Anesthesia, RegionalPhase 4NCT02908711
Adductor Canal Block (ACB) Before and After Primary Total Knee Arthroplasty (TKA)
A Phase 4 study testing 0.5% ropivacaine in people with Anesthesia, Regional, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Total knee arthroplasty (TKA) is associated with severe postoperative pain. Multimodal analgesia, including peripheral nerve block, is recommended for post-operative pain relief 1. Perineural analgesia offers the advantage of extended pain relief up to 24 hours after surgery2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Regional
- What is being tested?
- 0.5% ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2016to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study is a prospective, randomized controlled clinical trial comparing two methods of regional analgesia for primary TKA. All adult primary TKA patients are eligible for inclusion in the study.
Who cannot join
- Allergy to local anesthetics or to systemic opioids
- Contraindication to regional anesthesia technique, such as local infection or coagulopathy
- Sensory/motor disorder involving operative limb
- Requirements of more than 30 mg morphine equivalent daily prior to surgery
- ASA 4 or greater
- Psychiatric or cognitive disorders
Show all 11Show fewer
- Incarceration
- Renal insufficiency with Cr > 2.0
- Hepatic failure
- Pregnancy
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Adductor Canal Block (ACB) Before and After Primary Total Knee Arthroplasty (TKA): A Prospective Randomized Trial to Compare Postoperative Clinical Outcomes
Total knee arthroplasty (TKA) is associated with severe postoperative pain. Multimodal analgesia, including peripheral nerve block, is recommended for post-operative pain relief 1. Perineural analgesia offers the advantage of extended pain relief up to 24 hours after surgery2.
This is a prospective, randomized control trial designed to compare the analgesic efficacy of the adductor canal block (ACB) performed immediately before or immediately after primary total knee arthroplasty (TKA). The primary objective of this study is to measure pain score associated with knee motion following TKA among patients receiving ACB as part of their analgesic regimen for TKA. Secondary end points include assessment of postoperative ambulation, range of motion, pain at rest, opioid consumption, and patient satisfaction between the two analgesic approaches. The investigators hypothesize that ACB before the surgery will reduce a patient's postoperative pain and improve patient satisfaction.
Read more
All consecutive patients undergoing primary TKA will be recruited for enrollment in the study. Patients will be for randomized preoperatively to receive either preemptive ABC (PreACB) or postoperative ABC (PostACB). Patients randomized to the PreACB group will receive the block prior to incision. Patients randomized to the PostACB group will receive the block at the end of the surgery. Both techniques are in accordance to the standard of care at our institute. All patients will have the ACB done by a regional anesthesiologist in the regional anesthesia unit, or in the operating room. Patient medical history will be obtained and blocks will be placed per usual protocol. Operative and anesthetic details, including medications given, will be recorded.
Pain scores and pain medications given in the PACU will be recorded. Supplementary analgesics will be provided per institutional PACU protocol. Study data will be recorded for up to 72 hours or until patient discharge. A follow-up will occur in 4- 6 weeks at the orthopedic follow-up appointment to evaluate the patient's late pain scores and overall satisfaction. Data will be analyzed both at the conclusion of the study and at several intervals prior to completion of the study.
Read the detailed description
- Research Design and Methods
Inclusion Criteria:
The study is a prospective, randomized controlled clinical trial comparing two methods of regional analgesia for primary TKA. All adult primary TKA patients are eligible for inclusion in the study.
Exclusion criteria:
- Allergy to local anesthetics or to systemic opioids
- Contraindication to regional anesthesia technique, such as local infection or coagulopathy
- Sensory/motor disorder involving operative limb
- Requirements of more than 30 mg morphine equivalent daily prior to surgery
- ASA 4 or greater
- Psychiatric or cognitive disorders
- Incarceration
- Renal insufficiency with Cr > 2.0
- Hepatic failure
- Pregnancy
- Age under 18 years Potential risks for the procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity. All are commonly listed as rare complications of the procedures.
