AnalgesiaPIPACKNCT06179641
Comparison of Two Different Regional Analgesia Techniques for Patients Undergoing Total Knee Arthroplasty
A study testing Selective tibial nerve block and IPACK block in people with Analgesia and Arthropathy of Knee, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The objective of this clinical trial is to compare two regional analgesia techniques in patients undergoing total knee arthroplasty: IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) vs selective tibial nerve block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Arthropathy of Knee, Postoperative Pain
- What is being tested?
- Selective tibial nerve block and IPACK block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Feb 2024to 18 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists classification I-III
- 18 yo or older
- patients scheduled for total knee arthroplasty under central spinal anesthesia
- informed consent signed
Who cannot join
- Refusal or inability for informed consent
- Known allergies to ropivacaine, acetaminophen, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone
- Secondary surgical revision
- Opioid treatment such as morphine, hydrocodone, hydromorphone, tramadol, methadone, fentanyl, buprenorphine or codeine
- Bleeding diathesis
- Neurological deficit
Show all 9Show fewer
- Known renal insufficiency (eGFR <45 ml/min)
- Known hepatic insufficiency (Child score B or C)
- Alcohol abuse
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Lausanne
Lausanne, Canton of Vaud, 1011
Marta Szyszko du Bois d'Aische, +41795564002, marta.szyszko@chuv.ch
About this study
Official title: Analgesic Efficacy of IPACK Versus Selective Tibial Nerve Block in Patients Undergoing Total Knee Arthroplasty Under Spinal Anesthesia With an Adductor Canal Block: a Randomized Controlled Double-blinded Trial
The objective of this clinical trial is to compare two regional analgesia techniques in patients undergoing total knee arthroplasty: IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) vs selective tibial nerve block. The main question is whether one of these peripheral blocks is more effective in reducing postoperative pain than the other. All patients will have a spinal block with an adductor canal block. One group will receive an IPACK block and the other group, a selective tibial nerve block. Postoperative pain scores and morphine consumption, among others, will be compared between groups.
Read the detailed description
The aim of this randomized controlled double blinded trail is to compare an analgesic effect of an IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block vs selective tibial nerve block in patients scheduled for total knee arthroplasty under spinal anesthesia with an adductor canal block.
The investigators presume that association of a selective tibial nerve block with an adductor canal block provides better postoperative analgesia than a combination of an IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block with an adductor canal block. The research team plan on including 100 patients and randomly assign them to two groups of 50 patients each. After written informed consent, patients will be allocated to one of the groups, following a computer-generated list of randomization. All patients will receive central spinal anesthesia with 12.5 mg of hyperbaric bupivacaine with 100 mcg of morphine and an adductor canal block with 150 mg of ropivacaine. IPACK block group will then receive an IPACK block with 38 mg of ropivacaine and a tibial nerve group will receive a selective tibial nerve block with 37.5 mg of ropivacaine.
During the surgery, iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg. will be administered to all patients.
After surgery, all patients will be prescribed an iv patient-controlled analgesia (PCA) of morphine (boluses of 2 mg available every 10 min, maximum of 40 mg every 4 hours) along with oral acetaminophen (1000 mg every 6 h) and oral ibuprofen (400 mg every 8 hours). Oral ondansetron 4 mg every 8 hours will be available on request in case of nausea or vomiting.
The primary outcome will be the cumulative iv morphine consumption at 24 h postoperatively. Secondary outcomes will include pain- and functional-related outcomes. Pain related outcomes are cumulative morphine consumption in the recovery room, at day 1, day 2 and day 3 postoperatively, rest and dynamic pain scores, duration of peripheral nerve block defined as the time between the execution of the block and the first dose of iv morphine, incidence of postoperative nausea and vomiting and pruritus during 3 days following surgical intervention, incidence of peroneal nerve block and complications of peripheral nerve blocks.
