ArthroscopyNCT05269095
Adductor Canal Block Combined With IPACK vs Genicular Nerves Block in Knee Arthroscopy
A study testing Spinal anesthesia only, Spinal anesthesia and ultrasound-guided Genicular nerves block and Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK) in people with Arthroscopy and Genicular Nerves Block, run by Tanta University.
Trial summary
This prospective randomized controlled study is designed to investigate the postoperative analgesic effect of adductor canal block (ACB) combined with infiltration of the interspace between the popliteal artery and the capsule of posterior knee (IPACK) block compared to genicular nerves block in patients undergoing… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Arthroscopy, Genicular Nerves Block
- What is being tested?
- Spinal anesthesia only, Spinal anesthesia and ultrasound-guided Genicular nerves block and Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2022to 21 Mar 2023
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21-60 years
- Both genders
- American Society of Anaesthesiologists physical status classification I - III
- Patients scheduled for elective unilateral knee arthroscopy under spinal anesthesia
Who cannot join
- Patient refusal
- Preoperative neurological deficits
- Opioid-dependent (opioid intake more than 3 months)
- Chronic pain conditions
- Significant cardiac and respiratory disease
- Pre-existing major organ dysfunction such as hepatic and renal failure
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- Coexisting hematological disorder or deranged coagulation parameters
- Psychiatric illnesses
- Allergy to any of the drugs used in the study
About this study
Official title: Analgesic Effect of Adductor Canal Block Combined With Infiltration of the Interspace Between Popliteal Artery and the Capsule of the Knee (IPACK) Block Versus Genicular Nerves Block in Knee Arthroscopy
This prospective randomized controlled study is designed to investigate the postoperative analgesic effect of adductor canal block (ACB) combined with infiltration of the interspace between the popliteal artery and the capsule of posterior knee (IPACK) block compared to genicular nerves block in patients undergoing knee arthroscopy.
Read the detailed description
Maintaining patient safety, ensuring best patient outcomes, and optimal pain relief post-operatively are of utmost concern for anesthesia providers. Adequate pain relief attenuates stress responses and long-term chronic pain complications while contributing to improved postoperative outcomes.
Knee arthroscopy is a very common procedure and very often is performed as day-case surgery. Ambulatory arthroscopic surgery of the knee is preferred by the majority of properly selected and well-informed patients. It has been reported that a significant number of patients have moderate to severe pain 24 hours after ambulatory surgery in general and knee arthroscopy in particular and pain affects the patient's activity level and satisfaction. Adductor canal block (ACB) is a popular peripheral nerve block that has been shown to decrease the pain significantly and decrease opioid consumption with minimal effect on quadriceps function. It provides analgesia to the peri-articular and intra-articular aspects of the knee joint but doesn't relieve posterior knee pain which is moderate to severe in intensity.
- Conditions
- Arthroscopy, Genicular Nerves Block
- Being tested
- Spinal anesthesia only, Spinal anesthesia and ultrasound-guided Genicular nerves block, Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia onlyProcedure or surgery
Patients will receive spinal anesthesia with 2-3 ml 0.5% (10-15 mg) hyperbaric bupivacaine plus 25 ug fentanyl at the L3/4 interspaces.
Spinal anesthesia and ultrasound-guided Genicular nerves blockBiological
Patients will receive16 ml bupivacaine 0025% will be administered, and4 ml of this solution will be placed at each of the 4 target nerves.
Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK)Biological
Adductor Canal block (ACB) technique will be performed using 16 ml bupivacaine 0025% As regarding the Popliteal artery and the capsule of posterior knee block ('PACK), it will be performed Using 16 ml bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia only | Experimental | Patients will receive spinal anesthesia only Receives: Procedure: Spinal anesthesia only |
| spinal anesthesia and ultrasound-guided Genicular nerves block | Experimental | Patients will receive spinal anesthesia and ultrasound-guided Genicular nerves block Receives: Biological: Spinal anesthesia and ultrasound-guided Genicular nerves block |
| Spinal anesthesia and US guided Adductor canal nerve block plus infiltration of the interspace | Experimental | Patients will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block plus infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (PACK) block. Receives: Biological: Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 24-hour rescue analgesic consumption
Total postoperative 24-hour rescue analgesic consumption will be recorded
Measured: 24 hours postoperative
Secondary outcomes (2)
Post-operative pain
Post-operative pain will be assessed by the Numeric Rating Scale (NRS) rest and mobilization.