After consenting to participation and upon randomization, ACBs will be placed either in the regional anesthesia bay or the OR prior to anesthesia induction and surgery, or in the OR immediately upon completion of surgery.
For participating patients, the following data will be collected by the research staff: ASA physical status, age, height, weight, gender, intra- and post operative quantitative opiate use (expressed as morphine equivalent), numeric VAS scores, KSS score (form included) and QoR score (form included).
Those collecting data will be blinded from randomization of patients to either research group.
Intraoperative care:
Intraoperative anesthesia will be achieved using a general anesthetic technique. Intraoperative analgesia will be administered per anesthesiologists' discretion.
All patients will have cemented total knee utilizing a medial parapatellar approach, including patellar resurfacing. A tourniquet will be used in all cases. Posterior capsule infiltration will be done with 20cc of 0.25% bupivacaine, as the preferred method of providing sacral plexus analgesia 5-6, per current institutional protocol.
ACB Procedure Details Patients will lie in the supine position. The needle insertion site, approximately 10cm proximal to their operative knee, will be exposed. The skin will be disinfected with 2% Chlorhexidine and the ultrasound probe placed in a sterile sleeve. The femoral artery is identified with a high frequency linear transducer (Philips 4-12L linear transducer with a frequency of 6-12 MHz, Milwaukee, WI or ) proximal to the operative knee. The appropriate location for injection will be determined by following the femoral artery cephalad until the artery is directly posterior to the Sartorius muscle. At this level, the saphenous nerve is located lateral to the femoral artery. An 18g insulated sonographic Tuohy needle (Pajunk GmbH, Geisingen, Germany) will be inserted in an in-plane approach, under constant ultrasound visualization, through the Sartorius muscle to a final location in close proximity to the saphenous nerve. Once satisfied with needle placement and following negative aspiration, 20 cc of 0.5% ropivacaine will be injected gradually through the needle under visualization, with recurrent aspirations to verify absence of intra-vascular injection signs.
Data Collection Patients will be enrolled for the study during the orthopedic surgical appointment upon the scheduling of the surgery. Upon enrollment, patients will complete a baseline KSS questionnaire (attached), have a VAS pain score recorded, and have their pre-operative analgesic medication documented.
To assess the effect of pain with movement and overall strength, on POD 1, the patient will indicate their level of pain using VAS numeric scale (1-10). QoR questionnaire (attached) will be assessed 24 hours from the placement of the ACB. Overall analgesic medication consumption, both opioid (expressed as morphine equivalent) and non-opioid will be recorded for PODs 1-3.
The patients will also complete the KSS and the QoR questionnaires at the 4-6 week orthopedic follow-up appointment, as VAS scores and total analgesic medication will be documented.
- Conditions
- Anesthesia, Regional
- Being tested
- 0.5% ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% ropivacaineDrug
Adductor canal block (ACB) performed as part of their analgesic regimen for primary total knee arthroplasty achieved with 20 cc of 0.5% ropivacaine under constant ultrasound visualization.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving ACB before primary TKA | Active comparator | Patients receiving adductor canal block (ACB) before primary total knee arthroplasty (TKA).
Patients randomized to this group will receive the block prior to incision after induction of general anesthesia Receives: Drug: 0.5% ropivacaine |
| Patients receiving ACB after primary TKA | Active comparator | Patients receiving adductor canal block (ACB) immediately after primary total knee arthroplasty (TKA).
Patients randomized to this group will receive the block at the end of the surgery. Receives: Drug: 0.5% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score associated with knee motion following TKA
This study's primary endpoint the change in the patient's reported pain score on the preoperative visit, on postoperative day (POD) 1, and the patient's pain score reported on the 4-6 week follow- up visit. Pain score will be measured using a numeric verbal analogue scale (1-10). Pain will be measured using this scale on the pre-operative visit, and on POD1 prior to manipulation, with active (patient driven) movement and with passive (physician elicited) movement.
