AnalgesiaPhase 4NCT05715437
Adductor Canal Block in Total Knee Arthroplasty
A Phase 4 study testing Bupivacaine plus Normal Saline and Bupivacain and ketamine in people with Analgesia, run by Assiut University.
Trial summary
The purpose of this study is to evaluate whether adding ketamine to bupivacaine is superior to bupivacaine alone in terms of providing better pain control for 48 hours postoperatively after TKA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Bupivacaine plus Normal Saline and Bupivacain and ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is scheduled for elective primary unilateral TKA.
- The subject is ≥ 18 years and ≤ 80 years.
- Both sexes.
- The subject's primary anesthesia care team has planned for a spinal anesthesia.
- The patient agrees to receive an adductor canal block.
- ASA class 1-3.
Who cannot join
- Subject is < 18 years of age or >80 years of age.
- Subject is known or believed to be pregnant.
- Significant pre-existing neuropathy on the operative limb.
- Significant renal, cardiac or hepatic disease.
- ASA class 4-5.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analgesic Efficacy of Adductor Canal Block With Bupivacaine Versus Bupivacaine and Ketamine in Total Knee Arthroplasty.
The purpose of this study is to evaluate whether adding ketamine to bupivacaine is superior to bupivacaine alone in terms of providing better pain control for 48 hours postoperatively after TKA.
Read the detailed description
Optimal pain relief is essential for functional recovery after total knee arthroplasty (TKA). Addition of femoral nerve block (FNB) to an analgesic regimen provides superior pain control and shortens hospital stay, in comparison with epidural or intravenous patient-controlled analgesia (PCA) alone. However, prolonged motor blockade from FNB is associated with a small (2%) but clinically important risk of fall. With FNB there will always be a compromise between the goals of adequate pain relief and muscle strength. An ideal nerve block would provide effective analgesia, minimize opioid use and side effects, and hasten mobilization by preserving motor strength. "Fast-track" total joint replacements are gaining popularity. Motor preservation with adequate analgesia has become the optimal postoperative pain goal in orthopedic surgeries to enable earlier physical therapy, faster recovery, and shorter hospital stays.Nerve blocks such as femoral nerve block, adductor canal block, and epidural block have been more prevalent in TKA postoperative analgesia due to their effectiveness, easy manipulation, and low rate of complications. Local anesthetics such as ropivacaine or bupivacaine have been commonly used in nerve blocks. However, the postoperative analgesic effects and duration of local anesthetics are not good enough, and sometimes have led to delayed ambulation and an increased risk of falling after TKA. To overcome these shortcomings and further improve the analgesic effect, additional endeavors should be devoted to exploring new and effective agents for nerve block.With the advent of ultrasonography, the adductor canal can be easily visualized at the mid-thigh level, allowing performance of adductor canal block (ACB) with a high success rate. In recent years, ACB has been successfully used for postoperative pain control after knee surgery. Anatomical study of the adductor canal demonstrated that the adductor canal may serve as a conduit for more than just the saphenous nerve, possibly including the vastus medialis nerve, medial femoral cutaneous nerve, articular branches from the obturator nerve, as well as the medial retinacular nerve. Thus, the sensory changes are not limited to the distribution of the saphenous nerve, but includes the medial and anterior aspects of the knee from the superior pole of the patella to the proximal tibia.
- Conditions
- Analgesia
- Being tested
- Bupivacaine plus Normal Saline, Bupivacain and ketamine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine plus Normal SalineDrug
Effect of Bupivacain and ketamine and is superior to Bupivacaine and Normal Saline in terms of providing better pain control for 48 hours postoperatively after TKA.
