An interventional study of SAX catheter insertion and LAX catheter insertion in Anesthesia, Pain, Postoperative and Pain, sponsored by Nordsjaellands Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by Nordsjaellands Hospital · Not applicable, Interventional, and Device feasibility
Among 180 studies in Pain, Postoperative with a site in Denmark — 8 open to participants now, 9 under way, 2 of them phase 3. Pain, Postoperative · Denmark.
Among the 180 studies in Pain, Postoperative with a site in Denmark, this one is the 121st largest by enrollment of the 129 interventional ones that give a count, is one of 12 that started in 2017, is one of 36 with no phase, and was the 109th registered.
5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.
Browse Pain, Postoperative studies →8 of the 180 studies in Pain, Postoperative with a site in Denmark are open now. Recruiting first, the newest first:
Anne Juul Wikkelsø · Sites in Denmark
Ages 18+ · Women only
Arash Afshari · Sites in Denmark
Ages 1–6
Aarhus University Hospital · Sites in Denmark
Ages 18+
Esbjerg Hospital - University Hospital of Southern Denmark · Sites in Denmark
Ages 18–70
Copenhagen University Hospital, Hvidovre · Sites in Denmark
Ages 18+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
180 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 7 · Phase 3 8 · Phase 4 78
First in 1999; this study’s year is marked. 12 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 75 across 4,825 interventional studies indexed under Pain, Postoperative.
Median enrollment 72 across the 129 interventional studies, 102 across the 51 observational. Of the 152 that completed or were terminated, 4 (3%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 180 have an industry lead sponsor. The 10 most frequent:
Nordsjaellands Hospital is the lead sponsor of 89 studies on the registry; 20 are open to participants now.
Nordsjaellands Hospital has 8 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
3 of the studies in Pain, Postoperative with a site in Denmark that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05541276Phase 3Arash AfshariMELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children | 2027-03-01 |
| NCT06797973Anne Juul WikkelsøEfficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Planned Caesarean Section | 2027-05-31 |
| NCT06222151Esbjerg Hospital - University Hospital of Southern DenmarkRecovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization | 2027-06-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 180 studies in Pain, Postoperative with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a randomized clinical trial in healthy volunteers. 12 volunteers will have suture-method catheters placed in the adductor canal of each leg using the long-axis plane and short-axis plane technique. The investigators will inject LA in both catheters to confirm correct position. Following return of cold sensation the catheter is then displaced intentionally. The orifice is identified by injection of isotonic saline to ensure a proper displacement (spread outside of the adductor canal) and the distance from the delivery orifice of the catheter to the adductor canal is noted. A second investigator will assess distance from the LA delivery orifice of the catheter to the adductor canal using hydrodissection with isotonic saline to pinpoint the delivery orifice and subsequently reposition the catheter to obtain LA spread within the adductor canal. Successful repositioning is defined as a combination of LA spread within the adductor canal and loss of cold sensation on the medial part of the lower leg.
The study objective is to investigate whether it is possible to reposition a displaced suture-method catheter using ultrasound.
A peripheral nerve catheter will be inserted on each side under US guidance. An investigator will insert one catheter in the short-axis plane of the adductor canal using an in plane technique: The needle is inserted through the vastus medialis into the adductor canal and exits superficial to the femoral artery through the sartorius muscle.
The second catheter is inserted from proximal to distal direction in the long-axis plane using a combination of in-plane and out-of-plane techniques.
10mL of isotonic saline is used for hydro-dissection for both catheter insertions to facilitate placement. Both catheters are injected with 15 mL LA with an immediate assessment of the spread being within or outside the adductor canal.
Loss of cold sensation in the cutaneous saphenous nerve innervation area will be evaluated 15 minutes after injection by another investigator, who is blinded to allocation and randomization.
Following return of normal sensory function the catheter is then intentionally displaced at least 2 cm outside the adductor canal in the direction of the entry or exit site according to randomization. The distance from the LA delivery orifice of the catheter to the adductor canal is noted. Adequate displacement requires that injection of isotonic saline does not result in spread within the adductor canal.
A third investigator will assess distance from the LA delivery orifice of the catheter to the adductor canal and subsequently reposition the catheter using saline to pinpoint location of the delivery orifice. Once the catheter is repositioned LA is injected. The US scan during LA injection is performed with a fourth investigator present to evaluate for satisfactory spread within the adductor canal. The 2 investigators will not communicate regarding the assessment of spread within the adductor canal.
Evaluation of cold sensation on the medial part of the lower leg is performed 15 minutes after 15mL LA (lidocaine 10 mg/mL) injection by investigator 2. The catheters are then removed and the study is completed.
Distance from catheter delivery orifices to the adductor canal is defined as following:
Distance from the LA delivery orifice to the fascia surrounding the adductor canal is noted in the short axis group. The distance from the LA delivery orifice to the penetration of the aponeurosis lying just below the sartorius muscle is noted in the long axis group. Both represent anatomical reference points for the adductor canal.
Satisfactory spread within the adductor canal is defined as following:
The LA injection spreads deeper along the lateral side of the femoral artery, observed in the two-dimensional plane while producing minimal displacement of the roof and the overlying sartorius muscle.
The injection may spread occasionally superficially over the femoral artery within the canal and will then force the artery deeper. If the injection spreads more medially and superficially over the saphenous nerve and femoral artery in an anterolateral to posteromedial direction, initially resembling the injections within the adductor canal but separates the sartorius muscle from the femoral artery by lifting the sartorius muscle medially off the hyperechoic roof of the adductor canal it is considered not to spread within the adductor canal.13
Successful primary placement and subsequent repositioning is defined as the combination of satisfactory spread within the adductor canal (assessed using SAX visualization of the adductor canal for both catheters) and loss of cold sensation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ultrasound guided cather insertion in the short axis (SAX) of the adductor canal. Injection of lidocaine through the catheter
Procedure: SAX catheter insertion
Ultrasound guided cather insertion in the long axis (LAX) of the adductor canal. Injection of lidocaine through the catheter
Procedure: LAX catheter insertion
Suture-method catheter inserted in the short axis of the adductor canal
Suture-method catheter inserted in the long axis of the adductor canal
Successful repositioning
Defined as a combination of spread within the adductor canal and loss of cold sensation on the medial part of the lower leg after repositioning and second LA injection. - investigator 3 will evaluate spread and investigator 2 will evaluate cold sensation
Time frame: 15 min after second injection
Successful primary placement
Defined as a combination of spread within the adductor canal and loss of cold sensation after initial LA injection - investigator 1 will evaluate spread and investigator 2 will evaluate cold sensation
Time frame: 15 min after first injection
Estimation of Limits of Agreement
in evaluation of displacement distance of the catheter between investigator 1 and 3
Time frame: within 15 minutes, after displacement/repositioning.(recorded by after displacement and repeated just before attempted repositioning)
Interrater agreement for satisfactory spread within the adductor Canal, (Cohen's Kappa)
Investigator 3 and 4 will independently evaluate spread within the adductor canal.
Time frame: recorded immediately after second LA injection
Plan to share: No
Ran from Mar 2017 to primary completion in Apr 2017, 1 month.
Of 2,094 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 1 month is below that.
Counting every sponsor, half of 2,107 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Nordsjaellands Hospital