Comparing spinal anesthesia and general anesthesia in patients with ankle fracture

Spinal anesthesia and general anesthesia in ankle fracture patients - a prospective, randomized controlled trial - Spinankle-trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003903-32-FI

Enrollment

110

Registered

2020-08-14

Start date

2020-08-26

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle fracture needing surgical fixation

Interventions

Trade Name: Bicain pond spinal Pharmaceutical Form: Concentrate for solution for injection Trade Name: Fentanyl Pharmaceutical Form: Suspension for injection Trade Name: Profast Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ankle fracture needing surgical repair age 18 years or more cognition suitable to understand the study protocol and give informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: Contraindications to spinal anesthesia other injuries operated at the same time marked cognitive or psychiatric condition marked substance misuse marked neuropathic condition in the operated leg chronic opioid medication pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare postoperative opioid consumption between spinal and general anesthesia in patients with surgically treated ankle fracture.;Secondary Objective: We also compare postoperative nausea and vomiting (PONV), time in the operating room, time in the recovery room and time of hospital stay.;Primary end point(s): postoperative opioid consumption in milligrams up to 24 hours postoperatively (converted into an intravenous equianalgesic dose of oxycodone in milligrams);Timepoint(s) of evaluation of this end point: 24 hours postoperatively	—

Measure

Time frame

Main Objective: To compare postoperative opioid consumption between spinal and general anesthesia in patients with surgically treated ankle fracture.;Secondary Objective: We also compare postoperative nausea and vomiting (PONV), time in the operating room, time in the recovery room and time of hospital stay.;Primary end point(s): postoperative opioid consumption in milligrams up to 24 hours postoperatively (converted into an intravenous equianalgesic dose of oxycodone in milligrams);Timepoint(s) of evaluation of this end point: 24 hours postoperatively

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Secondary

Measure	Time frame
Secondary end point(s): use of induction space to initiate anesthesia use of non-opioids (dexamethasone, NSAIDs, acetaminophen) different time phases on the operation (total time in OR, time to induce anesthesia, duration of the surgical phase) use of special anesthetic techniques (rescue regional blocks, patient controlled analgesia) use of tourniquet and time of tourniquet use opioid use during different phases (intraoperative use, postanesthesia care unit, ward up to 48 hours) PONV at the ward maximal pain in the PACU (NRS, VRS) length of stay in the hospital maximal pain > 5 VAS (% of patients) postoperative delirium;Timepoint(s) of evaluation of this end point: at the pacu, up to 24 hours, up to 48 hours	—

Measure

Time frame

Secondary end point(s): use of induction space to initiate anesthesia use of non-opioids (dexamethasone, NSAIDs, acetaminophen) different time phases on the operation (total time in OR, time to induce anesthesia, duration of the surgical phase) use of special anesthetic techniques (rescue regional blocks, patient controlled analgesia) use of tourniquet and time of tourniquet use opioid use during different phases (intraoperative use, postanesthesia care unit, ward up to 48 hours) PONV at the ward maximal pain in the PACU (NRS, VRS) length of stay in the hospital maximal pain > 5 VAS (% of patients) postoperative delirium;Timepoint(s) of evaluation of this end point: at the pacu, up to 24 hours, up to 48 hours

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Countries

Finland

Contacts

Public ContactTimo Kaakinen

University of Oulu

timo.kaakinen@oulu.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026