Bupivacain and ketamineDrug
Effect of Bupivacain and ketamine and is superior to Bupivacaine and Normal Saline in terms of providing better pain control for 48 hours postoperatively after TKA.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine plus Normal Saline | Experimental | 30 patients will receive bolus shot 20ml of 0.5% of Bupivacaine plus 1ml Normal saline postoperative TKA. Receives: Drug: Bupivacaine plus Normal Saline |
| Bupivacaine and Ketamine | Experimental | 30 patients will receive bolus shot 20ml of 0.5% of Bupivacaine plus 1ml ketamine (50mg) postoperative TKA. Receives: Drug: Bupivacain and ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Maximum postoperative pain assessment by the visual analogue scale (VAS) pain scores in the first 48 hours.
Measured: 48 hours
Secondary outcomes (4)
analgesia
VAS pain scores when the knee joint was bent to 45°. At 4 ,8,12,24,36 and 48 hours.
Measured: 48 hours
Analysis include quadriceps strength
quadriceps strength, each of which were assessed at 4, 24, and 48 hours after the operation. The following 5-grade scale was used to quantify quadriceps strength: 1=could not contract; 2=could contract, but the contraction could not cause the knee joint to move; 3=could bear gravity, but could not bear any substantial resistance; 4=could bear substantial resistance; 5=could bear full resistance.
Measured: 48 hours
Satisfaction of the patients
measured using "Likert scale" was acceptable (very satisfied, satisfied, neutral)
Measured: 48 hours
Reporting side effects of drugs given
Side effects of Ketamine: tachycardia, increase blood pressure , allergic reaction, confusion , delirium , hallucination and nightmares.
Side effects of Bupivacaine: chest pain and discomfort, difficult breathing, muscle stiffness, abnormal heart rhythms, numbness or tingling around your mouth, and allergic reaction.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab William Samir, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715437
- Sponsor's protocol ID
- Adductor canal block
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
PubMed 10422923Allen 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 9661553Hadzic A, Houle TT, Capdevila X, Ilfeld BM. Femoral nerve block for analgesia in patients having knee arthroplasty. Anesthesiology. 2010 Nov;113(5):1014-5. doi: 10.1097/ALN.0b013e3181f4b43d. No abstract available.
PubMed 20881593Wang H, Boctor B, Verner J. The effect of single-injection femoral nerve block on rehabilitation and length of hospital stay after total knee replacement. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):139-44. doi: 10.1053/rapm.2002.29253.
PubMed 11915059Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
PubMed 9661552YaDeau JT, Cahill JB, Zawadsky MW, Sharrock NE, Bottner F, Morelli CM, Kahn RL, Sculco TP. The effects of femoral nerve blockade in conjunction with epidural analgesia after total knee arthroplasty. Anesth Analg. 2005 Sep;101(3):891-895. doi: 10.1213/01.ANE.0000159150.79908.21.
PubMed 16116010
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Adductor Canal Block With Bupivacaine Versus Bupivacaine and Ketamine in Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT05715437
- Acronym / sponsor ID
- Adductor canal block
- Conditions
- Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether adding ketamine to bupivacaine is superior to bupivacaine alone in terms of providing better pain control for 48 hours postoperatively after TKA.