Measured: 4-6 Weeks postoperatively
Secondary outcomes (10)
Opioid consumption
This study secondary endpoints is to evaluate changes in opioid consumption throughout 24-48 hours postoperatively to the 4-6 weeks postoperatively.Opioid consumption will be documented by a member of the research team at 24 hours postoperatively, 48 hours postoperatively , and on the follow-up visit (4-6 weeks postoperatively) in order to identify reduction / increases in patient's opioid consumption trends.
Measured: 4-6 weeks postoperatively
Patient satisfaction between the two analgesic approaches.
Additional secondary endpoint of this study is to evaluate whether patient's satisfaction scores differ amongst the two analgesic approaches on the POD 1. Patient's satisfaction score will be measured using the Quality of Recovery (QoR) score, documented on POD 1.
Measured: 24 hours postoperatively
Assessment of postoperative ambulation.
Additional secondary endpoint of this study include assessment of changes in ambulation the range of motion throughout the study participation, from the preoperative visit to the follow-up visit (4-6 weeks following surgery). Knee Society Score (KSS) will be documented on preoperative visit, on POD 1 and at the follow-up visit ( 4-6 weeks after surgery), to examine changes in ambulation.
Measured: 4-6 weeks postoperatively
Assessment of postoperative pain at rest
Additional secondary endpoint of this study include assessment of changes in pain at rest using the KSS score throughout the study participation, from the preoperative visit to the follow-up visit (4-6 weeks following surgery). Knee Society Score (KSS) will be documented on preoperative visit, on POD 1 and at the follow-up visit ( 4-6 weeks after surgery), to examine changes in patients reported pain at rest.
Measured: 4-6 weeks postoperatively
Thrombo-embolic complications
Complications of deep venous thrombosis, pulmonary embolus will be documented
Measured: Up to 24 weeks
Blood transfusion
Additional secondary endpoint of this study is to assess whether the different analgesic approaches effect bleeding complications, measured by the number of patients who receive transfusion of concentrated blood cells units throughout their hospital admission.
Measured: Up to 24 weeks
Non opioid analgesia consumption
This study secondary endpoints is to evaluate changes in non-opioid analgesia -non opioid medication consumption throughout 24-48 hours postoperatively to the 4-6 weeks after surgery. Non-opioid analgesia - non-opioid medication consumption will be recorded on pre-operative visit, on POD 1, and on the follow-up visit (4-6 weeks postoperatively) in order to identify reduction / increases in patient's non-opioid analgesia -non opioid medication consumption trends.
Measured: 4-6 weeks postoperatively
Patient satisfaction with the two analgesic approaches 4-6 weeks postopertively
Additional secondary endpoint of this study is to evaluate whether patient's satisfaction scores differ among the two analgesic approaches at the follow-up visit (4-6 weeks postoperatively). Patient's satisfaction score will be measured using the Quality of Recovery (QoR) score, documented on follow-up visit.
Measured: 4-6 weeks postoperatively
Abnormal hemoglobin concentration values
Additional secondary endpoint of this study is to assess whether the different analgesic approaches effect bleeding complications, measured by the percent of decline in patients' hemoglobin concentration throughout their hospital admission.
Measured: Up to 24 weeks
Duration of hospital stay
Additional secondary endpoint of this study is to assess whether the different analgesic approaches effect duration of hospital admission, measured by the length of stay in the hospital.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, RegionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908711
- Sponsor's protocol ID
- 0524-16-RMC
- Status last verified
- Aug 2016
- First submitted
- 21 Aug 2016
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.
PubMed 18627367O'Donnell BD, Iohom G. Regional anesthesia techniques for ambulatory orthopedic surgery. Curr Opin Anaesthesiol. 2008 Dec;21(6):723-8. doi: 10.1097/aco.0b013e328314b665.
PubMed 19009687Jenstrup 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 22221014Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.
