Postoperative PainPhase 3NCT02541552
Effect of Volume of Local Anesthetic for Adductor Canal Block on Quadriceps Muscle Function: A Dose Finding Study
A Phase 3 study testing Ropivacaine 0.5% in people with Postoperative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Adductor canal block is commonly offered to provide pain relief following knee surgery with the hope that they cause less leg weakness than traditionally performed femoral nerve block. Infrequently, adductor canal blocks also result in leg weakness thereby potentially limiting the advantages of the technique. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Nov 2015
- Phase
- Phase 3
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male and females
- Age 16-60 years
- Scheduled surgery
- Knee arthroscopy
- ASA Class I - III
Who cannot join
- Ipsi- or contralateral leg weakness
- Preoperative neurological deficits
- Narcotic dependent (opioid intake more than 3 months)
- Chronic pain conditions
- Significant cardiac and respiratory disease
- Coexisting hematological disorder or with deranged coagulation parameters
Show all 11Show fewer
- Pre-existing major organ dysfunction such as hepatic and renal failure.
- Psychiatric illnesses
- Emergency surgery
- Lack of informed consent
- Allergy to any of the drugs used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Adductor canal block is commonly offered to provide pain relief following knee surgery with the hope that they cause less leg weakness than traditionally performed femoral nerve block. Infrequently, adductor canal blocks also result in leg weakness thereby potentially limiting the advantages of the technique. Investigators want to find out the effective dose for a 30% response (volume of local anesthetic which would result in clinically significant weakness of the leg)
Read the detailed description
This is a sequential design method of binary response variables for determination of the dose associated with the 50% point along the dose-response curve required to cause quadriceps weakness following adductor canal bock for knee arthroscopic procedures. It is a Dixon and Massey up-and-down study design.
The primary objective is finding the EV50 of 0.5% ropivacaine needed to cause a 30% reduction in quadriceps function 20 minutes post-procedure.
This study design was selected to allow the estimation of the target dose associated with the given outcome of quadriceps weakness. The study will be performed on 36 patients undergoing knee arthroscopic procedures. The quadriceps strength on both legs will be evaluated preoperatively by the physiotherapist.
The quadriceps function will be measured using a hand held dynamometer (HDD). For quadriceps muscle strength evaluation, investigators will place the patient in a seated position with the knees flexed 60 degrees. To avoid interrater reliability (when the strength of the subject overcomes the strength of the tester) investigators will fix the HHD for quadriceps evaluation. A non-elastic strap with Velcro closures will be used to fix the HHD. The Velcro strap will be attached to a chair leg and around the subject's ankle, perpendicular to the lower leg. The HHD will be placed under the Velcro strap, on the anterior surface of the tibia, 5 cm above the transmalleolar axis.
Subjects will be educated about the procedure before outcome assessments. They will be instructed to take 2 seconds to reach maximum effort, maintain this force for 3 seconds, and then relax. For each assessment, the subjects will perform 3 consecutive contractions, separated by a 30-second pause between each trial. Investigators will use the mean value at each time point for calculations, and calculated muscle strength as percent of baseline value. An independent investigator not involved in the performance of the block will assess the quadriceps muscle function before, 20 minutes and then 4 hours after the block.
Following initial motor assessment the patients will be taken to the block room for the blocks to be performed using standard monitors which will include NIBP and pulse oximetry.
Patients will be sedated with fentanyl and midazolam titrated to effect and supplemental oxygen will be administered.The first patient will be given 30ml of ropivacaine 0.5% in the adductor canal block.
Depending on post-operative quadriceps function, the dose for the subsequent patient will either be increased by 2ml or decreased by 2ml (of the same concentration).
The adductor canal block procedure will be standardised for each patients. All patients will receive ultrasound guided saphenous nerve block in the adductor canal using 0.5% ropivacaine. After preparing the skin with chlorhexidine in alcohol solution and draping the area, the puncture sites will be infiltrated with 2% lidocaine. A 22 gauge 90 mm peripheral nerve stimulation block needle will be introduced deep to the sartorius muscle using ultrasonography and a linear high frequency probe and 30 ml (initially) of 0.5% ropivacaine will be injected after negative aspiration for blood while observing the spread of injectate.
