Total Knee ArthroplastyPhase 4NCT02798835
Single Injection Adductor Canal Block vs Catheter for Total Knee Arthroplasty
A Phase 4 study testing Adductor canal block, Adductor canal block with dexamethasone and Adductor canal catheter in people with Total Knee Arthroplasty, run by University of British Columbia.
Trial summary
This study investigates single injection adductor canal block (ACB) with or without intravenous dexamethasone and adductor canal catheter for pain management of total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Adductor canal block, Adductor canal block with dexamethasone and Adductor canal catheter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent
- Patients with an American Society of Anaesthesiology (ASA) classification 1 to 3
- Patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30 mg morphine equivalents
- Patients must be able to understand and be able to use patient controlled analgesia
- Patients must be undergoing a primary total knee arthroplasty with neuraxial anesthesia
Who cannot join
- Patients with a contraindication to neuraxial and/or regional anaesthesia
- Patients with an allergy to local anaesthetics
- Patients who have chronic pain not related to their knee joint
- Patients with chronic opioid use (daily or almost daily use >3 months)
- Patients with contraindications to dexamethasone (allergy, infection, Insulin dependent Diabetes Mellitus)
- Patients with pre-existing neuropathy
Show all 9Show fewer
- Patients with hepatic failure
- Patients with renal failure with eGFR<60
- Patients with allergy to ketorolac or NSAIDs
About this study
Official title: Adductor Canal Block: Single Injection vs Catheter for Pain Management of Total Knee Arthroplasty - A Randomized, Unblinded, Non-Inferiority Trial
This study investigates single injection adductor canal block (ACB) with or without intravenous dexamethasone and adductor canal catheter for pain management of total knee arthroplasty. This is a non-inferiority trial seeking to determine whether single injection ACB with dexamethasone is "no worse" than a continuous catheter.
Read the detailed description
- Purpose To determine whether single shot adductor canal nerve blocks with intravenous dexamethasone are non-inferior to continuous adductor canal blockade.
- Hypotheses The use of adductor canal nerve block with intravenous dexamethasone will not be inferior to continuous adductor canal blockade for opioid requirements 24h post operatively. The single injection adductor canal block without dexamethasone will have the most opioid consumption. The dexamethasone and catheter groups will be superior to single injection alone in terms of 12 and 48h opioid consumption, length of stay, anti-emetic usage, pain score and quality of recovery score.
- Justification Total knee arthroplasty is a very commonly performed operation in North America, with a high propensity for postoperative pain. Inadequate analgesia limits functional recovery and leads to delays in hospital discharge, as a result of poor mobility. Effective analgesia allows for earlier mobilization and improved postoperative recovery, with a multi-modal regime being the ideal method to achieve this. Currently a multi-modal regime is provided to patients: intraoperatively with a neuraxial technique (spinal anesthesia), along with surgeon infiltrated local anesthetic at the end of the operation, and then postoperatively using systemic opioids via patient controlled analgesia (PCA). Opioids have many side effects, including nausea and vomiting, sedation, respiratory depression and urinary retention. These all lead to delay in ambulation and recovery. Many centers now incorporate peripheral nerve blocks as part of the multi-modal analgesic regime, with continuous femoral nerve blockade being commonly used for analgesia. This does decrease the amount of postoperative opioid used, but has the downside of causing quadriceps muscle weakness leading to an increased risk of falls and delayed ambulation. For this reason, there has been an increase in the use of the adductor canal block, a nerve block of the distal femoral nerve at the mid-thigh level, that has been shown to preserve quadriceps function better than a femoral nerve block, whilst still ensuring decreased opioid use. To date, no studies have compared single shot adductor canal block with continuous adductor canal blockade, but both have been shown to be comparable to femoral nerve blockade, whilst decreasing the likelihood of quadriceps muscle weakness. Further to this, it has been shown that the addition of dexamethasone, administered via the intravenous or perineural route to peripheral nerve blockade, prolongs the duration of analgesia. Perineural administration of dexamethasone is an off label use and there is also a theoretical risk of neurotoxicity from dexamethasone itself. Findings to date indicate that the efficacy of dexamethasone administered intravenously is non-inferior to perineural injection. Both routes prolong the analgesic benefit of peripheral nerve blocks with similar reductions in opioid requirements. Opioid PCA is the most commonly used modality for postoperative analgesia following total knee arthroplasty. The information from this study will enable ascertainment of the best method for allowing patients good functional recovery, whilst minimizing opioid side effects.
