Postoperative PainNCT04443634
Adductor Canal Block (ACB) Versus ACB /Saphenous Block in Patients Undergoing Anterior Cruciate Ligament Repair
A study testing Ultrasound Guided Adductor Canal Block, Ultrasound Guided Saphenous Nerve Block and General anesthesia in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Knee surgeries are associated with severe postoperative pain. Blocking the femoral nerve (or saphenous nerve) in the adductor canal is increasingly used for knee analgesia. It carries potential benefits that encourage anesthesiologists to do it. It has a motor sparing property. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ultrasound Guided Adductor Canal Block, Ultrasound Guided Saphenous Nerve Block and General anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2020to 1 Oct 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for knee orthopedic ( ACL repair)
- Physical status ASA I, II.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Who cannot join
- • Patients with known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- Infection of the skin at the site of needle puncture area.
- Patient refusal.
- Severe respiratory or cardiac disorders.
Show all 9Show fewer
- Advanced liver or kidney disease.
- Pregnancy.
- Patient with surgery duration more than two hours.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Anesthesia Department
Cairo
Bassant abdelhamid, 01224254012, bassantmohamed197@yahoo.com
About this study
Official title: Presurgical Adductor Canal Block (ACB) Versus ACB and Distal (Intermuscular) Saphenous Nerve Block in Patients Undergoing Anterior Cruciate Ligament Repair Under General Anaesthesia: Randomised Controlled Trial.
Knee surgeries are associated with severe postoperative pain. Blocking the femoral nerve (or saphenous nerve) in the adductor canal is increasingly used for knee analgesia. It carries potential benefits that encourage anesthesiologists to do it. It has a motor sparing property. Injection of local anesthetics in this lengthy canal that contains a variable amount of connective or fibrous tissue might lead to a patchy distribution of local anesthetics. Thus, the possibility of incomplete block of the saphenous nerve (most important nerve in knee innervations) cannot be excluded.
Read the detailed description
Aim of the study is to compare the efficacy of the adductor canal block to the combined adductor canal block and saphenous nerve block at the distal third of thigh in the intermuscular plane between Vastus Medialis and Sartorius muscles in pain relief following knee arthroscopic anterior cruciate ligament repair.
After written informed consent, patients will be randomized in three groups:
Group (Adductor 20): Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivcaine 0.5%.
Group (Adductor 30) Ultrasound guided adductor canal block will be performed with injection of 30 ml bupivacaine 0.5%. Group (Adductor/saphenous ): Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine 0.5%, combined with ultrasound guided saphenous
- Conditions
- Postoperative Pain
- Being tested
- Ultrasound Guided Adductor Canal Block, Ultrasound Guided Saphenous Nerve Block, General anesthesia, Bupivacaine 20 ml, Bupivacaine 30ml
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Adductor Canal BlockProcedure or surgery
It will be performed at the midthigh level, approximately halfway between the superior anterior iliac spine and the patella, a high-frequency linear ultrasound (US) transducer 5-12 MHz probe. Underneath the sartorius muscle the femoral artery was identified, with the vein just inferior and the saphenous nerve just lateral to the artery. From the lateral side of the transducer a 10-cm, 18-gauge Tuohy needle (Braun Medical, Melsungen, Germany) was inserted in plane, through the Sartorius muscle. With the tip of the Tuohy needle placed just underneath the vasto-adductor membrane and lateral to the artery and the saphenous nerve, 20 ml local anesthetic mixture will be injected to expand the adductor canal. the volume of local anesthetic will be selected according to the studied group
Ultrasound Guided Saphenous Nerve BlockProcedure or surgery
It will be performed at the intermuscular plane between the sartorius and the vasus medialis muscles at the lower third of the thigh.
The US probe will be positioned on the front of the lower part of the thigh immediately above the patella to see both the patella (hyperechoic curved line) and vastus medialis infront of it (closer to skin). The probe is then moved medially over the vastus medialis till we see the end of the muscle and we see an intermuscular plane between it and Sartorius muscle. A 20 guage spinal needle will be then passed in an in plane direction within the substance of vastus medialis muscle and then pass within the vastus medialis until it faces the intermuscular plane between VM muscle and Sartorius. Once the needle tip is located in close proximity to the target structures, gentle aspiration will be performed followed by 20 ml local anesthetic will be injected.
General anesthesiaProcedure or surgery
General anesthesia was induced by propofol 1-2 mg/kg fentanyle 100micg and laryngeal mask was inserted. Maintanace of anesthesia was performed by sevoflurane 2-3%.
Then the surgical procedure started. All patients had arthroscopic knee surgery( ACL repair) surgery under tourniquet control.