The injection will be done above the level where the descending genicular artery is taking off from the femoral artery. The cutaneous analgesia over the medial aspect of leg will be tested to evaluate the success of saphenous nerve block 20 minutes after injection. If the descending genicular artery is not visualised on ultrasound, then the block will be performed proximal to where the femoral artery enters the hiatus in adductor magnus.
Total duration of performance and the time for the onset of sensory block in saphenous distribution will be recorded after the performance of the block. The failure rate of saphenous nerve block will be determined by the performer. Patients with failure of saphenous nerve block will be excluded from the efficacy part of the study.
After performance of the blocks, the patient will be moved to the operating room for the surgery under general anesthesia according to the choice of the anesthesiologist.
The patients will be assessed for the severity of pain after arrival in the PACU for four hours. Patients quadriceps function will be measured at 4 hours post-operatively. Complications such as bruising and post-block neurological deficits will be prospectively collected.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine 0.5%
- Keywords
- Knee arthroscopy, Quadriceps weakness, ropivacaine, saphenous nerve block, Adductor canal
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.5%Drug
Also called Naropin
Varying volume according to motor response of previous subject
| Study group | Role | What they receive |
|---|---|---|
| Knee arthroscopic patient | Experimental | 1) Male and females 2) Age 16-60 years 3) Scheduled surgery 4) Knee arthroscopy 5) ASA Class I - III
Volume finding study to follow up-and-down design using a single cohort of patients. Intervention of patient will be dependent on effect of previous patients dose of and response to Ropivacaine 0.5% injectate. Receives: Drug: Ropivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the EV50 of anesthetic volume needed to produce >30% reduction of pre-injectate quadriceps strength at 20 minutes following adductor canal block.
Measured by handheld dynamometer
Measured: Percentage difference before block and at 20minutes
Secondary outcomes (2)
Reduced sensation to pin-prick around the anteromedial aspect of the knee
Used to verify successful adductor canal block. scoring of either 0 - normal sensation and can feel pin-prick, 1 - touch only, 2 - no sensation of touch or pinprick
Measured: 20 minutes post-block
Post-operative quadriceps muscle function
Measured by handheld dynamometer
Measured: Percentage difference before block and at 4 hours following block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakesh Sondekoppam Vijayashankar, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541552
- Sponsor's protocol ID
- ADDCAN05
- Status last verified
- Aug 2016
- First submitted
- 17 Mar 2015
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanson NA, Derby RE, Auyong DB, Salinas FV, Delucca C, Nagy R, Yu Z, Slee AE. Ultrasound-guided adductor canal block for arthroscopic medial meniscectomy: a randomized, double-blind trial. Can J Anaesth. 2013 Sep;60(9):874-80. doi: 10.1007/s12630-013-9992-9. Epub 2013 Jul 3.
PubMed 23820968Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
PubMed 18574578Rawal N. Postoperative pain treatment for ambulatory surgery. Best Pract Res Clin Anaesthesiol. 2007 Mar;21(1):129-48. doi: 10.1016/j.bpa.2006.11.005.
PubMed 17489224Jaeger 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 23241723Kim 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 24401769Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):67-72. doi: 10.1016/j.rapm.2006.08.013.
PubMed 17196495Mayr HO, Entholzner E, Hube R, Hein W, Weig TG. Pre- versus postoperative intraarticular application of local anesthetics and opioids versus femoral nerve block in anterior cruciate ligament repair. Arch Orthop Trauma Surg. 2007 May;127(4):241-4. doi: 10.1007/s00402-006-0147-0. Epub 2006 May 23.
PubMed 16721618Chen J, Lesser JB, Hadzic A, Reiss W, Resta-Flarer F. Adductor canal block can result in motor block of the quadriceps muscle. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):170-1. doi: 10.1097/AAP.0000000000000053.
PubMed 24553306Veal C, Auyong DB, Hanson NA, Allen CJ, Strodtbeck W. Delayed quadriceps weakness after continuous adductor canal block for total knee arthroplasty: a case report. Acta Anaesthesiol Scand. 2014 Mar;58(3):362-4. doi: 10.1111/aas.12244. Epub 2013 Dec 26.
PubMed 24372058Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.
PubMed 21044725Bohannon RW, Kindig J, Sabo G, Duni AE, Cram P. Isometric knee extension force measured using a handheld dynamometer with and without belt-stabilization. Physiother Theory Pract. 2012 Oct;28(7):562-8. doi: 10.3109/09593985.2011.640385. Epub 2011 Dec 22.