- Objectives The primary aim of this study is to compare the efficacy of adductor canal nerve block, with and without intravenous dexamethasone, and continuous adductor canal blockade with a catheter to ascertain cumulative opioid consumption post-operatively. Specifically, the trial seeks to answer whether the adductor canal block with dexamethasone fares no worse (non-inferior) than a continuous catheter. The secondary aims are to compare the quality of anesthesia recovery using the QoR-40 questionnaire administered at 48 hours postoperatively, pain score, length of hospital stay, complications of nerve blockade, incidence of catheter dislodgement and opioid side effects (nausea/vomiting) with the different techniques.
- Research Methods Trial Design This will be a randomize controlled, non-blinded, non-inferiority trial, involving patients having primary unilateral total knee arthroplasty. There are three arms: adductor canal single injection (baseline control), adductor canal single injection plus dexamethasone (test intervention) and adductor canal catheter (active control). Setting This will be a single-centre trial at UBC Hospital (UBCH).
- Randomization Prior to surgery, for each consented patient, a sealed unmarked opaque envelope will be opened to determine the modality of analgesia that the patient will receive. The patients will either receive an adductor canal block postoperatively, an adductor canal block postoperatively along with intravenous dexamethasone, or have an adductor canal catheter placed postoperatively for continuous adductor canal blockade.
- Data Collection Demographic data including patient age, sex, height, weight, BMI, and medications including analgesics, comorbidities and American Society of Anesthesia (ASA) classification will be determined from the anesthetic record. Numerical Rating Scale (NRS) pain scores from 0-10 as well as cumulative opioid consumption in oral morphine equivalents will be determined at set time points of 12, 24, 48 hours. The data will be determined from the patient's pain flow sheet and medication administration record (MAR), which are part of the standard charting found on the hospital ward. Opioid data from PCA will be obtained from the hospital database which electronically logs usage. The patient's chart will also be used to note anti-emetic medication usage. At 48 hours, all participants will be provided with a QoR-40 questionnaire, a validated 40 item questionnaire on the quality of recovery from anesthesia. The time of discharge will be recorded from the hospital data base. Complications from adductor canal catheters will be recorded, such as catheter dislodgement and site infection. For patients unable to complete the study, the reason will be noted and data will be included in an intention to treat analysis.
- Statistical Analysis Sample Size: The investigators do not have institutional data of standard deviation (SD) of morphine equivalent consumption for primary total knee arthroplasty. Based on previous studies, the standard deviation of morphine equivalent consumption at 24h is estimated to be 20 mg IV. We consider a reduction of 10 mg to be clinically relevant at this time point and therefore set it as the non-inferiority margin. Using the following online calculator: https://www.sealedenvelope.com/power/continuous-noninferior/ based on a power of 80% and significance level of 5%, the number of patients required per group is 50. The aim is to recruit 60 patients per group to account for potential drop outs.
- Data Analysis: Categorical data will be analysed with chi-squared tests. Numeric variables will be compared with independent T-tests if distributions were normal. If Kolmogorov-Smirnoff test for normality of distribution was significant non-parametric Mann Whitney U tests will be utilized. Statistical significance will be assumed if P <0.05.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Adductor canal block, Adductor canal block with dexamethasone, Adductor canal catheter, Bupivacaine, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal blockDrug
Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Adductor canal block with dexamethasoneDrug
Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Adductor canal catheterDrug
Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
BupivacaineDrug
Used in spinal anesthetic
FentanylDrug
May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable SolutionDrug
Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
DexamethasoneDrug
To be given intravenously at time of nerve block to one of the study arms.
