Postoperative PainNCT03990038
Comparison of Two Multimodal Analgesia Regimens in Total Knee Arthroplasty
A study testing Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 h and Extended Release Capsule in people with Postoperative Pain, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
The improvement of postoperative analgesia is an important issue in orthopedic surgery, especially after total knee arthroplasty The use of a peripheral nerve block such as the adductor canal block is favored since it offers a postoperative analgesia superior to opioids, and also preserves the strength of the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 h and Extended Release Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to 1 Oct 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years old
- American Society of Anesthesiology physical status I-III
- Primary total knee arthroplasty surgery under regional anesthesia
Who cannot join
- Chronic kidney disease (CKD) with eGFR < 60mL/min
- Contraindications for the use of spinal anesthesia or adductor canal block : infection, sepsis, evolutive neurological disease, coagulopathy, patient refusal.
- Chronic use of opioids (>30 mg daily morphine equivalent)
- Documented allergy to Hydromorphone, tramadol, celecoxib, ropivacaine, pregabalin, acetaminophen and/or ketorolac
- Patient weight < 50 kg or BMI > 40
- Severe cardiac disease
Show all 11Show fewer
- Severe pulmonary disease
- Chronic use of monoamine oxydase inhibitors
- Pregnancy
- Inability to give informed consent
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Multimodal Analgesia Regimens for Total Knee Arthroplasty : a Randomized Controlled Trial
The improvement of postoperative analgesia is an important issue in orthopedic surgery, especially after total knee arthroplasty The use of a peripheral nerve block such as the adductor canal block is favored since it offers a postoperative analgesia superior to opioids, and also preserves the strength of the quadriceps, as opposed to the femoral block.
The adductor canal block can be given as a single injection (single shot) or a continuous perineural infusion to extend the block's analgesic duration. It is unclear if the continuous infusion is superior to the single shot. Indeed, a high catheter dislodgement rate is observed for this location and local anesthetics could migrate into the femoral canal, resulting in quadriceps weakness. Alternatively, adequate postoperative analgesia has been shown effective with a single shot adductor canal block combined with extended release opioids.
Read more
The primary objective in this study is to compare two analgesic protocols on the pain score at walk 24 hours after total knee arthroplasty.
Here are the two protocols compared :
- Adductor canal block followed by continuous perineural perfusion for 48 hours
- Adductor canal block (single shot) followed by hydromorphone extended release formulation for 48 hours In addition to analgesic adjuvants administered in both groups : acetaminophen, celecoxib, pregabalin, dexamethasone and periarticular infiltration.
Our hypothesis is that both protocols ensure a similar analgesia.
Read the detailed description
The improvement of postoperative analgesia is an important issue in orthopedic surgery, especially after total knee arthroplasty. The early postoperative mobilization of these patients is crucial to ensure a favorable functional evolution, and this goal can't be accomplished without effective analgesia. Opioids offer an efficient pain relief, but their consumption can result in side effects that can increase the length of hospital stay. The use of a peripheral nerve block, such as the adductor canal block (BCA) is a widely favored alternative since it allows postoperative analgesia superior to opioids while preserving the strength of the quadriceps.
For a long period of time, the femoral block has been the most popular peripheral nerve block for patients after a knee arthroplasty. However, this perineural block is associated with an important rate of quadriceps' weakness, which could impair the post-operative mobilization and expose the patient to a risk of falling. It has now been widely replaced by the adductor canal block. The latter has the advantage of providing analgesia at rest and during movement equivalent to the femoral block, while preserving the quadriceps strength and offering a better mobility in the first 24 hours after surgery. In opposition to the femoral block, the adductor canal block does not increase the risk of falling since it is mainly a sensitive block.
The adductor canal block is an advantageous analgesic modality for patients after TKA, but it is limited since it offers only analgesia to the anteromedial aspect of the knee, sparing the lateral and posterior faces. It is common to combine this block with a periarticular knee infiltration with local anesthetics, performed by the surgical team at the end of the surgery. The two modalities combined make it possible to achieve very low pains scores at rest and during walking, compared to both techniques used separately.