- Conditions
- Analgesia, Arthropathy of Knee, Postoperative Pain
- Being tested
- Selective tibial nerve block, IPACK block
- Keywords
- nerve block, pain management, postoperative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective tibial nerve blockProcedure or surgery
The selective tibial nerve block will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position at the popliteal crease to visualize the popliteal artery and the tibial nerve in short axis. A 21-gauge 50mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound bean from a medial to lateral direction. Once the needle tip is adjacent to the tibial nerve, 5 ml of ropivacaine 0.75% will be injected to achieve an adequate spread of local anesthetics around the nerve.
IPACK blockProcedure or surgery
The IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position proximal to the popliteal crease to visualize the popliteal artery in short axis. A 21-gauge 100 mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound beam, in a lateral to medial direction, between the popliteal artery and the posterior capsule, where nineteen mL of ropivacaine 0.2% will be injected under ultrasound guidance. The distribution of local anesthetics will be observed above the posterior capsule.
| Study group | Role | What they receive |
|---|---|---|
| IPACK group | Active comparator | IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block Receives: Procedure: IPACK block |
| Tibial nerve group | Experimental | selective tibial nerve block Receives: Procedure: Selective tibial nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total iv morphine consumption
consumption in mg
Measured: 24 hours postoperatively
Secondary outcomes (12)
Morphine consumption in the recovery room
consumption in mg
Measured: From admission till discharge from the recovery room, up to 2 hours
PCA administered morphine consumption
consumption in mg administered by PCA
Measured: at day 1, day 2 and day 3 postoperatively
rest and dynamic pain scores
Visual Analogue scale(VAS), 0-10 where 0 is no pain and 10 is the worst pain imaginable
Measured: at day 1, day 2 and day 3 postoperatively
Duration of peripheral nerve block
Time between execution of a peripheral nerve block and the first dose of iv morphine
Measured: From execution of a peripheral nerve block till administration of a first dose of iv morphine, up to 48 hours
Incidence of postoperative nausea and vomiting
Presence of nausea and vomiting in the postoperative period
Measured: at day 1, day 2 and day 3 postoperatively
Incidence of pruritus
Presence of pruritus
Measured: at day 1, day 2 and day 3 postoperatively
peroneal nerve block
presence of peroneal nerve block
Measured: at day 1, day 2 and day 3 postoperatively
complications of peripheral nerve blocks
iv injection, hematoma, infection
Measured: at the moment of execution of the block (day 0) and at day 3 postoperatively
passive and active motion range
joint motion in degrees
Measured: at day 3 postoperatively
quadriceps strength
Percentage of strength as compared with the opposite leg
Measured: at day 3 postoperatively
walking distance
walking distance without pain
Measured: at 72h postoperatively
hospital stay
length of hospital stay in days
Measured: from admission to the hospital till discharge, up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start8 Feb 2024
- Primary completion12 Jul 2025 (estimated)
- Study completion18 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Model description
- single centered, prospective, randomized double blinded controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179641
- Sponsor's protocol ID
- CER-VD 2023-02041
- Acronym
- PIPACK
- Status last verified
- Feb 2024
- First submitted
- 30 Nov 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
PubMed 9661552Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394.
PubMed 20798443Williams DP, O'Brien S, Doran E, Price AJ, Beard DJ, Murray DW, Beverland DE. Early postoperative predictors of satisfaction following total knee arthroplasty. Knee. 2013 Dec;20(6):442-6. doi: 10.1016/j.knee.2013.05.011. Epub 2013 Jun 16.
PubMed 23777807Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
PubMed 19844772van der Wal M, Lang SA, Yip RW. Transsartorial approach for saphenous nerve block. Can J Anaesth. 1993 Jun;40(6):542-6. doi: 10.1007/BF03009739.
PubMed 8403121Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.
PubMed 18627367Silverman ER, Vydyanathan A, Gritsenko K, Shaparin N, Singh N, Downie SA, Kosharskyy B. The Anatomic Relationship of the Tibial Nerve to the Common Peroneal Nerve in the Popliteal Fossa: Implications for Selective Tibial Nerve Block in Total Knee Arthroplasty. Pain Res Manag. 2017;2017:7250181. doi: 10.1155/2017/7250181. Epub 2017 Feb 2.