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal block | Active comparator | Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB. Receives: Drug: Adductor canal block; Drug: Bupivacaine; Drug: Fentanyl; Drug: Ropivacaine 0.5% Injectable Solution |
| Adductor canal block with dexamethasone | Active comparator | Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone. Receives: Drug: Adductor canal block with dexamethasone; Drug: Bupivacaine; Drug: Fentanyl; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Dexamethasone |
| Adductor canal catheter | Active comparator | Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours. Receives: Drug: Adductor canal catheter; Drug: Bupivacaine; Drug: Fentanyl; Drug: Ropivacaine 0.5% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative 24 Hour Oral Morphine Equivalent Consumption
Post-operative analgesia at 24 hours
Measured: 24 hours (Day 1)
Secondary outcomes (7)
Cumulative 12 Hour Oral Morphine Equivalent Consumption
Post-operative analgesia at 12 hours
Measured: 12 hours (Day 0)
Cumulative 48 Hour Oral Morphine Equivalent Consumption
Post-operative analgesia at 48 hours
Measured: 48 hours (Day 2)
Pain Score
Patient's level of pain using NRS (Numeric Ratings Scale) pain scale where the range is 0 (no pain) to 10 (worst pain)
Measured: 12, 24 and 48 hours
Quality of Recovery (QoR-40)
Quality of recovery measured using the QoR-40 at 48 hours postoperatively. This is a validated scale where a higher score denotes better recovery/satisfaction after surgery. The range is 40-200.
Measured: 48 hours (Day 2)
Length of Stay
Time to hospital discharge
Measured: From surgical date until hospital discharge, up to 3 weeks
Incidence of Participants With Nausea/Vomiting Requiring Anti-emetics
Number of Participants with Nausea/Vomiting requiring anti-emetics from 0-48 hours after surgery.
Measured: 0 to 48 hours
Time to First Use of PCA
from time zero to first press of PCA button
Measured: 0 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Lee, University of British Columbia
- Investigators
- Steven Lee, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798835
- Sponsor's protocol ID
- H16-01058
- Status last verified
- Sep 2020
- First submitted
- 9 Jun 2016
- Last updated
- 4 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Perlas A, Kirkham KR, Billing R, Tse C, Brull R, Gandhi R, Chan VW. The impact of analgesic modality on early ambulation following total knee arthroplasty. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):334-9. doi: 10.1097/AAP.0b013e318296b6a0.
PubMed 23759708Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
PubMed 24401769Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. doi: 10.1097/00000539-199807000-00020.
PubMed 9661553Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.
PubMed 21394001Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
PubMed 23241723Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
PubMed 22221014Abdallah FW, Johnson J, Chan V, Murgatroyd H, Ghafari M, Ami N, Jin R, Brull R. Intravenous dexamethasone and perineural dexamethasone similarly prolong the duration of analgesia after supraclavicular brachial plexus block: a randomized, triple-arm, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):125-32. doi: 10.1097/AAP.0000000000000210.
PubMed 25629321Rahangdale R, Kendall MC, McCarthy RJ, Tureanu L, Doty R Jr, Weingart A, De Oliveira GS Jr. The effects of perineural versus intravenous dexamethasone on sciatic nerve blockade outcomes: a randomized, double-blind, placebo-controlled study. Anesth Analg. 2014 May;118(5):1113-9. doi: 10.1213/ANE.0000000000000137.
PubMed 24686045Lee S, Rooban N, Vaghadia H, Sawka AN, Tang R. A Randomized Non-Inferiority Trial of Adductor Canal Block for Analgesia After Total Knee Arthroplasty: Single Injection Versus Catheter Technique. J Arthroplasty. 2018 Apr;33(4):1045-1051. doi: 10.1016/j.arth.2017.11.018. Epub 2017 Nov 16.