The adductor canal block can be administered in one unique injection or with a perineural continuous infusion, to extend the block's analgesic duration. However, it is uncertain whether there is an advantage to use a continuous infusion. There is a significant rate of catheter migrating out of the adductor canal and losing effect. There is also the possibility that the continuous infusion results in a proximal extent of local anesthetic in the femoral canal, generating quadriceps weakness that invalidates the benefits for ACB in the context of postoperative mobilization.
Indeed, the location of the catheter near the surgical site predisposes it to be dislodged out of the adductor canal during surgical manipulations in a significant proportion of patients. A rate as high as 30% of catheter dislodgement on postoperative day 1 was observed. It is possible to perform the block after surgery, before the dressing is applied, but this practice tends to create delays, which are not desirable in the actual context of optimization of the OR time.
In addition, perineural catheters require a strict surveillance by a specialized team and could interfere with patient mobilization because of the restriction associated with the equipment involved. It is reasonable to think that the absence of a catheter and an infusion pump offers an easier mobilization, although this has not been validated in clinical trials.
Finally, continuous infusions increase the cumulative dose of local anesthetics that the patients is exposed to. In order to reduce the toxicity risk, it is necessary to reduce the periarticular infiltration doses, which could impair the quality of analgesia.
Alternatively, it has been demonstrated that adequate post-operative analgesia could be obtained with an adductor canal block, combined with extended release opioids. Several clinical trials involving patients after total knee arthroplasty have shown that there is a benefit to using extended release opioids added to a multimodal analgesia protocol. Their pharmacokinetic profile ensures a more constant analgesia, while offering a safety profile similar to immediate release opioids, a lesser risk of respiratory depression and overdose. The usage of extended release opioids after TKA is justified since patients accuse moderate to severe pain during the first days after surgery, despite the use of a multimodal analgesia protocol and sustained consumption of immediate release opioids.
These two protocols have not been compared.
In conclusion, there is a consensus that postoperative analgesia in patients after TKA should be addressed with a multimodal analgesia protocol that includes a perineural block and analgesic adjuvants. However, the optimal composition of this protocol is not well defined. In our hospital center, the postoperative analgesia protocol for TKA includes a continuous adductor canal block for 48 hours, intravenous dexamethasone, periarticular infiltration of the posterior capsule by the surgeon and analgesic adjuvants such as acetaminophen, celecoxib and pregabalin.
Study outcome and hypothesis
The primary objective in this study is to compare two analgesic protocols on the pain score while walking 24 hours after total knee arthroplasty.
Here are the two protocols compared :
- Adductor canal block followed by continuous perineural perfusion for 48 hours
- Adductor canal block (single shot) followed by hydromorphone extended release formulation for 48 hours In addition to analgesic adjuvants administered in both groups : acetaminophen, celecoxib, pregabalin, dexamethasone and periarticular infiltration.
Our hypothesis is that both protocols ensure a similar analgesia.
Our secondary issues are the proportion of patient that achieve a pain score at walk < 4, the time for the 10 m walk test, the incidence of drowsiness, nausea and vomiting and the postoperative opioid use at 24 and 48 hours postoperatively.
This clinical trial is relevant since it aims to answer a frequently asked question in clinical practice, and its outcome will have a direct impact on the anesthetic practice. In addition, it aims to improve early postoperative mobilization with acceptable pain, which is important after orthopedic surgery.
Methodology
Study design This will be a prospective, randomized, double blind study.
Population Patients undergoing elective TKA
Duration of study 18 months
Sample size Assuming a walking pain score at day 1 of 4.8 (± 2.3) with continuous infusion adductor canal block, periarticular infiltration and analgesic adjuvants, 69 patients per group will detect a difference of 25% between pain scores in both groups, with a power of 90% and an alpha = 0.05. In order to compensate for the losses at follow-up, a total of 150 patients will be recruited.