PubMed 23302898Kazak Bengisun Z, Aysu Salviz E, Darcin K, Suer H, Ates Y. Intraarticular levobupivacaine or bupivacaine administration decreases pain scores and provides a better recovery after total knee arthroplasty. J Anesth. 2010 Oct;24(5):694-9. doi: 10.1007/s00540-010-0970-x. Epub 2010 Jun 23.
PubMed 20571832Essving P, Axelsson K, Aberg E, Spannar H, Gupta A, Lundin A. Local infiltration analgesia versus intrathecal morphine for postoperative pain management after total knee arthroplasty: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):926-33. doi: 10.1213/ANE.0b013e3182288deb. Epub 2011 Aug 4.
PubMed 21821506Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.
PubMed 9895071Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PubMed 10740540Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.
PubMed 2805470Melvin JS, Stryker LS, Sierra RJ. Tranexamic Acid in Hip and Knee Arthroplasty. J Am Acad Orthop Surg. 2015 Dec;23(12):732-40. doi: 10.5435/JAAOS-D-14-00223. Epub 2015 Oct 22.
PubMed 26493971Heller S, Shemesh S, Rukinglaz O, Cohen N, Velkes S, Fein S. Efficacy of single-shot adductor canal block before Versus after primary total knee arthroplasty - Does timing make a difference? A randomized controlled trial. J Orthop Surg (Hong Kong). 2022 Sep-Dec;30(3):10225536221132050. doi: 10.1177/10225536221132050.
PubMed 36189733
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Adductor Canal Block (ACB) Before and After Primary Total Knee Arthroplasty (TKA): A Prospective Randomized Trial to Compare Postoperative Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02908711
- Acronym / sponsor ID
- 0524-16-RMC
- Conditions
- Anesthesia, Regional
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 21 Sep 2016 (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.
Total knee arthroplasty (TKA) is associated with severe postoperative pain. Multimodal analgesia, including peripheral nerve block, is recommended for post-operative pain relief 1. Perineural analgesia offers the advantage of extended pain relief up to 24 hours after surgery2.
This is a prospective, randomized control trial designed to compare the analgesic efficacy of the adductor canal block (ACB) performed immediately before or immediately after primary total knee arthroplasty (TKA). The primary objective of this study is to measure pain score associated with knee motion following TKA among patients receiving ACB as part of their analgesic regimen for TKA. Secondary end points include assessment of postoperative ambulation, range of motion, pain at rest, opioid consumption, and patient satisfaction between the two analgesic approaches. The investigators hypothesize that ACB before the surgery will reduce a patient's postoperative pain and improve patient satisfaction.
All consecutive patients undergoing primary TKA will be recruited for enrollment in the study. Patients will be for randomized preoperatively to receive either preemptive ABC (PreACB) or postoperative ABC (PostACB). Patients randomized to the PreACB group will receive the block prior to incision. Patients randomized to the PostACB group will receive the block at the end of the surgery. Both techniques are in accordance to the standard of care at our institute. All patients will have the ACB done by a regional anesthesiologist in the regional anesthesia unit, or in the operating room. Patient medical history will be obtained and blocks will be placed per usual protocol. Operative and anesthetic details, including medications given, will be recorded.
Pain scores and pain medications given in the PACU will be recorded. Supplementary analgesics will be provided per institutional PACU protocol. Study data will be recorded for up to 72 hours or until patient discharge. A follow-up will occur in 4- 6 weeks at the orthopedic follow-up appointment to evaluate the patient's late pain scores and overall satisfaction. Data will be analyzed both at the conclusion of the study and at several intervals prior to completion of the study.
Detailed description
- Research Design and Methods
Inclusion Criteria:
The study is a prospective, randomized controlled clinical trial comparing two methods of regional analgesia for primary TKA. All adult primary TKA patients are eligible for inclusion in the study.