PubMed 22191509Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
PubMed 24121608Johnston DF, Sondekoppam RV, Giffin R, Litchfield R, Ganapathy S. Determination of ED50 and ED95 of 0.5% Ropivacaine in Adductor Canal Block to Produce Quadriceps Weakness: A Dose-Finding Study. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):731-736. doi: 10.1097/AAP.0000000000000638.
PubMed 28991061
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Volume of Local Anesthetic for Adductor Canal Block on Quadriceps Muscle Function: A Dose Finding Study
- ClinicalTrials.gov ID
- NCT02541552
- Acronym / sponsor ID
- ADDCAN05
- Conditions
- Postoperative Pain
- Keywords
- Knee arthroscopy, Quadriceps weakness, ropivacaine, saphenous nerve block, Adductor canal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Sep 2015 (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.
Adductor canal block is commonly offered to provide pain relief following knee surgery with the hope that they cause less leg weakness than traditionally performed femoral nerve block. Infrequently, adductor canal blocks also result in leg weakness thereby potentially limiting the advantages of the technique. Investigators want to find out the effective dose for a 30% response (volume of local anesthetic which would result in clinically significant weakness of the leg)
Detailed description
This is a sequential design method of binary response variables for determination of the dose associated with the 50% point along the dose-response curve required to cause quadriceps weakness following adductor canal bock for knee arthroscopic procedures. It is a Dixon and Massey up-and-down study design.
The primary objective is finding the EV50 of 0.5% ropivacaine needed to cause a 30% reduction in quadriceps function 20 minutes post-procedure.
This study design was selected to allow the estimation of the target dose associated with the given outcome of quadriceps weakness. The study will be performed on 36 patients undergoing knee arthroscopic procedures. The quadriceps strength on both legs will be evaluated preoperatively by the physiotherapist.
The quadriceps function will be measured using a hand held dynamometer (HDD). For quadriceps muscle strength evaluation, investigators will place the patient in a seated position with the knees flexed 60 degrees. To avoid interrater reliability (when the strength of the subject overcomes the strength of the tester) investigators will fix the HHD for quadriceps evaluation. A non-elastic strap with Velcro closures will be used to fix the HHD. The Velcro strap will be attached to a chair leg and around the subject's ankle, perpendicular to the lower leg. The HHD will be placed under the Velcro strap, on the anterior surface of the tibia, 5 cm above the transmalleolar axis.
Subjects will be educated about the procedure before outcome assessments. They will be instructed to take 2 seconds to reach maximum effort, maintain this force for 3 seconds, and then relax. For each assessment, the subjects will perform 3 consecutive contractions, separated by a 30-second pause between each trial. Investigators will use the mean value at each time point for calculations, and calculated muscle strength as percent of baseline value. An independent investigator not involved in the performance of the block will assess the quadriceps muscle function before, 20 minutes and then 4 hours after the block.
Following initial motor assessment the patients will be taken to the block room for the blocks to be performed using standard monitors which will include NIBP and pulse oximetry.
Patients will be sedated with fentanyl and midazolam titrated to effect and supplemental oxygen will be administered.The first patient will be given 30ml of ropivacaine 0.5% in the adductor canal block.
Depending on post-operative quadriceps function, the dose for the subsequent patient will either be increased by 2ml or decreased by 2ml (of the same concentration).
The adductor canal block procedure will be standardised for each patients. All patients will receive ultrasound guided saphenous nerve block in the adductor canal using 0.5% ropivacaine. After preparing the skin with chlorhexidine in alcohol solution and draping the area, the puncture sites will be infiltrated with 2% lidocaine. A 22 gauge 90 mm peripheral nerve stimulation block needle will be introduced deep to the sartorius muscle using ultrasonography and a linear high frequency probe and 30 ml (initially) of 0.5% ropivacaine will be injected after negative aspiration for blood while observing the spread of injectate.
The injection will be done above the level where the descending genicular artery is taking off from the femoral artery. The cutaneous analgesia over the medial aspect of leg will be tested to evaluate the success of saphenous nerve block 20 minutes after injection. If the descending genicular artery is not visualised on ultrasound, then the block will be performed proximal to where the femoral artery enters the hiatus in adductor magnus.
Total duration of performance and the time for the onset of sensory block in saphenous distribution will be recorded after the performance of the block. The failure rate of saphenous nerve block will be determined by the performer. Patients with failure of saphenous nerve block will be excluded from the efficacy part of the study.