PubMed 29198872
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block: Single Injection vs Catheter for Pain Management of Total Knee Arthroplasty - A Randomized, Unblinded, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT02798835
- Acronym / sponsor ID
- H16-01058
- Conditions
- Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Posted 4 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates single injection adductor canal block (ACB) with or without intravenous dexamethasone and adductor canal catheter for pain management of total knee arthroplasty. This is a non-inferiority trial seeking to determine whether single injection ACB with dexamethasone is "no worse" than a continuous catheter.
Detailed description
- Purpose To determine whether single shot adductor canal nerve blocks with intravenous dexamethasone are non-inferior to continuous adductor canal blockade.
- Hypotheses The use of adductor canal nerve block with intravenous dexamethasone will not be inferior to continuous adductor canal blockade for opioid requirements 24h post operatively. The single injection adductor canal block without dexamethasone will have the most opioid consumption. The dexamethasone and catheter groups will be superior to single injection alone in terms of 12 and 48h opioid consumption, length of stay, anti-emetic usage, pain score and quality of recovery score.
- Justification Total knee arthroplasty is a very commonly performed operation in North America, with a high propensity for postoperative pain. Inadequate analgesia limits functional recovery and leads to delays in hospital discharge, as a result of poor mobility. Effective analgesia allows for earlier mobilization and improved postoperative recovery, with a multi-modal regime being the ideal method to achieve this. Currently a multi-modal regime is provided to patients: intraoperatively with a neuraxial technique (spinal anesthesia), along with surgeon infiltrated local anesthetic at the end of the operation, and then postoperatively using systemic opioids via patient controlled analgesia (PCA). Opioids have many side effects, including nausea and vomiting, sedation, respiratory depression and urinary retention. These all lead to delay in ambulation and recovery. Many centers now incorporate peripheral nerve blocks as part of the multi-modal analgesic regime, with continuous femoral nerve blockade being commonly used for analgesia. This does decrease the amount of postoperative opioid used, but has the downside of causing quadriceps muscle weakness leading to an increased risk of falls and delayed ambulation. For this reason, there has been an increase in the use of the adductor canal block, a nerve block of the distal femoral nerve at the mid-thigh level, that has been shown to preserve quadriceps function better than a femoral nerve block, whilst still ensuring decreased opioid use. To date, no studies have compared single shot adductor canal block with continuous adductor canal blockade, but both have been shown to be comparable to femoral nerve blockade, whilst decreasing the likelihood of quadriceps muscle weakness. Further to this, it has been shown that the addition of dexamethasone, administered via the intravenous or perineural route to peripheral nerve blockade, prolongs the duration of analgesia. Perineural administration of dexamethasone is an off label use and there is also a theoretical risk of neurotoxicity from dexamethasone itself. Findings to date indicate that the efficacy of dexamethasone administered intravenously is non-inferior to perineural injection. Both routes prolong the analgesic benefit of peripheral nerve blocks with similar reductions in opioid requirements. Opioid PCA is the most commonly used modality for postoperative analgesia following total knee arthroplasty. The information from this study will enable ascertainment of the best method for allowing patients good functional recovery, whilst minimizing opioid side effects.
- Objectives The primary aim of this study is to compare the efficacy of adductor canal nerve block, with and without intravenous dexamethasone, and continuous adductor canal blockade with a catheter to ascertain cumulative opioid consumption post-operatively. Specifically, the trial seeks to answer whether the adductor canal block with dexamethasone fares no worse (non-inferior) than a continuous catheter. The secondary aims are to compare the quality of anesthesia recovery using the QoR-40 questionnaire administered at 48 hours postoperatively, pain score, length of hospital stay, complications of nerve blockade, incidence of catheter dislodgement and opioid side effects (nausea/vomiting) with the different techniques.