- Conditions
- Postoperative Pain
- Being tested
- Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 h, Extended Release Capsule
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 hDrug
Also called Continous naropin infusion
Group C receive the intervention Group U receives the placebo See arm description
Extended Release CapsuleDrug
Also called Hydromorph Contin 3 mg PO BID for 48 h
Group C receives a placebo for extended release hydromorphone Group U receives Hydromorph Contin 3 mg PO BID
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Adductor canal block performed in the pre-operative period with 20 mL of Ropivacaïne 0.5%, followed with a continuous perineural infusion of Ropivacaïne 0.2%, 5 ml/h for 48 hours via a perineural catheter.
They will also receive a placebo of Hydromorph Contin 3 mg, administered twice daily for 48h, starting on the evening after surgery Receives: Drug: Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 h |
| Group U | Active comparator | Adductor canal block performed in the pre-operative period with 30 mL of Ropivacaïne 0.5%. A catheter is inserted in the adductor canal but no perineurial infusion. The catheter is connected to a pump that is shut down.
They will also receive Hydromorph Contin 3 mg PO administered twice daily for 48 h, starting on the evening after surgery. 4 doses total Receives: Drug: Extended Release Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score during walking (24 hours)
Verbal Numeric Scale pain score (0-10, where 0= no pain and 10= worst conceivable pain) during walking
Measured: 24 hours postoperatively
Secondary outcomes (18)
Pain score during walking (48 hours)
Verbal Numeric Scale pain score (0-10, where 0= no pain and 10= worst conceivable pain) during walking
Measured: 48 hours postoperatively
Pain score at rest (24 hours)
Verbal Numeric Scale pain score (0-10, where 0= no pain and 10= worst conceivable pain) at rest
Measured: 24 hours postoperatively
Pain score at rest (48 hours)
Verbal Numeric Scale pain score (0-10, where 0= no pain and 10= worst conceivable pain) at rest
Measured: 48 hours postoperatively
Pain score at knee flexion (24 hours)
Pain score (Verbal Numeric Scale (0-10, where 0= no pain and 10= worst conceivable pain) at knee flexion
Measured: 24 hours postoperatively
Pain score at knee flexion (48 hours)
Pain score (Verbal Numeric Scale (0-10, where 0= no pain and 10= worst conceivable pain) at knee flexion
Measured: 48 hours postoperatively
Degree of knee flexion (24 hours)
Knee flexion (degrees) measured using a goniometer. More degrees indicates better knee flexion
Measured: 24 hours postoperatively
Degree of knee flexion (48 hours)
Knee flexion (degrees) measured using a goniometer. More degrees indicates better knee flexion
Measured: 48 hours postoperatively
10 minutes walking test (24 hours)
Number of meters walked during a 10 minutes period.
Measured: 24 hours postoperatively
10 minutes walking test (48 hours)
Number of meters walked during a 10 minutes period
Measured: 48 hours postoperatively
Incidence of Postoperative Nausea (24 hours)
number of patients experiencing postoperative nausea
Measured: 24 hours postoperatively
Incidence of Postoperative Vomiting (24 hours)
number of patients experiencing postoperative vomiting
Measured: 24 hours postoperatively
Incidence of Postoperative Nausea (48 hours)
Number of patients experiencing postoperative nausea
Measured: 48 hours postoperatively
Incidence of Postoperative Vomiting (48 hours)
Number of patients experiencing postoperative vomiting
Measured: 48 hours postoperatively
sedation score(24 hours)
Degree of sedation experienced by patients using a sedation scale score (0-3, where 0 = awake, no sedation, 3= asleep, impossible to arouse).
Measured: 24 hours postoperatively
sedation (48 hours)
Degree of sedation experienced by patients using a sedation scale score (0-3, where 0 = awake, no sedation, 3= asleep, impossible to arouse).)
