Postoperative pain after hip arthroscopy MedDRA version: 21.0 Level: LLT Classification code 10080604 Term: Hip arthroscopy System Organ Class: 100000004848
Conditions
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
Concentra
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Set for elective primary hip arthroscopy by one single orthopedic surgeon • Scheduled general anesthesia with Propofol and Remifentanil • ASA I-III • Patient = 18 years • 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 35 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 forms of communication problems • Allergy to local analgesics used in the study (Marcain + Adrenaline). • Lack of tolerance to both Morphine and Oxycodone • Chronic pain with daily opioid consumption (dosed > 1day) • Treatment with antipsychotics • Known abuse of alcohol or medication • Previous hip surgery • 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 subpectineal obturatorius nerve block for elective primary hip arthroscopy. The primary objective of the study is to investigate morphine consumption;Secondary Objective: The secondary goals are to investigate pain and morphine side effects. ;Primary end point(s): Cumulated opioid consumption by PCA pump (patient controlled analgesia) for the first 180 min in PACU (Post operative care unit) after primary hip arthroscopy for patients with active or placebo subpectineal obturatorius nerve block.;Timepoint(s) of evaluation of this end point: 180 min after arrival to PACU | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Assessed upon arrival at PACU and then every 30 min. the next 180 min. where the patient remains in the PACU. (Time 0, 30, 60, 90, 120, 150, 180 min);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 upon arrival at PACU and then every 30 min. the next 180 min. where the patient remains in the PACU. • Pain score (NRS 0-10) in the hip at activity (flexion of the hip joint to 45 degrees) assessed upon arrival at the PACU and then every 30 minutes. the next 180 min. where the patient remains in the PACU. • Nausea score assessed on a scale (none, light, moderate, pronounced) assessed upon arrival at PACU and then every 30 min. the next 180 min. where the patient remains in the PACU. • Number of vomiting in the first 180 min. the patient is in the PACU. • Duration of stay (LOS) measured in minutes in PACU. The end time for LOS on the Observation section is recorded at the time the patient meets DASAIM's criteria for discharge from the PACU. After the first 180 min in the PACU, this is assessed every 30 min where the patient remains in the PACU. • Total morphine consumption in PACU during the first 180 min in PACU. • The force of the hip adductor muscles on the operated lower extremities is tested with a dynamometer after 180 min. • Patient satisfaction with the pain management at the time of discharge (NRS 0-10, where 0 is very dissatisfied and 10 is very satisfied). | — |
Countries
Denmark
Contacts
Public ContactThomas Fichtner Bendtsen
Aarhus University Hospital
Outcome results
None listed