Placebo blockAlso: NaCl7.5 ml of isotonic saline solution 154 mmol/l injected at each site | Procedure or surgery | Placebo arm |
| ParacetamolAlso: Acetaminophen | Drug | Block arm, Placebo arm |
| Morphine5 mg as needed | Drug | Block arm, Placebo arm |
| OndansetronAlso: Zofran4 mg i.v. as needed in the PACU | Drug | Block arm, Placebo arm |
| MetoclopramideAlso: Emperal, Primperan10 mg tablet as needed in the postoperative period after discharge from the PACU | Drug | Block arm, Placebo arm |
Primary outcome
Pain on knee flexion
Time frame: 24 hours postoperatively
VRS (Verbal Rating Scale) score 0-10 on active flexion of the knee to 45 degrees, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.
9 secondary outcomes
Pain at rest
Time frame: 24 hours postoperatively
Time to opioid intake
Time frame: 24 hours postoperatively
Total opioid intake
Time frame: 24 hours
Nausea
Time frame: 24 hours postoperatively
Vomiting
Time frame: 24 hours
Use of antiemetics
Time frame: 24 hours
PACU length of stay
Time frame: 24 hours
Function level: Barthel Index/100
Time frame: 24 hours
Function level: Short form (SF) -8
Time frame: 24 hours
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 6 Nov 2013.
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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.
Bo Westergaard, MD principal investigator
Department of Anesthesiology, Bispebjerg Hospital
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 Block of the SN and ONP, Paracetamol and Morphine in people with Postoperative Pain and Postoperative Nausea and Vomiting, 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 2 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 6 Nov 2013. 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.
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?
Pain on knee flexion (time frame: 24 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 6 Nov 2013.