Measured: 48 hours postoperatively
QoR-40 (48 hours)
Measurement of quality of recovery using the QoR-40 questionnaire. A greater score indicates better recovery profile
Measured: 48 hours postoperatively
Cumulative opioïd dose (24 hours)
Cumulative dose of hydromorphone (milligrams) consumed for postoperative pain
Measured: 24 hours postoperatively
Cumulative opioïd dose (48 hours)
Cumulative dose of hydromorphone (milligrams) consumed for postoperative pain
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Aug 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Why it stopped: Recruitment problems making the study completion unlikely
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two multimodal analgesic protocols will be compared. Patients will be randomized to one of two analgesic protocol: C: Single-shot adductor canal block followed by a 48h perineurial continuous infusion of ropivacaine U: Single-shot adductor canal block and post operative extended release hydromorphone for 48h (4 doses)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronique Brulotte, Maisonneuve-Rosemont Hospital
- Investigators
- Veronique Brulotte, MD, Principal investigator, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990038
- Sponsor's protocol ID
- MultimodalTKA
- Status last verified
- Jan 2020
- First submitted
- 15 Jun 2019
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Multimodal Analgesia Regimens for Total Knee Arthroplasty : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03990038
- Acronym / sponsor ID
- MultimodalTKA
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems making the study completion unlikely
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 18 Jun 2019 (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 improvement of postoperative analgesia is an important issue in orthopedic surgery, especially after total knee arthroplasty The use of a peripheral nerve block such as the adductor canal block is favored since it offers a postoperative analgesia superior to opioids, and also preserves the strength of the quadriceps, as opposed to the femoral block.
The adductor canal block can be given as a single injection (single shot) or a continuous perineural infusion to extend the block's analgesic duration. It is unclear if the continuous infusion is superior to the single shot. Indeed, a high catheter dislodgement rate is observed for this location and local anesthetics could migrate into the femoral canal, resulting in quadriceps weakness. Alternatively, adequate postoperative analgesia has been shown effective with a single shot adductor canal block combined with extended release opioids.
The primary objective in this study is to compare two analgesic protocols on the pain score at walk 24 hours after total knee arthroplasty.
Here are the two protocols compared :
- Adductor canal block followed by continuous perineural perfusion for 48 hours
- Adductor canal block (single shot) followed by hydromorphone extended release formulation for 48 hours In addition to analgesic adjuvants administered in both groups : acetaminophen, celecoxib, pregabalin, dexamethasone and periarticular infiltration.
Our hypothesis is that both protocols ensure a similar analgesia.
Detailed description
The improvement of postoperative analgesia is an important issue in orthopedic surgery, especially after total knee arthroplasty. The early postoperative mobilization of these patients is crucial to ensure a favorable functional evolution, and this goal can't be accomplished without effective analgesia. Opioids offer an efficient pain relief, but their consumption can result in side effects that can increase the length of hospital stay. The use of a peripheral nerve block, such as the adductor canal block (BCA) is a widely favored alternative since it allows postoperative analgesia superior to opioids while preserving the strength of the quadriceps.
For a long period of time, the femoral block has been the most popular peripheral nerve block for patients after a knee arthroplasty. However, this perineural block is associated with an important rate of quadriceps' weakness, which could impair the post-operative mobilization and expose the patient to a risk of falling. It has now been widely replaced by the adductor canal block. The latter has the advantage of providing analgesia at rest and during movement equivalent to the femoral block, while preserving the quadriceps strength and offering a better mobility in the first 24 hours after surgery. In opposition to the femoral block, the adductor canal block does not increase the risk of falling since it is mainly a sensitive block.
The adductor canal block is an advantageous analgesic modality for patients after TKA, but it is limited since it offers only analgesia to the anteromedial aspect of the knee, sparing the lateral and posterior faces. It is common to combine this block with a periarticular knee infiltration with local anesthetics, performed by the surgical team at the end of the surgery. The two modalities combined make it possible to achieve very low pains scores at rest and during walking, compared to both techniques used separately.