- Research Methods Trial Design This will be a randomize controlled, non-blinded, non-inferiority trial, involving patients having primary unilateral total knee arthroplasty. There are three arms: adductor canal single injection (baseline control), adductor canal single injection plus dexamethasone (test intervention) and adductor canal catheter (active control). Setting This will be a single-centre trial at UBC Hospital (UBCH).
- Randomization Prior to surgery, for each consented patient, a sealed unmarked opaque envelope will be opened to determine the modality of analgesia that the patient will receive. The patients will either receive an adductor canal block postoperatively, an adductor canal block postoperatively along with intravenous dexamethasone, or have an adductor canal catheter placed postoperatively for continuous adductor canal blockade.
- Data Collection Demographic data including patient age, sex, height, weight, BMI, and medications including analgesics, comorbidities and American Society of Anesthesia (ASA) classification will be determined from the anesthetic record. Numerical Rating Scale (NRS) pain scores from 0-10 as well as cumulative opioid consumption in oral morphine equivalents will be determined at set time points of 12, 24, 48 hours. The data will be determined from the patient's pain flow sheet and medication administration record (MAR), which are part of the standard charting found on the hospital ward. Opioid data from PCA will be obtained from the hospital database which electronically logs usage. The patient's chart will also be used to note anti-emetic medication usage. At 48 hours, all participants will be provided with a QoR-40 questionnaire, a validated 40 item questionnaire on the quality of recovery from anesthesia. The time of discharge will be recorded from the hospital data base. Complications from adductor canal catheters will be recorded, such as catheter dislodgement and site infection. For patients unable to complete the study, the reason will be noted and data will be included in an intention to treat analysis.
- Statistical Analysis Sample Size: The investigators do not have institutional data of standard deviation (SD) of morphine equivalent consumption for primary total knee arthroplasty. Based on previous studies, the standard deviation of morphine equivalent consumption at 24h is estimated to be 20 mg IV. We consider a reduction of 10 mg to be clinically relevant at this time point and therefore set it as the non-inferiority margin. Using the following online calculator: https://www.sealedenvelope.com/power/continuous-noninferior/ based on a power of 80% and significance level of 5%, the number of patients required per group is 50. The aim is to recruit 60 patients per group to account for potential drop outs.
- Data Analysis: Categorical data will be analysed with chi-squared tests. Numeric variables will be compared with independent T-tests if distributions were normal. If Kolmogorov-Smirnoff test for normality of distribution was significant non-parametric Mann Whitney U tests will be utilized. Statistical significance will be assumed if P <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal block | Active comparator | Drug: Adductor canal block, Drug: Bupivacaine, Drug: Fentanyl, Drug: Ropivacaine 0.5% Injectable SolutionPostoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB. |
| Adductor canal block with dexamethasone | Active comparator | Drug: Adductor canal block with dexamethasone, Drug: Bupivacaine, Drug: Fentanyl, Drug: Ropivacaine 0.5% Injectable Solution, Drug: DexamethasonePostoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone. |
| Adductor canal catheter | Active comparator | Drug: Adductor canal catheter, Drug: Bupivacaine, Drug: Fentanyl, Drug: Ropivacaine 0.5% Injectable SolutionPostoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent
- Patients with an American Society of Anaesthesiology (ASA) classification 1 to 3
- Patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30 mg morphine equivalents
- Patients must be able to understand and be able to use patient controlled analgesia
- Patients must be undergoing a primary total knee arthroplasty with neuraxial anesthesia
Key exclusion criteria (9 listed)
- Patients with a contraindication to neuraxial and/or regional anaesthesia
- Patients with an allergy to local anaesthetics
- Patients who have chronic pain not related to their knee joint
