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Prospective cohort assessing the effects of ankle block (local infiltration analgesia) on duration of analgesia, pain, opioid consumption, and patient satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ankle block | Any participant receiving an ankle block (local infiltration analgesia). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankle block | Procedure | Injection of local anaesthetics at the level of the ankle blindly (local infiltration analgesia). The dose, volume, and type of local anaesthetic will be registered. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of analgesia, measured as time to first pain | Duration of analgesia measured as time to first pain as reported by the patient. The duration of analgesia is expected to be less than 24 hours. If the duration of analgesia exceeds 24 hours, follow-up will be performed until return of normal sensation is ensured. Duration of analgesia will be set to 24 hours for participants having a duration of analgesia exceeding 24 hours. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain in the post-anaesthesia care unit, measured on the Numerical Rating Scale (NRS) | Pain in the post-anaesthesia care unit as reported by the patient on the NRS (0 to 10 points, 0 no pain, 10 worst perceiveable pain). The assessment will be performed just prior to discharge from the post-anaesthesia care unit. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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All patients undergoing surgery of the foot or ankle will be assessed for eligibility. We will attempt to include all adult patients receiving local infiltration analgesia of the ankle for pain management following foot or ankle surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolaj Kaack Schou, Med.student. | Contact | +45 56 63 15 00 | niksc@regionsjaelland.dk | |
| Mathias Maagaard, MD | Contact | +45 56 63 15 00 | mmaag@regionsjaelland.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Recruiting | Køge | Zealand Region of Denmark | 4600 | Denmark |
Individual participant data will be shared upon reasonable request to the coordinating investigator.
Data will be made available after primary publication with no time limit.
Reasonable request to the coordinating investigator.
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| Participants with failed block |
Failed block will be defined as participants experiencing pain (NRS > 0) prior to discharge from the post-anaesthesia care unit. |
| 24 hours |
| Pain at 6 hours postoperatively, measured on the NRS | Pain at 6 hours postoperatively measured on the NRS as reported by the participant. | 6 hours |
| Pain at 24 hours postoperatively, measured on the NRS | Pain at 24 hours postoperatively measured on the NRS as reported by the participant. | 24 hours |
| Cumulative opioid consumption at 24 hours postoperatively | Cumulative opioid consumption at 24 hours postoperatively. Opioid consumption will be converted to intravenous morphine equivalents. Intraoperative opioid use will not be included. | 24 hours |
| Participant satisfaction related to ankle block | Participants will be asked if they wanted a longer block duration, if they wanted a shorter block duration, and if block duration was adequate (binary outcomes, yes/no). | 24 hours |
| Unplanned admission | Most participants will be discharged directly from the post-anaesthesia care unit and some will have planned hospital admission following surgery. Unplanned admission will be defined as an admission that was not planned in advance. The reason for admission will be recorded. | 24 hours |
| Postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting. | 24 hours |