The adductor canal block can be administered in one unique injection or with a perineural continuous infusion, to extend the block's analgesic duration. However, it is uncertain whether there is an advantage to use a continuous infusion. There is a significant rate of catheter migrating out of the adductor canal and losing effect. There is also the possibility that the continuous infusion results in a proximal extent of local anesthetic in the femoral canal, generating quadriceps weakness that invalidates the benefits for ACB in the context of postoperative mobilization.
Indeed, the location of the catheter near the surgical site predisposes it to be dislodged out of the adductor canal during surgical manipulations in a significant proportion of patients. A rate as high as 30% of catheter dislodgement on postoperative day 1 was observed. It is possible to perform the block after surgery, before the dressing is applied, but this practice tends to create delays, which are not desirable in the actual context of optimization of the OR time.
In addition, perineural catheters require a strict surveillance by a specialized team and could interfere with patient mobilization because of the restriction associated with the equipment involved. It is reasonable to think that the absence of a catheter and an infusion pump offers an easier mobilization, although this has not been validated in clinical trials.
Finally, continuous infusions increase the cumulative dose of local anesthetics that the patients is exposed to. In order to reduce the toxicity risk, it is necessary to reduce the periarticular infiltration doses, which could impair the quality of analgesia.
Alternatively, it has been demonstrated that adequate post-operative analgesia could be obtained with an adductor canal block, combined with extended release opioids. Several clinical trials involving patients after total knee arthroplasty have shown that there is a benefit to using extended release opioids added to a multimodal analgesia protocol. Their pharmacokinetic profile ensures a more constant analgesia, while offering a safety profile similar to immediate release opioids, a lesser risk of respiratory depression and overdose. The usage of extended release opioids after TKA is justified since patients accuse moderate to severe pain during the first days after surgery, despite the use of a multimodal analgesia protocol and sustained consumption of immediate release opioids.
These two protocols have not been compared.
In conclusion, there is a consensus that postoperative analgesia in patients after TKA should be addressed with a multimodal analgesia protocol that includes a perineural block and analgesic adjuvants. However, the optimal composition of this protocol is not well defined. In our hospital center, the postoperative analgesia protocol for TKA includes a continuous adductor canal block for 48 hours, intravenous dexamethasone, periarticular infiltration of the posterior capsule by the surgeon and analgesic adjuvants such as acetaminophen, celecoxib and pregabalin.
Study outcome and hypothesis
The primary objective in this study is to compare two analgesic protocols on the pain score while walking 24 hours after total knee arthroplasty.
Here are the two protocols compared :
- Adductor canal block followed by continuous perineural perfusion for 48 hours
- Adductor canal block (single shot) followed by hydromorphone extended release formulation for 48 hours In addition to analgesic adjuvants administered in both groups : acetaminophen, celecoxib, pregabalin, dexamethasone and periarticular infiltration.
Our hypothesis is that both protocols ensure a similar analgesia.
Our secondary issues are the proportion of patient that achieve a pain score at walk < 4, the time for the 10 m walk test, the incidence of drowsiness, nausea and vomiting and the postoperative opioid use at 24 and 48 hours postoperatively.
This clinical trial is relevant since it aims to answer a frequently asked question in clinical practice, and its outcome will have a direct impact on the anesthetic practice. In addition, it aims to improve early postoperative mobilization with acceptable pain, which is important after orthopedic surgery.
Methodology
Study design This will be a prospective, randomized, double blind study.