PubMed 28260964Paulou F, Wegrzyn J, Rossel JB, Gonvers E, Antoniadis A, Kagi M, Wolmarans MR, Lambert J, Albrecht E. Analgesic efficacy of selective tibial nerve block versus partial local infiltration analgesia for posterior pain after total knee arthroplasty: a randomized, controlled, triple-blinded trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101223. doi: 10.1016/j.accpm.2023.101223. Epub 2023 Apr 6.
PubMed 37030393
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of IPACK Versus Selective Tibial Nerve Block in Patients Undergoing Total Knee Arthroplasty Under Spinal Anesthesia With an Adductor Canal Block: a Randomized Controlled Double-blinded Trial
- ClinicalTrials.gov ID
- NCT06179641
- Acronym / sponsor ID
- PIPACK / CER-VD 2023-02041
- Conditions
- Analgesia, Arthropathy of Knee, Postoperative Pain
- Keywords
- nerve block, pain management, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 12 Jul 2025 (estimated)
- Study completion
- 18 Jul 2025 (estimated)
- First posted
- 22 Dec 2023 (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.
The objective of this clinical trial is to compare two regional analgesia techniques in patients undergoing total knee arthroplasty: IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) vs selective tibial nerve block. The main question is whether one of these peripheral blocks is more effective in reducing postoperative pain than the other. All patients will have a spinal block with an adductor canal block. One group will receive an IPACK block and the other group, a selective tibial nerve block. Postoperative pain scores and morphine consumption, among others, will be compared between groups.
Detailed description
The aim of this randomized controlled double blinded trail is to compare an analgesic effect of an IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block vs selective tibial nerve block in patients scheduled for total knee arthroplasty under spinal anesthesia with an adductor canal block.
The investigators presume that association of a selective tibial nerve block with an adductor canal block provides better postoperative analgesia than a combination of an IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block with an adductor canal block. The research team plan on including 100 patients and randomly assign them to two groups of 50 patients each. After written informed consent, patients will be allocated to one of the groups, following a computer-generated list of randomization. All patients will receive central spinal anesthesia with 12.5 mg of hyperbaric bupivacaine with 100 mcg of morphine and an adductor canal block with 150 mg of ropivacaine. IPACK block group will then receive an IPACK block with 38 mg of ropivacaine and a tibial nerve group will receive a selective tibial nerve block with 37.5 mg of ropivacaine.
During the surgery, iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg. will be administered to all patients.
After surgery, all patients will be prescribed an iv patient-controlled analgesia (PCA) of morphine (boluses of 2 mg available every 10 min, maximum of 40 mg every 4 hours) along with oral acetaminophen (1000 mg every 6 h) and oral ibuprofen (400 mg every 8 hours). Oral ondansetron 4 mg every 8 hours will be available on request in case of nausea or vomiting.
The primary outcome will be the cumulative iv morphine consumption at 24 h postoperatively. Secondary outcomes will include pain- and functional-related outcomes. Pain related outcomes are cumulative morphine consumption in the recovery room, at day 1, day 2 and day 3 postoperatively, rest and dynamic pain scores, duration of peripheral nerve block defined as the time between the execution of the block and the first dose of iv morphine, incidence of postoperative nausea and vomiting and pruritus during 3 days following surgical intervention, incidence of peroneal nerve block and complications of peripheral nerve blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- single centered, prospective, randomized double blinded controlled trial
| Arm | Type | Receives |
|---|---|---|
| IPACK group | Active comparator | Procedure: IPACK blockIPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block |
| Tibial nerve group | Experimental | Procedure: Selective tibial nerve blockselective tibial nerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists classification I-III
- 18 yo or older
- patients scheduled for total knee arthroplasty under central spinal anesthesia
- informed consent signed
Key exclusion criteria (9 listed)
- Refusal or inability for informed consent
- Known allergies to ropivacaine, acetaminophen, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone
- Secondary surgical revision
