The effect of anesthetizing the small nerve to the ankle joint on postoperative pain following major ankle surgery

The effect of subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000608-27-DK

Enrollment

Unknown

Registered

2016-02-16

Start date

2016-04-05

Completion date

Unknown

Last updated

2017-06-05

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

Conditions

Post-operative pain after four types of major ankle and hind foot surgery: (1) total ankle arthroplasty, (2) ankle arthrodesis, (3) subtalar arthrodesis or (4) triple arthrodesis MedDRA version: 19.0 Level: LLT Classification code 10003396 Term: Arthroplasty NOS System Organ Class: 100000004865 MedDRA version: 19.0 Level: LLT Classification code 10016962 Term: Foot arthrodesis System Organ Class: 100000004865 MedDRA version: 19.0 Level: LLT Classification code 10002540 Term: Ankle arthrodesi

Interventions

Trade Name: Marcain-Adrenalin Product Name: Marcain-Adrenalin Pharmaceutical Form: Solution for injection INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE Other descriptive name: BUPIVACAINE HYDROCHLORI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Elective ankle or hind foot surgery either (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis, (4) triple 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 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9

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 - 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 conduct a prospective, randomized, controlled, double-blinded trial to compare subsartorial saphenous block with bupivacaine-adrenaline vs. placebo to investigate the effect of a saphenous block as a supplement to a continious sciatic catheter on postoperative pain following major ankle surgery. ;Secondary Objective: Sensory test of the infrapatellar branch as a proxy marker for analgesia of the saphenous nerve. ;Primary end point(s): The frequency of patients who report significant pain at rest (NRS > 3);Timepoint(s) of evaluation of this end point: Pain scores are evaluated 8 times during the 2 hours observation period. The observation period starts when the surgery is completed. This time is noted in the electronic patient file = t0 The test times are: At arrival at the Perioperative Section and at t = 30 min, t = 60 min t = 75 min, t = 90 min, t = 105 min, t = 120 min	—

Measure

Time frame

Main Objective: The main objective is to conduct a prospective, randomized, controlled, double-blinded trial to compare subsartorial saphenous block with bupivacaine-adrenaline vs. placebo to investigate the effect of a saphenous block as a supplement to a continious sciatic catheter on postoperative pain following major ankle surgery. ;Secondary Objective: Sensory test of the infrapatellar branch as a proxy marker for analgesia of the saphenous nerve. ;Primary end point(s): The frequency of patients who report significant pain at rest (NRS > 3);Timepoint(s) of evaluation of this end point: Pain scores are evaluated 8 times during the 2 hours observation period. The observation period starts when the surgery is completed. This time is noted in the electronic patient file = t0 The test times are: At arrival at the Perioperative Section and at t = 30 min, t = 60 min t = 75 min, t = 90 min, t = 105 min, t = 120 min

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Secondary

Measure	Time frame
Secondary end point(s): Sensory testing of the infrapatellar branch. The skin is tested in an area from the medial femoral condyle to the midline between the apex of patella and the tibial tuberosity. ;Timepoint(s) of evaluation of this end point: Sensory testing is conducted when the patient reports significant pain (NRS >3) If the patient does not experience any pain during the observation period, sensory testing is conducted at the end of the observation period, t = 120 min	—

Measure

Time frame

Secondary end point(s): Sensory testing of the infrapatellar branch. The skin is tested in an area from the medial femoral condyle to the midline between the apex of patella and the tibial tuberosity. ;Timepoint(s) of evaluation of this end point: Sensory testing is conducted when the patient reports significant pain (NRS >3) If the patient does not experience any pain during the observation period, sensory testing is conducted at the end of the observation period, t = 120 min

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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