The effect of iliopsoas plane block on opioid consumption and pain after hip arthroscopy

The effect of iliopsoas plane block on opioid consumption and pain after hip arthroscopy A double-blind randomized, controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005838-15-DK

Enrollment

Registered

2021-01-15

Start date

2021-03-22

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Postoperative pain after hip arthroscopy MedDRA version: 21.0 Level: LLT Classification code 10080604 Term: Hip arthroscopy System Organ Class: 100000004848

Interventions

Trade Name: Marcain-Adrenalin Product Name: Marcain-Adrenalin Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: BUPIVACAINE CAS Number: 2180-92-9 Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Set for elective primary hip arthroscopy by one single otrhopedic surgeon • Planned generel anesthesia with Propofol og Remifentanil • ASA I-III • Patient = 18 years • Informeret 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • Inability to cooperate • Unable to speak and/or understand Danish or other types of communication problems • Allergy to local analgesics in the study (Marcain + adrenaline) • Lack of tolerance of both Morphine and Oxycodone • Chronic pain with daily opioid consumption (dosed > x 1Day) • Chronic pain and treatment with gabapentin, pregabalin, tricyclic antidepressants, opioid antagonists or SNRI • Treatment with antipsychotics • Known abuse of alcohol, drugs or medicine • Previous hip surgery on the planned site for this hip artroscopy • Previous participation in this study • Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of the trial is to assess the analgesic effect of preoperatively placed active or placebo iliopsoas plane block for elective primary hip arthroscopy. The primary objective of the study is to investigate morphine consumption;Secondary Objective: The secondary goal are to investyigate pain and morphine side effects. ;Primary end point(s): Cumulative opioid consumption by PCA pump (patient controlled analgesia) in the first 180 min in PACU after primary hip arthroscopy for patients with active or placebo iliopsoas plane blockade.;Timepoint(s) of evaluation of this end point: 180 min. after arrival to PACU	—

Measure

Time frame

Main Objective: The purpose of the trial is to assess the analgesic effect of preoperatively placed active or placebo iliopsoas plane block for elective primary hip arthroscopy. The primary objective of the study is to investigate morphine consumption;Secondary Objective: The secondary goal are to investyigate pain and morphine side effects. ;Primary end point(s): Cumulative opioid consumption by PCA pump (patient controlled analgesia) in the first 180 min in PACU after primary hip arthroscopy for patients with active or placebo iliopsoas plane blockade.;Timepoint(s) of evaluation of this end point: 180 min. after arrival to PACU

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Secondary

Measure	Time frame
Secondary end point(s): • Pain Score (NRS 0-10, where 0 is no pain and 10 the worst possible pain) in the hip at rest assessed on arrival at PACU and then every 30 minutes the next 180 min. where the patient remains in PACU. • Pain Score (NRS 0-10) in the hip by activity (flexion at the hip joint to 45 degrees), assessed on arrival at PACU and then every 30 minutes the next 180 min. where the patient remains in PACU. • Nausea score assessed on a scale (no, mild, moderate, pronounced) assessed on arrival at PACU and then every 30 minutes the next 180 min. where the patient remains in PACU. • Number of vomiting the first 180 min. The patient is in PACU. • Length of stay (LOS) measured in minutes in PACU. The period is registered from arrival to PACU until the patient is ready for discharge. After the first 180 min in PACU, this is assessed every 30 minutes where the patient remains in PACU. • Total morphine consumption in PACU during the first 180 min in PACU. • The force of the quadriceps muscles on the operated limb was tested with a dynamometer before the nerve blockade and after 180 min observation in PACU. • Patient satisfaction with pain treatment at the time of discharge (NRS 0-10, where 0 is very dissatisfied and 10 is very satisfied).;Timepoint(s) of evaluation of this end point: Assessed upon arrival at PACU and the every 30 min the next 180 min where the patient remains in the PACU	—

Measure

Time frame

Secondary end point(s): • Pain Score (NRS 0-10, where 0 is no pain and 10 the worst possible pain) in the hip at rest assessed on arrival at PACU and then every 30 minutes the next 180 min. where the patient remains in PACU. • Pain Score (NRS 0-10) in the hip by activity (flexion at the hip joint to 45 degrees), assessed on arrival at PACU and then every 30 minutes the next 180 min. where the patient remains in PACU. • Nausea score assessed on a scale (no, mild, moderate, pronounced) assessed on arrival at PACU and then every 30 minutes the next 180 min. where the patient remains in PACU. • Number of vomiting the first 180 min. The patient is in PACU. • Length of stay (LOS) measured in minutes in PACU. The period is registered from arrival to PACU until the patient is ready for discharge. After the first 180 min in PACU, this is assessed every 30 minutes where the patient remains in PACU. • Total morphine consumption in PACU during the first 180 min in PACU. • The force of the quadriceps muscles on the operated limb was tested with a dynamometer before the nerve blockade and after 180 min observation in PACU. • Patient satisfaction with pain treatment at the time of discharge (NRS 0-10, where 0 is very dissatisfied and 10 is very satisfied).;Timepoint(s) of evaluation of this end point: Assessed upon arrival at PACU and the every 30 min the next 180 min where the patient remains in the PACU

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Countries

Denmark

Contacts

Public ContactThomas Fichtner Bendtsen

Aarhus University Hospital

tfb@dadlnet.dk+4551542997

Outcome results

None listed

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