Detailed description
Optimal pain relief is essential for functional recovery after total knee arthroplasty (TKA). Addition of femoral nerve block (FNB) to an analgesic regimen provides superior pain control and shortens hospital stay, in comparison with epidural or intravenous patient-controlled analgesia (PCA) alone. However, prolonged motor blockade from FNB is associated with a small (2%) but clinically important risk of fall. With FNB there will always be a compromise between the goals of adequate pain relief and muscle strength. An ideal nerve block would provide effective analgesia, minimize opioid use and side effects, and hasten mobilization by preserving motor strength. "Fast-track" total joint replacements are gaining popularity. Motor preservation with adequate analgesia has become the optimal postoperative pain goal in orthopedic surgeries to enable earlier physical therapy, faster recovery, and shorter hospital stays.Nerve blocks such as femoral nerve block, adductor canal block, and epidural block have been more prevalent in TKA postoperative analgesia due to their effectiveness, easy manipulation, and low rate of complications. Local anesthetics such as ropivacaine or bupivacaine have been commonly used in nerve blocks. However, the postoperative analgesic effects and duration of local anesthetics are not good enough, and sometimes have led to delayed ambulation and an increased risk of falling after TKA. To overcome these shortcomings and further improve the analgesic effect, additional endeavors should be devoted to exploring new and effective agents for nerve block.With the advent of ultrasonography, the adductor canal can be easily visualized at the mid-thigh level, allowing performance of adductor canal block (ACB) with a high success rate. In recent years, ACB has been successfully used for postoperative pain control after knee surgery. Anatomical study of the adductor canal demonstrated that the adductor canal may serve as a conduit for more than just the saphenous nerve, possibly including the vastus medialis nerve, medial femoral cutaneous nerve, articular branches from the obturator nerve, as well as the medial retinacular nerve. Thus, the sensory changes are not limited to the distribution of the saphenous nerve, but includes the medial and anterior aspects of the knee from the superior pole of the patella to the proximal tibia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine plus Normal Saline | Experimental | Drug: Bupivacaine plus Normal Saline30 patients will receive bolus shot 20ml of 0.5% of Bupivacaine plus 1ml Normal saline postoperative TKA. |
| Bupivacaine and Ketamine | Experimental | Drug: Bupivacain and ketamine30 patients will receive bolus shot 20ml of 0.5% of Bupivacaine plus 1ml ketamine (50mg) postoperative TKA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is scheduled for elective primary unilateral TKA.
- The subject is ≥ 18 years and ≤ 80 years.
- Both sexes.
- The subject's primary anesthesia care team has planned for a spinal anesthesia.
- The patient agrees to receive an adductor canal block.
Key exclusion criteria (5 listed)
- Subject is < 18 years of age or >80 years of age.
- Subject is known or believed to be pregnant.
- Significant pre-existing neuropathy on the operative limb.
- Significant renal, cardiac or hepatic disease.
- ASA class 4-5.
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 |
|---|---|---|
| Bupivacaine plus Normal SalineEffect of Bupivacain and ketamine and is superior to Bupivacaine and Normal Saline in terms of providing better pain control for 48 hours postoperatively after TKA. | Drug | Bupivacaine plus Normal Saline |
| Bupivacain and ketamineEffect of Bupivacain and ketamine and is superior to Bupivacaine and Normal Saline in terms of providing better pain control for 48 hours postoperatively after TKA. | Drug | Bupivacaine and Ketamine |
Primary outcome
Visual analogue scale (VAS)
Time frame: 48 hours
Maximum postoperative pain assessment by the visual analogue scale (VAS) pain scores in the first 48 hours.
4 secondary outcomes
analgesia
Time frame: 48 hours
Analysis include quadriceps strength
Time frame: 48 hours
Satisfaction of the patients
Time frame: 48 hours
Reporting side effects of drugs given
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 10422923Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- 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 20881593Hadzic A, Houle TT, Capdevila X, Ilfeld BM. Femoral nerve block for analgesia in patients having knee arthroplasty. Anesthesiology. 2010 Nov;113(5):1014-5. doi: 10.1097/ALN.0b013e3181f4b43d. No abstract available.
- Background: PubMed 11915059Wang H, Boctor B, Verner J. The effect of single-injection femoral nerve block on rehabilitation and length of hospital stay after total knee replacement. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):139-44. doi: 10.1053/rapm.2002.29253.
- Background: PubMed 9661552Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
- Background: PubMed 16116010YaDeau JT, Cahill JB, Zawadsky MW, Sharrock NE, Bottner F, Morelli CM, Kahn RL, Sculco TP. The effects of femoral nerve blockade in conjunction with epidural analgesia after total knee arthroplasty. Anesth Analg. 2005 Sep;101(3):891-895. doi: 10.1213/01.ANE.0000159150.79908.21.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine plus Normal Saline and Bupivacain and ketamine in people with Analgesia, run by Assiut University.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehab Samir, MD (01003078676, hobasamir12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: 48 hours). 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 NCT05715437, which also lists 6 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 8 Feb 2023.