Exclusion criteria:
- Allergy to local anesthetics or to systemic opioids
- Contraindication to regional anesthesia technique, such as local infection or coagulopathy
- Sensory/motor disorder involving operative limb
- Requirements of more than 30 mg morphine equivalent daily prior to surgery
- ASA 4 or greater
- Psychiatric or cognitive disorders
- Incarceration
- Renal insufficiency with Cr > 2.0
- Hepatic failure
- Pregnancy
- Age under 18 years Potential risks for the procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity. All are commonly listed as rare complications of the procedures.
After consenting to participation and upon randomization, ACBs will be placed either in the regional anesthesia bay or the OR prior to anesthesia induction and surgery, or in the OR immediately upon completion of surgery.
For participating patients, the following data will be collected by the research staff: ASA physical status, age, height, weight, gender, intra- and post operative quantitative opiate use (expressed as morphine equivalent), numeric VAS scores, KSS score (form included) and QoR score (form included).
Those collecting data will be blinded from randomization of patients to either research group.
Intraoperative care:
Intraoperative anesthesia will be achieved using a general anesthetic technique. Intraoperative analgesia will be administered per anesthesiologists' discretion.
All patients will have cemented total knee utilizing a medial parapatellar approach, including patellar resurfacing. A tourniquet will be used in all cases. Posterior capsule infiltration will be done with 20cc of 0.25% bupivacaine, as the preferred method of providing sacral plexus analgesia 5-6, per current institutional protocol.
ACB Procedure Details Patients will lie in the supine position. The needle insertion site, approximately 10cm proximal to their operative knee, will be exposed. The skin will be disinfected with 2% Chlorhexidine and the ultrasound probe placed in a sterile sleeve. The femoral artery is identified with a high frequency linear transducer (Philips 4-12L linear transducer with a frequency of 6-12 MHz, Milwaukee, WI or ) proximal to the operative knee. The appropriate location for injection will be determined by following the femoral artery cephalad until the artery is directly posterior to the Sartorius muscle. At this level, the saphenous nerve is located lateral to the femoral artery. An 18g insulated sonographic Tuohy needle (Pajunk GmbH, Geisingen, Germany) will be inserted in an in-plane approach, under constant ultrasound visualization, through the Sartorius muscle to a final location in close proximity to the saphenous nerve. Once satisfied with needle placement and following negative aspiration, 20 cc of 0.5% ropivacaine will be injected gradually through the needle under visualization, with recurrent aspirations to verify absence of intra-vascular injection signs.
Data Collection Patients will be enrolled for the study during the orthopedic surgical appointment upon the scheduling of the surgery. Upon enrollment, patients will complete a baseline KSS questionnaire (attached), have a VAS pain score recorded, and have their pre-operative analgesic medication documented.
To assess the effect of pain with movement and overall strength, on POD 1, the patient will indicate their level of pain using VAS numeric scale (1-10). QoR questionnaire (attached) will be assessed 24 hours from the placement of the ACB. Overall analgesic medication consumption, both opioid (expressed as morphine equivalent) and non-opioid will be recorded for PODs 1-3.
The patients will also complete the KSS and the QoR questionnaires at the 4-6 week orthopedic follow-up appointment, as VAS scores and total analgesic medication will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving ACB before primary TKA | Active comparator | Drug: 0.5% ropivacainePatients receiving adductor canal block (ACB) before primary total knee arthroplasty (TKA). Patients randomized to this group will receive the block prior to incision after induction of general anesthesia |
| Patients receiving ACB after primary TKA | Active comparator | Drug: 0.5% ropivacainePatients receiving adductor canal block (ACB) immediately after primary total knee arthroplasty (TKA). Patients randomized to this group will receive the block at the end of the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study is a prospective, randomized controlled clinical trial comparing two methods of regional analgesia for primary TKA. All adult primary TKA patients are eligible for inclusion in the study.
