The effect of a new technique for anesthetizing the nerves involved in pain after repair of the anterior cruciate ligament in the knee.

The effect of the popliteal plexus block on postoperative pain after reconstruction of the anterior cruciate ligament

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001708-31-DK

Enrollment

100

Registered

2017-04-25

Start date

2017-06-20

Completion date

Unknown

Last updated

2018-01-29

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

Conditions

Postoperative pain after reconstruction of the anterior cruciate ligament MedDRA version: 20.0 Level: LLT Classification code 10078191 Term: Anterior cruciate ligament reconstruction System Organ Class: 100000021343

Interventions

Trade Name: Marcain-adrenalin 5 mg/ml + 5 mikrogram/ml Product Name: Marcain-adrenalin Pharmaceutical Form: Solution for injection INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients undergoing ACL reconstruction on one of the two trial sites - Age = 18 - ASA I-III - 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients unable to cooperate - Patients not able to speak Danish or with other communication problems - Pregnancy - Contraindication towards any medical product used in the study - Preoperatively reduced sensation on the medial and lateral part of the lower leg - Patients with diabetes requiring medical treatment - Preoperative intake of opioids (dosed > once daily) - ACL revision

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this pilot study is to investigate the effect of the popliteal plexus block (PPB) as a supplement to femoral triangle block (FTB) after reconstruction of the anterior cruciate ligament.;Secondary Objective: The secondary objectives of the pilot study are: testing of the set-up for the following randomized clinical trial (RCT), length of observation periods, test methods, data collection for the power estimation for the RCT.;Primary end point(s): The effect of the PPB evaluated as the percentage of patients with postoperative pain NRS >3 dropping in pain score to NRS = 3 after the PPB ;Timepoint(s) of evaluation of this end point: Pain scores (NRS) are evaluated 15, 30, 45 and 60 minutes after the PPB.	—

Measure

Time frame

Main Objective: The main objective of this pilot study is to investigate the effect of the popliteal plexus block (PPB) as a supplement to femoral triangle block (FTB) after reconstruction of the anterior cruciate ligament.;Secondary Objective: The secondary objectives of the pilot study are: testing of the set-up for the following randomized clinical trial (RCT), length of observation periods, test methods, data collection for the power estimation for the RCT.;Primary end point(s): The effect of the PPB evaluated as the percentage of patients with postoperative pain NRS >3 dropping in pain score to NRS = 3 after the PPB ;Timepoint(s) of evaluation of this end point: Pain scores (NRS) are evaluated 15, 30, 45 and 60 minutes after the PPB.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1) Pain scores: 15, 30, 45 and 60 minutes after t0 (t0 = arrival at the PACU) 2) Time from withdrawal of the needle until patient reports NRS = 3) 3) Sensory test: Baseline, 30 and 60 minutes after PPB 4) Muscle strength: Baseline, 60 minutes after PPB ;Secondary end point(s): 1) The percentage of patients with FTB reporting pain (NRS >3) not localized to the graft donor site in the observation period 2) Onset time for PPB 3) The effect of the PPB on cutaneous sensation on the lateral part of the lower leg (pinprick test) 4) The effect of the PPB on muscle strength (dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 1) Pain scores: 15, 30, 45 and 60 minutes after t0 (t0 = arrival at the PACU) 2) Time from withdrawal of the needle until patient reports NRS = 3) 3) Sensory test: Baseline, 30 and 60 minutes after PPB 4) Muscle strength: Baseline, 60 minutes after PPB ;Secondary end point(s): 1) The percentage of patients with FTB reporting pain (NRS >3) not localized to the graft donor site in the observation period 2) Onset time for PPB 3) The effect of the PPB on cutaneous sensation on the lateral part of the lower leg (pinprick test) 4) The effect of the PPB on muscle strength (dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer)

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Countries

Denmark

Contacts

Public ContactDepartment of Anesthesia

Aarhus University Hospital

tfb@dadlnet.dk+4551542997

Outcome results

None listed

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