Immediately after end the surgical procedure, either ACB or combined ACB and saphenous nerve block distal to adductor canal were performed according to randomization.
Bupivacaine 20 mlDrug
20ml bupivacaine 0.5%
Bupivacaine 30mlDrug
30ml bupivacaine 0.5%
Bupivacaine 10mlDrug
10ml bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Adductor 20 | Experimental | Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine Receives: Procedure: Ultrasound Guided Adductor Canal Block; Procedure: General anesthesia; Drug: Bupivacaine 20 ml |
| Adductor 30 | Experimental | Ultrasound guided adductor canal block will be performed with injection of 30ml bupivacaine Receives: Procedure: Ultrasound Guided Adductor Canal Block; Procedure: General anesthesia; Drug: Bupivacaine 30ml |
| Adductor /Saphenous | Experimental | Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine , combined with ultrasound guided saphenous nerve block at the distal third of the thigh in the intermuscular plane between Vastus Medialis and Sartorius muscle with injection of 10ml bupivacaine 0.5%. Receives: Procedure: Ultrasound Guided Adductor Canal Block; Procedure: Ultrasound Guided Saphenous Nerve Block; Procedure: General anesthesia; Drug: Bupivacaine 20 ml; Drug: Bupivacaine 10ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of morphine consumption in the first 24 hours postoperatively.
The total amount of morphine consumption in the first 24 hours postoperatively.
Measured: 24 hours postoperative
Secondary outcomes (4)
Total dose of intraoperative fentanyle adminstration
Measured: 2 hours intraoperatively
Numeric Pain Rating Scale
Numeric Pain Rating Scale, both at rest and during movement: 30 minutes,2, 4,6, 8, 12, 16, 20 and 24 hours postoperatively. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
Measured: 24 hours postoperative
Failure rate of the block
- Failure rate of the block will be calculated, where the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.
Measured: 24 hours
Block related complications
- The incidence of vascular puncture, and presence or absence of saphenous nerve neuritis during the first month after surgery were also recorded
Measured: 1 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start25 Jun 2020
- Primary completion25 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Bassant abdelhamid, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443634
- Sponsor's protocol ID
- N-27-2017
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
PubMed 20889937Ilfeld BM, Moeller LK, Mariano ER, Loland VJ, Stevens-Lapsley JE, Fleisher AS, Girard PJ, Donohue MC, Ferguson EJ, Ball ST. Continuous peripheral nerve blocks: is local anesthetic dose the only factor, or do concentration and volume influence infusion effects as well? Anesthesiology. 2010 Feb;112(2):347-54. doi: 10.1097/ALN.0b013e3181ca4e5d.
PubMed 20098137Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.
PubMed 25386752Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
PubMed 19916251
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presurgical Adductor Canal Block (ACB) Versus ACB and Distal (Intermuscular) Saphenous Nerve Block in Patients Undergoing Anterior Cruciate Ligament Repair Under General Anaesthesia: Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04443634
- Acronym / sponsor ID
- N-27-2017
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 25 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 23 Jun 2020 (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.
Knee surgeries are associated with severe postoperative pain. Blocking the femoral nerve (or saphenous nerve) in the adductor canal is increasingly used for knee analgesia. It carries potential benefits that encourage anesthesiologists to do it. It has a motor sparing property. Injection of local anesthetics in this lengthy canal that contains a variable amount of connective or fibrous tissue might lead to a patchy distribution of local anesthetics. Thus, the possibility of incomplete block of the saphenous nerve (most important nerve in knee innervations) cannot be excluded.
Detailed description
Aim of the study is to compare the efficacy of the adductor canal block to the combined adductor canal block and saphenous nerve block at the distal third of thigh in the intermuscular plane between Vastus Medialis and Sartorius muscles in pain relief following knee arthroscopic anterior cruciate ligament repair.
After written informed consent, patients will be randomized in three groups:
Group (Adductor 20): Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivcaine 0.5%.
