Anterior Cruciate Ligament RuptureNCT05068063
Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia
A study testing Bupivacaine Injection and normal Saline in people with Anterior Cruciate Ligament Rupture and Acute Pain, run by University of Chile at 2 sites in Chile.
Trial summary
An adequate balance between analgesia and motor function is an essential requirement to facilitate functional recovery and early discharge after anterior cruciate ligament (ACL) reconstruction surgery. Proximal nerve blocks (i.e. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Acute Pain, Pain, Postoperative
- What is being tested?
- Bupivacaine Injection and normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesChile
- Study dates
- 1 Jun 2022to 15 Oct 2022
- 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
- Patient scheduled to undergo anterior cruciate ligament reconstruction under general anesthesia with ipsilateral autologous graft.
- Age between 18 and 65 years
- American Society of Anesthesiologists classification 1-3
- Body mass index between 19 and 35 (kg/m2)
Who cannot join
- Adults who are unable to give their own consent
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- Allergy to local anesthetics (LAs), morphine or tramadol
Show all 10Show fewer
- Pregnancy
- ACL revision surgery
- Contralateral graft or any type of allograft
- Chronic pain syndromes requiring opioid intake at home
Trial locations and contacts
2 sites in 1 country.
Chile2 sites, 1 recruiting
- Active, not recruiting
Clinica Alemana de Santiago
Santiago, RM
- Recruiting
Hospital Clinico Universidad de Chile
Santiago, RM
Sebastian L Layera, MD, +562 29788221, sebastianlayera@gmail.com
About this study
Official title: A Randomised Comparison Between Combined Femoral Triangle Block+IPACK Block and Femoral Triangle Block for Anterior Cruciate Ligament Reconstruction Analgesia
An adequate balance between analgesia and motor function is an essential requirement to facilitate functional recovery and early discharge after anterior cruciate ligament (ACL) reconstruction surgery.
Proximal nerve blocks (i.e. femoral and sciatic nerve blocks) are associated with optimal analgesia, but they can cause muscle weakness, interfering with rehabilitation and increasing the risk of falls .
Read more
A recent randomized controlled trial concluded that, compared to mid-and distal ACB, a distal femoral triangle block (FTB) is associated with lower opioid consumption and improved postoperative analgesia for ambulatory ACL reconstruction.
In ACL reconstruction surgery there are other potential sources of pain not covered by a FTB, such as intra-articular structures (menisci, cruciate ligaments), posterior knee capsule and the graft donor site.
Evidence supporting the addition of an IPACK block to a FTB has been studied for patients undergoing total knee replacement, nonetheless, there is no trial analyzing the analgesic contribution of IPACK to a FTB in the context of ACL reconstruction surgery.
In this multicentric trial, the investigators set out to analyze the analgesic benefit of adding an IPACK block to a FTB.
- Being tested
- Bupivacaine Injection, normal Saline
- Keywords
- nerve block, IPACK, femoral triangle
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Acute Pain, Pain, Postoperative, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine InjectionDrug
Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of Bupivacaine 0.25%
normal SalineDrug
Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of normal saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Femoral Triangle + IPACK block | Experimental | Patients randomized to receive a combination of femoral triangle block and active IPACK block Receives: Drug: Bupivacaine Injection |
| Femoral Triangle block | Active comparator | Patients randomized to receive a combination of femoral triangle block and sham IPACK block Receives: Drug: normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain scores at 2 hours of arrival to Post Anesthesia Care Unit (PACU)
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Measured: 2 hours after arrival to PACU
Secondary outcomes (17)
Post-operative static pain scores at 0 hours of arrival to PACU
Pain evaluated at rest in Numeric Rating Score from 0 to 10 points
Measured: 0 hours after arrival to PACU
Post-operative static pain scores at PACU discharge
Pain evaluated at rest in Numeric Rating Score from 0 to 10 points
Measured: at discharge of PACU up to 2 hours postoperatively
Post-operative static pain scores at 6 hours of arrival to PACU
Pain evaluated at rest in Numeric Rating Score from 0 to 10 points
Measured: 6 hours after arrival to PACU
Post-operative static pain scores at 12 hours of arrival to PACU
Pain evaluated at rest in Numeric Rating Score from 0 to 10 points
Measured: 12 hours after arrival to PACU
Post-operative static pain scores at 24 hours of arrival to PACU
Pain evaluated at rest in Numeric Rating Score from 0 to 10 points
Measured: 24 hours after arrival to PACU
Post-operative dynamic pain scores at 0 hours of arrival to PACU
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Measured: 0 hours after arrival to PACU
Post-operative dynamic pain scores at PACU discharge
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Measured: at discharge of PACU up to 2 hours postoperatively
Post-operative dynamic pain scores at 6 hours of arrival to PACU
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Measured: 6 hours after arrival to PACU
Post-operative dynamic pain scores at 12 hours of arrival to PACU
