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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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

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 groups in NCT05269095
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.

21 Mar 202221 Mar 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
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Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
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Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
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All Arthroscopy trials

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.

Detailed description

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

Related trials for Arthroscopy

RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
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Recruiting
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
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Not yet recruiting
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
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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?

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?

On the ClinicalTrials.gov record for NCT05269095.

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.