Pain ManagementNCT02853669
Adductor Canal Block Versus Lumbar Plexus Block for Post Operative Pain Management After Total Knee Replacement
A study testing Ultrasound-guided Lumber Plexus Block and adductor canal block in people with Pain Management, run by Cairo University at 1 site in Egypt.
Trial summary
Adductor canal block (ACB), Saphenous nerve block, which is a block of a purely sensory nerve which shares in nerve supply of knee joint has a hypothetical advantage of better pain management with less motor affection. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Ultrasound-guided Lumber Plexus Block and adductor canal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- Age more than 25 and less than 80 were included
Who cannot join
- Patients with known allergy to the medications to be given
- ASA III, IV
- Age less than 25 or more than 80
- Dementia
- Deafness
- Psychological disease
Show all 10Show fewer
- Difficult to communicate
- Cannot lay flat
- INR more than 1.5
- Low platelets (less than 100000/ml3) or with significant coagulopathy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Giza Governorate, 1234
HASSAN M ALI, LECTURER, +201001733687, hassan364@hotmail.com
About this study
Adductor canal block (ACB), Saphenous nerve block, which is a block of a purely sensory nerve which shares in nerve supply of knee joint has a hypothetical advantage of better pain management with less motor affection. Also, it has a clear anatomical landmark that will increase the success rate (femoral artery) (*).On the other hand, being a branch of the femoral nerve and far distal from the plexus, this can decrease the blocking effectiveness. Likewise, the great variation of the knee nerve supply.
This prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy.
This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.
Read the detailed description
This prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy.
This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.
- Conditions
- Pain Management
- Being tested
- Ultrasound-guided Lumber Plexus Block, adductor canal block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Lumber Plexus BlockProcedure or surgery
(30 cc of 0.25% of bupivacaine, via a 22-gauge 2-inch Stimuplex A needle) with nerve stimulator confirmation. The type of motor response (e.g., quadriceps, patellar) and the minimum current needed were recorded. Ultrasound pictures (preinjection and postinjection) were obtained to verify proper local anesthetic placement.
adductor canal blockProcedure or surgery
Also called saphenous nerve block
ultrasound-guided Adductor Canal Block (15 cc of 0.5% of bupivacaine)
| Study group | Role | What they receive |
|---|---|---|
| group (A) lumber plexus block | Experimental | Ultrasound-guided Lumber plexus Block (30 cc of 0.25% of bupivacaine, via a 22-gauge 2-inch Stimuplex A needle) with nerve stimulator confirmation. Receives: Procedure: Ultrasound-guided Lumber Plexus Block |
| Group (B) adductor canal block | Experimental | ultrasound-guided Adductor Canal Block (15 cc of 0.5% of bupivacaine) Receives: Procedure: adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
pain assessment using visual analogue scale
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Ali, Cairo University
- Investigators
- Hassan Ali, LECTURER, Study director, Anesthesia department, faculty of medicine ,Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853669
- Sponsor's protocol ID
- adductor canal
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block Versus Lumbar Plexus Block for Post Operative Pain Management After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT02853669
- Acronym / sponsor ID
- adductor canal
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 3 Aug 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.
Adductor canal block (ACB), Saphenous nerve block, which is a block of a purely sensory nerve which shares in nerve supply of knee joint has a hypothetical advantage of better pain management with less motor affection. Also, it has a clear anatomical landmark that will increase the success rate (femoral artery) (*).On the other hand, being a branch of the femoral nerve and far distal from the plexus, this can decrease the blocking effectiveness. Likewise, the great variation of the knee nerve supply.
This prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy.
This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.
Detailed description
This prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy.
This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group (A) lumber plexus block | Experimental | Procedure: Ultrasound-guided Lumber Plexus BlockUltrasound-guided Lumber plexus Block (30 cc of 0.25% of bupivacaine, via a 22-gauge 2-inch Stimuplex A needle) with nerve stimulator confirmation. |
| Group (B) adductor canal block | Experimental | Procedure: adductor canal blockultrasound-guided Adductor Canal Block (15 cc of 0.5% of bupivacaine) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II
- Age more than 25 and less than 80 were included
Key exclusion criteria (10 listed)
- Patients with known allergy to the medications to be given
- ASA III, IV
- Age less than 25 or more than 80
- Dementia
- Deafness
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 |
|---|---|---|
| Ultrasound-guided Lumber Plexus Block(30 cc of 0.25% of bupivacaine, via a 22-gauge 2-inch Stimuplex A needle) with nerve stimulator confirmation. The type of motor response (e.g., quadriceps, patellar) and the minimum current needed were recorded. Ultrasound pictures (preinjection and postinjection) were obtained to verify proper local anesthetic placement. | Procedure or surgery | group (A) lumber plexus block |
| adductor canal blockAlso: saphenous nerve blockultrasound-guided Adductor Canal Block (15 cc of 0.5% of bupivacaine) | Procedure or surgery | Group (B) adductor canal block |
Primary outcome
pain
Time frame: 2 hours
pain assessment using visual analogue scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
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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.
Hassan Ali, LECTURER study director
Anesthesia department, faculty of medicine ,Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Lumber Plexus Block and adductor canal block in people with Pain Management, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 10 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 3 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 Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan Ali, lecturer (1001733687, hassan364@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.