Post-operative pain treatment of patients after major ankle and foot surgery by comparing a nerve block with plain local anesthetic to a new protracted mixture of local anesthetics.

Comparison of the effect of saphenous block with plain bupivacaine vs. protracted bupivacaine mixture as a supplement to continuos sciatic catheter after major ankle and foot surgery: a randomized study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004207-78-DK

Enrollment

Unknown

Registered

2014-11-19

Start date

2015-01-07

Completion date

Unknown

Last updated

2016-04-11

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

Conditions

Post-operative pain after three types of major ankle and hind foot surgery: (1) total ankle arthroplasty, (2) ankle arthrodesis or (3) subtalar arthrodesis MedDRA version: 17.1 Level: LLT Classification code 10003396 Term: Arthroplasty NOS System Organ Class: 100000004865 MedDRA version: 17.1 Level: LLT Classification code 10016962 Term: Foot arthrodesis System Organ Class: 100000004865 MedDRA version: 17.1 Level: LLT Classification code 10002540 Term: Ankle arthrodesis System Organ Class: 10

Interventions

Trade Name: Dexagalen Product Name: Dexagalen Pharmaceutical Form: Solution for injection INN or Proposed INN: DEXAMETHASONE SODIUM PHOSPHATE Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Elective ankle or hind foot surgery either (1) total ankle arthroplasty, (2) ankle arthrodesis or (3) subtalar arthrodesis - Age = 18 - ASA I-III - Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Communication problems or dementia - Allergies to any medical product used in the study - Neuropathy of the sciatic or femoral nerve prior to the operation - Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease - BMI > 35 - Pregnancy - Daily use of opioids - Coagulation disorders - Infection at the site of injection or systemic infection

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to investigate whether addition of the adjuvant dexamethasone to bupivacaine-adrenaline can prolong the analgesic effect of the saphenous block compared to plain bupivacaine-adrenaline in patients after major ankle and hind foot surgery. ;Secondary Objective: - Compare the cumulated opioid consumption during the first 48 hours after surgery - Compare pain scores during the first 48 hours after surgery - Investigate the localization of the pain during the first 48 hours after surgery ;Primary end point(s): Duration of the saphenous nerve block with plain vs. protracted bupivacaine mixture registered as the time until the first dose of morphine is taken, and when the pain score is above 3 and located to the frontal or medial side of the ankle. Morphine is administered intravenously by a patient controlled pump, (PCA - Patient Controlled Analgesia), which will give a specific dose when the patient pushes the button. The patients will be thoroughly instructed in the use of the pump prior to the operation and the importance of scoring their pain and indicating the localization if they want to take a dose of morphine is underlined. ;Timepoint(s) of evaluation of this end point: The timepoint for the primary end point is the exact time where the first bolus of morphine is taken by the patient. This timepoint is registered by the PCA pump and will be within the first 48 hours after surgery.	—

Measure

Time frame

Main Objective: The main objective is to investigate whether addition of the adjuvant dexamethasone to bupivacaine-adrenaline can prolong the analgesic effect of the saphenous block compared to plain bupivacaine-adrenaline in patients after major ankle and hind foot surgery. ;Secondary Objective: - Compare the cumulated opioid consumption during the first 48 hours after surgery - Compare pain scores during the first 48 hours after surgery - Investigate the localization of the pain during the first 48 hours after surgery ;Primary end point(s): Duration of the saphenous nerve block with plain vs. protracted bupivacaine mixture registered as the time until the first dose of morphine is taken, and when the pain score is above 3 and located to the frontal or medial side of the ankle. Morphine is administered intravenously by a patient controlled pump, (PCA - Patient Controlled Analgesia), which will give a specific dose when the patient pushes the button. The patients will be thoroughly instructed in the use of the pump prior to the operation and the importance of scoring their pain and indicating the localization if they want to take a dose of morphine is underlined. ;Timepoint(s) of evaluation of this end point: The timepoint for the primary end point is the exact time where the first bolus of morphine is taken by the patient. This timepoint is registered by the PCA pump and will be within the first 48 hours after surgery.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Cumulated opioid consumption is registered 48 hours after surgery Pain score, pain localization and sensory tests are performed at regular time intervals: Arrival at and departure from the Perioperative Section and 6, 12, 24, 30, 36, 42 and 48 hours after surgery. ;Secondary end point(s): - Cumulated opioid consumption registered by the PCA pump - Pain score on the NRS (Numeric ranking scale) with values from 0 to 10. Pain scoring is done at rest because the patient's leg is elevated on a Kirschner splint. It is the maximal pain since the last score, which is evaluated. - Pain localization - Test of sensory blockade of the peroneal, tiabial and saphenous nerve. The sensory blockade of the peroneal nerve is tested on the dorsal side of the toes and the tibial nerve on the plantar side of the toes. The saphenous territory at the medial side of the lower leg is covered in a cast, and therefore the orthopaedist will make a small window in the cast to enable testing.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Cumulated opioid consumption is registered 48 hours after surgery Pain score, pain localization and sensory tests are performed at regular time intervals: Arrival at and departure from the Perioperative Section and 6, 12, 24, 30, 36, 42 and 48 hours after surgery. ;Secondary end point(s): - Cumulated opioid consumption registered by the PCA pump - Pain score on the NRS (Numeric ranking scale) with values from 0 to 10. Pain scoring is done at rest because the patient's leg is elevated on a Kirschner splint. It is the maximal pain since the last score, which is evaluated. - Pain localization - Test of sensory blockade of the peroneal, tiabial and saphenous nerve. The sensory blockade of the peroneal nerve is tested on the dorsal side of the toes and the tibial nerve on the plantar side of the toes. The saphenous territory at the medial side of the lower leg is covered in a cast, and therefore the orthopaedist will make a small window in the cast to enable testing.

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Countries

Denmark

Contacts

Public ContactDep. Anaesthesia and Intensive Care

Aarhus University Hospital

tfb@dadlnet.dk+4551542997

Outcome results

None listed

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

Post-operative pain treatment of patients after major ankle and foot surgery by comparing a nerve block with plain local anesthetic to a new protracted mixture of local anesthetics.

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Outcome results