After performance of the blocks, the patient will be moved to the operating room for the surgery under general anesthesia according to the choice of the anesthesiologist.
The patients will be assessed for the severity of pain after arrival in the PACU for four hours. Patients quadriceps function will be measured at 4 hours post-operatively. Complications such as bruising and post-block neurological deficits will be prospectively collected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee arthroscopic patient | Experimental | Drug: Ropivacaine 0.5%1) Male and females 2) Age 16-60 years 3) Scheduled surgery 4) Knee arthroscopy 5) ASA Class I - III Volume finding study to follow up-and-down design using a single cohort of patients. Intervention of patient will be dependent on effect of previous patients dose of and response to Ropivacaine 0.5% injectate. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male and females
- Age 16-60 years
- Scheduled surgery
- Knee arthroscopy
- ASA Class I - III
Key exclusion criteria (11 listed)
- Ipsi- or contralateral leg weakness
- Preoperative neurological deficits
- Narcotic dependent (opioid intake more than 3 months)
- Chronic pain conditions
- Significant cardiac and respiratory disease
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 0.5%Also: NaropinVarying volume according to motor response of previous subject | Drug | Knee arthroscopic patient |
Primary outcome
The primary outcome will be the EV50 of anesthetic volume needed to produce >30% reduction of pre-injectate quadriceps strength at 20 minutes following adductor canal block.
Time frame: Percentage difference before block and at 20minutes
Measured by handheld dynamometer
2 secondary outcomes
Reduced sensation to pin-prick around the anteromedial aspect of the knee
Time frame: 20 minutes post-block
Post-operative quadriceps muscle function
Time frame: Percentage difference before block and at 4 hours following block
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 25 Aug 2016.
- Background: PubMed 23820968Hanson NA, Derby RE, Auyong DB, Salinas FV, Delucca C, Nagy R, Yu Z, Slee AE. Ultrasound-guided adductor canal block for arthroscopic medial meniscectomy: a randomized, double-blind trial. Can J Anaesth. 2013 Sep;60(9):874-80. doi: 10.1007/s12630-013-9992-9. Epub 2013 Jul 3.
- Background: PubMed 18574578Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
- Background: PubMed 17489224Rawal N. Postoperative pain treatment for ambulatory surgery. Best Pract Res Clin Anaesthesiol. 2007 Mar;21(1):129-48. doi: 10.1016/j.bpa.2006.11.005.
- 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 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 17196495Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):67-72. doi: 10.1016/j.rapm.2006.08.013.
- Background: PubMed 16721618Mayr HO, Entholzner E, Hube R, Hein W, Weig TG. Pre- versus postoperative intraarticular application of local anesthetics and opioids versus femoral nerve block in anterior cruciate ligament repair. Arch Orthop Trauma Surg. 2007 May;127(4):241-4. doi: 10.1007/s00402-006-0147-0. Epub 2006 May 23.
- Background: PubMed 24553306Chen J, Lesser JB, Hadzic A, Reiss W, Resta-Flarer F. Adductor canal block can result in motor block of the quadriceps muscle. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):170-1. doi: 10.1097/AAP.0000000000000053.
- Background: PubMed 24372058Veal C, Auyong DB, Hanson NA, Allen CJ, Strodtbeck W. Delayed quadriceps weakness after continuous adductor canal block for total knee arthroplasty: a case report. Acta Anaesthesiol Scand. 2014 Mar;58(3):362-4. doi: 10.1111/aas.12244. Epub 2013 Dec 26.
- Background: PubMed 21044725Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.
- Background: PubMed 22191509Bohannon RW, Kindig J, Sabo G, Duni AE, Cram P. Isometric knee extension force measured using a handheld dynamometer with and without belt-stabilization. Physiother Theory Pract. 2012 Oct;28(7):562-8. doi: 10.3109/09593985.2011.640385. Epub 2011 Dec 22.
- Background: PubMed 24121608Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 Phase 3 study testing Ropivacaine 0.5% in people with Postoperative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 5 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: finished, as of the sponsor's last update on 25 Aug 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary outcome will be the EV50 of anesthetic volume needed to produce >30% reduction of pre-injectate quadriceps strength at 20 minutes following adductor canal block. (time frame: Percentage difference before block and at 20minutes). 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 NCT02541552, which also lists 13 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 25 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.