- Patients with chronic opioid use (daily or almost daily use >3 months)
- Patients with contraindications to dexamethasone (allergy, infection, Insulin dependent Diabetes Mellitus)
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 blockSpinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU. | Drug | Adductor Canal block |
| Adductor canal block with dexamethasoneSpinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU. | Drug | Adductor canal block with dexamethasone |
| Adductor canal catheterSpinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started. | Drug | Adductor canal catheter |
| BupivacaineUsed in spinal anesthetic | Drug | Adductor Canal block, Adductor canal block with dexamethasone, Adductor canal catheter |
| FentanylMay or may not be used in spinal anesthetic | Drug | Adductor Canal block, Adductor canal block with dexamethasone, Adductor canal catheter |
| Ropivacaine 0.5% Injectable SolutionLocal anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block. | Drug | Adductor Canal block, Adductor canal block with dexamethasone, Adductor canal catheter |
| DexamethasoneTo be given intravenously at time of nerve block to one of the study arms. | Drug | Adductor canal block with dexamethasone |
Primary outcome
Cumulative 24 Hour Oral Morphine Equivalent Consumption
Time frame: 24 hours (Day 1)
Post-operative analgesia at 24 hours
7 secondary outcomes
Cumulative 12 Hour Oral Morphine Equivalent Consumption
Time frame: 12 hours (Day 0)
Cumulative 48 Hour Oral Morphine Equivalent Consumption
Time frame: 48 hours (Day 2)
Pain Score
Time frame: 12, 24 and 48 hours
Quality of Recovery (QoR-40)
Time frame: 48 hours (Day 2)
Length of Stay
Time frame: From surgical date until hospital discharge, up to 3 weeks
Incidence of Participants With Nausea/Vomiting Requiring Anti-emetics
Time frame: 0 to 48 hours
Time to First Use of PCA
Time frame: 0 to 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23759708Perlas A, Kirkham KR, Billing R, Tse C, Brull R, Gandhi R, Chan VW. The impact of analgesic modality on early ambulation following total knee arthroplasty. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):334-9. doi: 10.1097/AAP.0b013e318296b6a0.
- Background: PubMed 24401769Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
- Background: PubMed 9661553Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. doi: 10.1097/00000539-199807000-00020.
- Background: PubMed 21394001Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.
- Background: PubMed 23241723Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
- Background: PubMed 22221014Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
- Background: PubMed 25629321Abdallah FW, Johnson J, Chan V, Murgatroyd H, Ghafari M, Ami N, Jin R, Brull R. Intravenous dexamethasone and perineural dexamethasone similarly prolong the duration of analgesia after supraclavicular brachial plexus block: a randomized, triple-arm, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):125-32. doi: 10.1097/AAP.0000000000000210.
- Background: PubMed 24686045Rahangdale R, Kendall MC, McCarthy RJ, Tureanu L, Doty R Jr, Weingart A, De Oliveira GS Jr. The effects of perineural versus intravenous dexamethasone on sciatic nerve blockade outcomes: a randomized, double-blind, placebo-controlled study. Anesth Analg. 2014 May;118(5):1113-9. doi: 10.1213/ANE.0000000000000137.
- Derived from this study: PubMed 29198872Lee S, Rooban N, Vaghadia H, Sawka AN, Tang R. A Randomized Non-Inferiority Trial of Adductor Canal Block for Analgesia After Total Knee Arthroplasty: Single Injection Versus Catheter Technique. J Arthroplasty. 2018 Apr;33(4):1045-1051. doi: 10.1016/j.arth.2017.11.018. Epub 2017 Nov 16.
- 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.
Steven Lee, MD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adductor canal block, Adductor canal block with dexamethasone and Adductor canal catheter in people with Total Knee Arthroplasty, run by University of British Columbia.
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 5 inclusion and 9 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 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative 24 Hour Oral Morphine Equivalent Consumption (time frame: 24 hours (Day 1)). 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 NCT02798835, which also lists 9 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 4 Sep 2020.