Key exclusion criteria (11 listed)
- Allergy to local anesthetics or to systemic opioids
- Contraindication to regional anesthesia technique, such as local infection or coagulopathy
- Sensory/motor disorder involving operative limb
- Requirements of more than 30 mg morphine equivalent daily prior to surgery
- ASA 4 or greater
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 |
|---|---|---|
| 0.5% ropivacaineAdductor canal block (ACB) performed as part of their analgesic regimen for primary total knee arthroplasty achieved with 20 cc of 0.5% ropivacaine under constant ultrasound visualization. | Drug | Patients receiving ACB after primary TKA, Patients receiving ACB before primary TKA |
Primary outcome
Pain score associated with knee motion following TKA
Time frame: 4-6 Weeks postoperatively
This study's primary endpoint the change in the patient's reported pain score on the preoperative visit, on postoperative day (POD) 1, and the patient's pain score reported on the 4-6 week follow- up visit. Pain score will be measured using a numeric verbal analogue scale (1-10). Pain will be measured using this scale on the pre-operative visit, and on POD1 prior to manipulation, with active (patient driven) movement and with passive (physician elicited) movement.
10 secondary outcomes
Opioid consumption
Time frame: 4-6 weeks postoperatively
Patient satisfaction between the two analgesic approaches.
Time frame: 24 hours postoperatively
Assessment of postoperative ambulation.
Time frame: 4-6 weeks postoperatively
Assessment of postoperative pain at rest
Time frame: 4-6 weeks postoperatively
Thrombo-embolic complications
Time frame: Up to 24 weeks
Blood transfusion
Time frame: Up to 24 weeks
Non opioid analgesia consumption
Time frame: 4-6 weeks postoperatively
Patient satisfaction with the two analgesic approaches 4-6 weeks postopertively
Time frame: 4-6 weeks postoperatively
Abnormal hemoglobin concentration values
Time frame: Up to 24 weeks
Duration of hospital stay
Time frame: Up to 24 weeks
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 4 Sep 2018.
- Background: PubMed 18627367Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.
- Background: PubMed 19009687O'Donnell BD, Iohom G. Regional anesthesia techniques for ambulatory orthopedic surgery. Curr Opin Anaesthesiol. 2008 Dec;21(6):723-8. doi: 10.1097/aco.0b013e328314b665.
- 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 23302898Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.
- Background: PubMed 20571832Kazak Bengisun Z, Aysu Salviz E, Darcin K, Suer H, Ates Y. Intraarticular levobupivacaine or bupivacaine administration decreases pain scores and provides a better recovery after total knee arthroplasty. J Anesth. 2010 Oct;24(5):694-9. doi: 10.1007/s00540-010-0970-x. Epub 2010 Jun 23.
- Background: PubMed 21821506Essving P, Axelsson K, Aberg E, Spannar H, Gupta A, Lundin A. Local infiltration analgesia versus intrathecal morphine for postoperative pain management after total knee arthroplasty: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):926-33. doi: 10.1213/ANE.0b013e3182288deb. Epub 2011 Aug 4.
- Background: PubMed 9895071Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.
- Background: PubMed 10740540Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
- Background: PubMed 2805470Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.
- Background: PubMed 26493971Melvin JS, Stryker LS, Sierra RJ. Tranexamic Acid in Hip and Knee Arthroplasty. J Am Acad Orthop Surg. 2015 Dec;23(12):732-40. doi: 10.5435/JAAOS-D-14-00223. Epub 2015 Oct 22.
- Derived from this study: PubMed 36189733Heller S, Shemesh S, Rukinglaz O, Cohen N, Velkes S, Fein S. Efficacy of single-shot adductor canal block before Versus after primary total knee arthroplasty - Does timing make a difference? A randomized controlled trial. J Orthop Surg (Hong Kong). 2022 Sep-Dec;30(3):10225536221132050. doi: 10.1177/10225536221132050.
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Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
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 4 study testing 0.5% ropivacaine in people with Anesthesia, Regional, run by Rabin Medical Center at 1 site in Israel.
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 1 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 4 Sep 2018. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score associated with knee motion following TKA (time frame: 4-6 Weeks postoperatively). 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 NCT02908711, which also lists 11 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 2018.