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Measured: 12 hours after arrival to PACU
Post-operative dynamic pain scores at 24 hours of arrival to PACU
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Measured: 24 hours after arrival to PACU
Femoral Triangle Block success assessment at 2 hours
Sensory block will be assessed with ice on the medial leg
Measured: 2 hours after arrival to PACU
Incidence of opioid related adverse events
Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression, urinary retention)
Measured: 24 hours after arrival to PACU
Intraoperative opioid consumption
Total opioid use during intraoperative period
Measured: From anesthesia induction to extubation
PACU opioid consumption
total opioid consumption during PACU stay
Measured: from PACU arrival to discharge up to 2 hours postoperatively
Total opioid consumption
Total opioid consumption
Measured: 6 hours, 12 hours and 24 hours after PACU arrival
Nerve block complications
Incidence of nerve block complications (vascular puncture, puncture site erythema, hematoma, foot drop, LAST)
Measured: From nerve block performance up to 24 hours after PACU arrival
Lower limb tourniquet
lower limb tourniquet duration
Measured: from inflation of pneumatic device to tourniquet release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Jun 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Alemana de Santiago
- Responsible party
- Principal investigator, Sebastian Layera, University of Chile
- Investigators
- Andrea Gonzalez, MD, Principal investigator, Clinica Alemana de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068063
- Sponsor's protocol ID
- IPACK1
- Status last verified
- Jun 2022
- First submitted
- 15 Sep 2021
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilde J, Bedi A, Altchek DW. Revision anterior cruciate ligament reconstruction. Sports Health. 2014 Nov;6(6):504-18. doi: 10.1177/1941738113500910.
PubMed 25364483Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.
PubMed 19680735Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045.
PubMed 26938989Abdallah FW, Mejia J, Prasad GA, Moga R, Chahal J, Theodoropulos J, Dwyer T, Brull R. Opioid- and Motor-sparing with Proximal, Mid-, and Distal Locations for Adductor Canal Block in Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial. Anesthesiology. 2019 Sep;131(3):619-629. doi: 10.1097/ALN.0000000000002817.
PubMed 31246607Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.
PubMed 25140514Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21.
PubMed 31980156Johnston DF, Black ND, Cowden R, Turbitt L, Taylor S. Spread of dye injectate in the distal femoral triangle versus the distal adductor canal: a cadaveric study. Reg Anesth Pain Med. 2019 Jan;44(1):39-45. doi: 10.1136/rapm-2018-000002.
PubMed 30640651Chan E, Howle R, Onwochei D, Desai N. Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. Reg Anesth Pain Med. 2021 Sep;46(9):784-805. doi: 10.1136/rapm-2021-102681. Epub 2021 May 14.
PubMed 33990439Bushnell BD, Sakryd G, Noonan TJ. Hamstring donor-site block: evaluation of pain control after anterior cruciate ligament reconstruction. Arthroscopy. 2010 Jul;26(7):894-900. doi: 10.1016/j.arthro.2009.11.022. Epub 2010 May 13.
PubMed 20620788
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Comparison Between Combined Femoral Triangle Block+IPACK Block and Femoral Triangle Block for Anterior Cruciate Ligament Reconstruction Analgesia
- ClinicalTrials.gov ID
- NCT05068063
- Acronym / sponsor ID
- IPACK1
- Keywords
- nerve block, IPACK, femoral triangle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Clinica Alemana de Santiago
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 5 Oct 2021 (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.
An adequate balance between analgesia and motor function is an essential requirement to facilitate functional recovery and early discharge after anterior cruciate ligament (ACL) reconstruction surgery.
Proximal nerve blocks (i.e. femoral and sciatic nerve blocks) are associated with optimal analgesia, but they can cause muscle weakness, interfering with rehabilitation and increasing the risk of falls .
A recent randomized controlled trial concluded that, compared to mid-and distal ACB, a distal femoral triangle block (FTB) is associated with lower opioid consumption and improved postoperative analgesia for ambulatory ACL reconstruction.
In ACL reconstruction surgery there are other potential sources of pain not covered by a FTB, such as intra-articular structures (menisci, cruciate ligaments), posterior knee capsule and the graft donor site.
Evidence supporting the addition of an IPACK block to a FTB has been studied for patients undergoing total knee replacement, nonetheless, there is no trial analyzing the analgesic contribution of IPACK to a FTB in the context of ACL reconstruction surgery.
In this multicentric trial, the investigators set out to analyze the analgesic benefit of adding an IPACK block to a FTB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Triangle + IPACK block | Experimental | Drug: Bupivacaine InjectionPatients randomized to receive a combination of femoral triangle block and active IPACK block |
| Femoral Triangle block | Active comparator | Drug: normal SalinePatients randomized to receive a combination of femoral triangle block and sham IPACK block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient scheduled to undergo anterior cruciate ligament reconstruction under general anesthesia with ipsilateral autologous graft.