Measured: 24 hours Postoperative
Time taken till 1st rescue analgesic request
The time till administration of first rescue analgesia will be recorded
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start21 Mar 2022 (estimated)
- Primary completion20 Mar 2023 (estimated)
- Study completion21 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroscopyStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ahmed Kandil, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269095
- Sponsor's protocol ID
- 35236/1/22
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available under a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Adductor Canal Block Combined With Infiltration of the Interspace Between Popliteal Artery and the Capsule of the Knee (IPACK) Block Versus Genicular Nerves Block in Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT05269095
- Acronym / sponsor ID
- 35236/1/22
- Conditions
- Arthroscopy, Genicular Nerves Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 21 Mar 2022 (estimated)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 21 Mar 2023 (estimated)
- First posted
- 7 Mar 2022 (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.
This prospective randomized controlled study is designed to investigate the postoperative analgesic effect of adductor canal block (ACB) combined with infiltration of the interspace between the popliteal artery and the capsule of posterior knee (IPACK) block compared to genicular nerves block in patients undergoing knee arthroscopy.
Detailed description
Maintaining patient safety, ensuring best patient outcomes, and optimal pain relief post-operatively are of utmost concern for anesthesia providers. Adequate pain relief attenuates stress responses and long-term chronic pain complications while contributing to improved postoperative outcomes.
Knee arthroscopy is a very common procedure and very often is performed as day-case surgery. Ambulatory arthroscopic surgery of the knee is preferred by the majority of properly selected and well-informed patients. It has been reported that a significant number of patients have moderate to severe pain 24 hours after ambulatory surgery in general and knee arthroscopy in particular and pain affects the patient's activity level and satisfaction. Adductor canal block (ACB) is a popular peripheral nerve block that has been shown to decrease the pain significantly and decrease opioid consumption with minimal effect on quadriceps function. It provides analgesia to the peri-articular and intra-articular aspects of the knee joint but doesn't relieve posterior knee pain which is moderate to severe in intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia only | Experimental | Procedure: Spinal anesthesia onlyPatients will receive spinal anesthesia only |
| spinal anesthesia and ultrasound-guided Genicular nerves block | Experimental | Biological: Spinal anesthesia and ultrasound-guided Genicular nerves blockPatients will receive spinal anesthesia and ultrasound-guided Genicular nerves block |
| Spinal anesthesia and US guided Adductor canal nerve block plus infiltration of the interspace | Experimental | Biological: Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK)Patients will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block plus infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (PACK) block. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 21-60 years
- Both genders
- American Society of Anaesthesiologists physical status classification I - III
- Patients scheduled for elective unilateral knee arthroscopy under spinal anesthesia
Key exclusion criteria (9 listed)
- Patient refusal
- Preoperative neurological deficits
- Opioid-dependent (opioid intake more than 3 months)
- Chronic pain conditions
- Significant cardiac and respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesia onlyPatients will receive spinal anesthesia with 2-3 ml 0.5% (10-15 mg) hyperbaric bupivacaine plus 25 ug fentanyl at the L3/4 interspaces. | Procedure or surgery | spinal anesthesia only |
| Spinal anesthesia and ultrasound-guided Genicular nerves blockPatients will receive16 ml bupivacaine 0025% will be administered, and4 ml of this solution will be placed at each of the 4 target nerves. | Biological | spinal anesthesia and ultrasound-guided Genicular nerves block |
| Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK)Adductor Canal block (ACB) technique will be performed using 16 ml bupivacaine 0025% As regarding the Popliteal artery and the capsule of posterior knee block ('PACK), it will be performed Using 16 ml bupivacaine 0.25% | Biological | Spinal anesthesia and US guided Adductor canal nerve block plus infiltration of the interspace |
Primary outcome
Postoperative 24-hour rescue analgesic consumption
Time frame: 24 hours postoperative
Total postoperative 24-hour rescue analgesic consumption will be recorded
2 secondary outcomes
Post-operative pain
Time frame: 24 hours Postoperative
Time taken till 1st rescue analgesic request
Time frame: 24 hours Postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: Yes. The data will be available under a reasonable request from the corresponding author
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia only, Spinal anesthesia and ultrasound-guided Genicular nerves block and Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK) in people with Arthroscopy and Genicular Nerves Block, run by Tanta 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 4 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 24 Mar 2022. 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.
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?
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?
Postoperative 24-hour rescue analgesic consumption (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?
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 24 Mar 2022.