Group (Adductor 30) Ultrasound guided adductor canal block will be performed with injection of 30 ml bupivacaine 0.5%. Group (Adductor/saphenous ): Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine 0.5%, combined with ultrasound guided saphenous
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adductor 20 | Experimental | Procedure: Ultrasound Guided Adductor Canal Block, Procedure: General anesthesia, Drug: Bupivacaine 20 mlUltrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine |
| Adductor 30 | Experimental | Procedure: Ultrasound Guided Adductor Canal Block, Procedure: General anesthesia, Drug: Bupivacaine 30mlUltrasound guided adductor canal block will be performed with injection of 30ml bupivacaine |
| Adductor /Saphenous | Experimental | Procedure: Ultrasound Guided Adductor Canal Block, Procedure: Ultrasound Guided Saphenous Nerve Block, Procedure: General anesthesia, Drug: Bupivacaine 20 ml, Drug: Bupivacaine 10mlUltrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine , combined with ultrasound guided saphenous nerve block at the distal third of the thigh in the intermuscular plane between Vastus Medialis and Sartorius muscle with injection of 10ml bupivacaine 0.5%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for knee orthopedic ( ACL repair)
- Physical status ASA I, II.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Key exclusion criteria (9 listed)
- • Patients with known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
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 Adductor Canal BlockIt will be performed at the midthigh level, approximately halfway between the superior anterior iliac spine and the patella, a high-frequency linear ultrasound (US) transducer 5-12 MHz probe. Underneath the sartorius muscle the femoral artery was identified, with the vein just inferior and the saphenous nerve just lateral to the artery. From the lateral side of the transducer a 10-cm, 18-gauge Tuohy needle (Braun Medical, Melsungen, Germany) was inserted in plane, through the Sartorius muscle. With the tip of the Tuohy needle placed just underneath the vasto-adductor membrane and lateral to the artery and the saphenous nerve, 20 ml local anesthetic mixture will be injected to expand the adductor canal. the volume of local anesthetic will be selected according to the studied group | Procedure or surgery | Adductor /Saphenous, Adductor 20, Adductor 30 |
| Ultrasound Guided Saphenous Nerve BlockIt will be performed at the intermuscular plane between the sartorius and the vasus medialis muscles at the lower third of the thigh. The US probe will be positioned on the front of the lower part of the thigh immediately above the patella to see both the patella (hyperechoic curved line) and vastus medialis infront of it (closer to skin). The probe is then moved medially over the vastus medialis till we see the end of the muscle and we see an intermuscular plane between it and Sartorius muscle. A 20 guage spinal needle will be then passed in an in plane direction within the substance of vastus medialis muscle and then pass within the vastus medialis until it faces the intermuscular plane between VM muscle and Sartorius. Once the needle tip is located in close proximity to the target structures, gentle aspiration will be performed followed by 20 ml local anesthetic will be injected. | Procedure or surgery | Adductor /Saphenous |
| General anesthesiaGeneral anesthesia was induced by propofol 1-2 mg/kg fentanyle 100micg and laryngeal mask was inserted. Maintanace of anesthesia was performed by sevoflurane 2-3%. Then the surgical procedure started. All patients had arthroscopic knee surgery( ACL repair) surgery under tourniquet control. Immediately after end the surgical procedure, either ACB or combined ACB and saphenous nerve block distal to adductor canal were performed according to randomization. | Procedure or surgery | Adductor /Saphenous, Adductor 20, Adductor 30 |
| Bupivacaine 20 ml20ml bupivacaine 0.5% | Drug | Adductor /Saphenous, Adductor 20 |
| Bupivacaine 30ml30ml bupivacaine 0.5% | Drug | Adductor 30 |
| Bupivacaine 10ml10ml bupivacaine 0.5% | Drug | Adductor /Saphenous |
Primary outcome
The total dose of morphine consumption in the first 24 hours postoperatively.
Time frame: 24 hours postoperative
The total amount of morphine consumption in the first 24 hours postoperatively.
4 secondary outcomes
Total dose of intraoperative fentanyle adminstration
Time frame: 2 hours intraoperatively
Numeric Pain Rating Scale
Time frame: 24 hours postoperative
Failure rate of the block
Time frame: 24 hours
Block related complications
Time frame: 1 mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Background: PubMed 20889937Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
- Background: PubMed 20098137Ilfeld BM, Moeller LK, Mariano ER, Loland VJ, Stevens-Lapsley JE, Fleisher AS, Girard PJ, Donohue MC, Ferguson EJ, Ball ST. Continuous peripheral nerve blocks: is local anesthetic dose the only factor, or do concentration and volume influence infusion effects as well? Anesthesiology. 2010 Feb;112(2):347-54. doi: 10.1097/ALN.0b013e3181ca4e5d.
- Background: PubMed 25386752Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.
- Background: PubMed 19916251Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassant abdelhamid principal investigator
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 Adductor Canal Block, Ultrasound Guided Saphenous Nerve Block and General anesthesia in people with Postoperative Pain, 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 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2020. 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 Bassant abdelhamid, M.D. (01224254012, bassantmohamed197@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total dose of morphine consumption in the first 24 hours postoperatively. (time frame: 24 hours postoperative). 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 NCT04443634, which also lists 4 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 29 Jun 2020.