- Opioid treatment such as morphine, hydrocodone, hydromorphone, tramadol, methadone, fentanyl, buprenorphine or codeine
- Bleeding diathesis
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 |
|---|---|---|
| Selective tibial nerve blockThe selective tibial nerve block will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position at the popliteal crease to visualize the popliteal artery and the tibial nerve in short axis. A 21-gauge 50mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound bean from a medial to lateral direction. Once the needle tip is adjacent to the tibial nerve, 5 ml of ropivacaine 0.75% will be injected to achieve an adequate spread of local anesthetics around the nerve. | Procedure or surgery | Tibial nerve group |
| IPACK blockThe IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position proximal to the popliteal crease to visualize the popliteal artery in short axis. A 21-gauge 100 mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound beam, in a lateral to medial direction, between the popliteal artery and the posterior capsule, where nineteen mL of ropivacaine 0.2% will be injected under ultrasound guidance. The distribution of local anesthetics will be observed above the posterior capsule. | Procedure or surgery | IPACK group |
Primary outcome
Total iv morphine consumption
Time frame: 24 hours postoperatively
consumption in mg
12 secondary outcomes
Morphine consumption in the recovery room
Time frame: From admission till discharge from the recovery room, up to 2 hours
PCA administered morphine consumption
Time frame: at day 1, day 2 and day 3 postoperatively
rest and dynamic pain scores
Time frame: at day 1, day 2 and day 3 postoperatively
Duration of peripheral nerve block
Time frame: From execution of a peripheral nerve block till administration of a first dose of iv morphine, up to 48 hours
Incidence of postoperative nausea and vomiting
Time frame: at day 1, day 2 and day 3 postoperatively
Incidence of pruritus
Time frame: at day 1, day 2 and day 3 postoperatively
peroneal nerve block
Time frame: at day 1, day 2 and day 3 postoperatively
complications of peripheral nerve blocks
Time frame: at the moment of execution of the block (day 0) and at day 3 postoperatively
passive and active motion range
Time frame: at day 3 postoperatively
quadriceps strength
Time frame: at day 3 postoperatively
walking distance
Time frame: at 72h postoperatively
hospital stay
Time frame: from admission to the hospital till discharge, up to 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 9661552Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
- Background: PubMed 20798443Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394.
- Background: PubMed 23777807Williams DP, O'Brien S, Doran E, Price AJ, Beard DJ, Murray DW, Beverland DE. Early postoperative predictors of satisfaction following total knee arthroplasty. Knee. 2013 Dec;20(6):442-6. doi: 10.1016/j.knee.2013.05.011. Epub 2013 Jun 16.
- Background: PubMed 19844772Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
- Background: PubMed 8403121van der Wal M, Lang SA, Yip RW. Transsartorial approach for saphenous nerve block. Can J Anaesth. 1993 Jun;40(6):542-6. doi: 10.1007/BF03009739.
- Background: PubMed 18627367Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.
- Background: PubMed 28260964Silverman ER, Vydyanathan A, Gritsenko K, Shaparin N, Singh N, Downie SA, Kosharskyy B. The Anatomic Relationship of the Tibial Nerve to the Common Peroneal Nerve in the Popliteal Fossa: Implications for Selective Tibial Nerve Block in Total Knee Arthroplasty. Pain Res Manag. 2017;2017:7250181. doi: 10.1155/2017/7250181. Epub 2017 Feb 2.
- Background: PubMed 37030393Paulou F, Wegrzyn J, Rossel JB, Gonvers E, Antoniadis A, Kagi M, Wolmarans MR, Lambert J, Albrecht E. Analgesic efficacy of selective tibial nerve block versus partial local infiltration analgesia for posterior pain after total knee arthroplasty: a randomized, controlled, triple-blinded trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101223. doi: 10.1016/j.accpm.2023.101223. Epub 2023 Apr 6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective tibial nerve block and IPACK block in people with Analgesia and Arthropathy of Knee, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 9 Feb 2024. 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 Switzerland. 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 Marta Szyszko du Bois d'Aische (+41795564002, marta.szyszko@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total iv morphine consumption (time frame: 24 hours postoperatively). 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 NCT06179641, which also lists 8 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 9 Feb 2024.