Population Patients undergoing elective TKA
Duration of study 18 months
Sample size Assuming a walking pain score at day 1 of 4.8 (± 2.3) with continuous infusion adductor canal block, periarticular infiltration and analgesic adjuvants, 69 patients per group will detect a difference of 25% between pain scores in both groups, with a power of 90% and an alpha = 0.05. In order to compensate for the losses at follow-up, a total of 150 patients will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two multimodal analgesic protocols will be compared. Patients will be randomized to one of two analgesic protocol: C: Single-shot adductor canal block followed by a 48h perineurial continuous infusion of ropivacaine U: Single-shot adductor canal block and post operative extended release hydromorphone for 48h (4 doses)
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Drug: Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 hAdductor canal block performed in the pre-operative period with 20 mL of Ropivacaïne 0.5%, followed with a continuous perineural infusion of Ropivacaïne 0.2%, 5 ml/h for 48 hours via a perineural catheter. They will also receive a placebo of Hydromorph Contin 3 mg, administered twice daily for 48h, starting on the evening after surgery |
| Group U | Active comparator | Drug: Extended Release CapsuleAdductor canal block performed in the pre-operative period with 30 mL of Ropivacaïne 0.5%. A catheter is inserted in the adductor canal but no perineurial infusion. The catheter is connected to a pump that is shut down. They will also receive Hydromorph Contin 3 mg PO administered twice daily for 48 h, starting on the evening after surgery. 4 doses total |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-80 years old
- American Society of Anesthesiology physical status I-III
- Primary total knee arthroplasty surgery under regional anesthesia
Key exclusion criteria (11 listed)
- Chronic kidney disease (CKD) with eGFR < 60mL/min
- Contraindications for the use of spinal anesthesia or adductor canal block : infection, sepsis, evolutive neurological disease, coagulopathy, patient refusal.
- Chronic use of opioids (>30 mg daily morphine equivalent)
- Documented allergy to Hydromorphone, tramadol, celecoxib, ropivacaine, pregabalin, acetaminophen and/or ketorolac
- Patient weight < 50 kg or BMI > 40
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 |
|---|---|---|
| Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 hAlso: Continous naropin infusionGroup C receive the intervention Group U receives the placebo See arm description | Drug | Group C |
| Extended Release CapsuleAlso: Hydromorph Contin 3 mg PO BID for 48 hGroup C receives a placebo for extended release hydromorphone Group U receives Hydromorph Contin 3 mg PO BID See arm description | Drug | Group U |
Primary outcome
Pain score during walking (24 hours)
Time frame: 24 hours postoperatively
Verbal Numeric Scale pain score (0-10, where 0= no pain and 10= worst conceivable pain) during walking
18 secondary outcomes
Pain score during walking (48 hours)
Time frame: 48 hours postoperatively
Pain score at rest (24 hours)
Time frame: 24 hours postoperatively
Pain score at rest (48 hours)
Time frame: 48 hours postoperatively
Pain score at knee flexion (24 hours)
Time frame: 24 hours postoperatively
Pain score at knee flexion (48 hours)
Time frame: 48 hours postoperatively
Degree of knee flexion (24 hours)
Time frame: 24 hours postoperatively
Degree of knee flexion (48 hours)
Time frame: 48 hours postoperatively
10 minutes walking test (24 hours)
Time frame: 24 hours postoperatively
10 minutes walking test (48 hours)
Time frame: 48 hours postoperatively
Incidence of Postoperative Nausea (24 hours)
Time frame: 24 hours postoperatively
Incidence of Postoperative Vomiting (24 hours)
Time frame: 24 hours postoperatively
Incidence of Postoperative Nausea (48 hours)
Time frame: 48 hours postoperatively
Incidence of Postoperative Vomiting (48 hours)
Time frame: 48 hours postoperatively
sedation score(24 hours)
Time frame: 24 hours postoperatively
sedation (48 hours)
Time frame: 48 hours postoperatively
QoR-40 (48 hours)
Time frame: 48 hours postoperatively
Cumulative opioïd dose (24 hours)
Time frame: 24 hours postoperatively
Cumulative opioïd dose (48 hours)
Time frame: 48 hours postoperatively
Results and safety
The study was stopped early (reason given: Recruitment problems making the study completion unlikely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- 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.
Veronique Brulotte, MD principal investigator
Ciusss de L'Est de l'Île de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 h and Extended Release Capsule in people with Postoperative Pain, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 11 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: stopped early, as of the sponsor's last update on 2 Dec 2024. 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 Canada. 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. 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 was stopped early (reason given: Recruitment problems making the study completion unlikely). Results are not available in the source record.
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 score during walking (24 hours) (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 2 Dec 2024.