- Age between 18 and 65 years
- American Society of Anesthesiologists classification 1-3
- Body mass index between 19 and 35 (kg/m2)
Key exclusion criteria (10 listed)
- Adults who are unable to give their own consent
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
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 InjectionUltrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of Bupivacaine 0.25% | Drug | Femoral Triangle + IPACK block |
| normal SalineUltrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of normal saline 0.9% | Drug | Femoral Triangle block |
Primary outcome
Post-operative pain scores at 2 hours of arrival to Post Anesthesia Care Unit (PACU)
Time frame: 2 hours after arrival to PACU
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
17 secondary outcomes
Post-operative static pain scores at 0 hours of arrival to PACU
Time frame: 0 hours after arrival to PACU
Post-operative static pain scores at PACU discharge
Time frame: at discharge of PACU up to 2 hours postoperatively
Post-operative static pain scores at 6 hours of arrival to PACU
Time frame: 6 hours after arrival to PACU
Post-operative static pain scores at 12 hours of arrival to PACU
Time frame: 12 hours after arrival to PACU
Post-operative static pain scores at 24 hours of arrival to PACU
Time frame: 24 hours after arrival to PACU
Post-operative dynamic pain scores at 0 hours of arrival to PACU
Time frame: 0 hours after arrival to PACU
Post-operative dynamic pain scores at PACU discharge
Time frame: at discharge of PACU up to 2 hours postoperatively
Post-operative dynamic pain scores at 6 hours of arrival to PACU
Time frame: 6 hours after arrival to PACU
Post-operative dynamic pain scores at 12 hours of arrival to PACU
Time frame: 12 hours after arrival to PACU
Post-operative dynamic pain scores at 24 hours of arrival to PACU
Time frame: 24 hours after arrival to PACU
Femoral Triangle Block success assessment at 2 hours
Time frame: 2 hours after arrival to PACU
Incidence of opioid related adverse events
Time frame: 24 hours after arrival to PACU
Intraoperative opioid consumption
Time frame: From anesthesia induction to extubation
PACU opioid consumption
Time frame: from PACU arrival to discharge up to 2 hours postoperatively
Total opioid consumption
Time frame: 6 hours, 12 hours and 24 hours after PACU arrival
Nerve block complications
Time frame: From nerve block performance up to 24 hours after PACU arrival
Lower limb tourniquet
Time frame: from inflation of pneumatic device to tourniquet release
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Background: PubMed 25364483Wilde J, Bedi A, Altchek DW. Revision anterior cruciate ligament reconstruction. Sports Health. 2014 Nov;6(6):504-18. doi: 10.1177/1941738113500910.
- Background: PubMed 19680735Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.
- Background: PubMed 26938989Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045.
- Background: PubMed 31246607Abdallah FW, Mejia J, Prasad GA, Moga R, Chahal J, Theodoropulos J, Dwyer T, Brull R. Opioid- and Motor-sparing with Proximal, Mid-, and Distal Locations for Adductor Canal Block in Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial. Anesthesiology. 2019 Sep;131(3):619-629. doi: 10.1097/ALN.0000000000002817.
- Background: PubMed 25140514Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.
- Background: PubMed 31980156Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21.
- Background: PubMed 30640651Johnston DF, Black ND, Cowden R, Turbitt L, Taylor S. Spread of dye injectate in the distal femoral triangle versus the distal adductor canal: a cadaveric study. Reg Anesth Pain Med. 2019 Jan;44(1):39-45. doi: 10.1136/rapm-2018-000002.
- Background: PubMed 33990439Chan E, Howle R, Onwochei D, Desai N. Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. Reg Anesth Pain Med. 2021 Sep;46(9):784-805. doi: 10.1136/rapm-2021-102681. Epub 2021 May 14.
- Background: PubMed 20620788Bushnell BD, Sakryd G, Noonan TJ. Hamstring donor-site block: evaluation of pain control after anterior cruciate ligament reconstruction. Arthroscopy. 2010 Jul;26(7):894-900. doi: 10.1016/j.arthro.2009.11.022. Epub 2010 May 13.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Rupture
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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.
Andrea Gonzalez, MD principal investigator
Clinica Alemana de Santiago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine Injection and normal Saline in people with Anterior Cruciate Ligament Rupture and Acute Pain, run by University of Chile at 2 sites in Chile.
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 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 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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 Sebastian L Layera, MD (+562 29788221, sebastianlayera@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain scores at 2 hours of arrival to Post Anesthesia Care Unit (PACU) (time frame: 2 hours after arrival to PACU). 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 NCT05068063, which also lists 9 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 Jun 2022.