Posteoperative shoulder pain following open liver resection surgery . MedDRA version: 19.0 Level: LLT Classification code 10024717 Term: Liver tumor System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Ropivacain "Fresenius Kabi" 7,5 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROPIVACAINE
CAS Number: 84057-95-4
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Jens Hilligsø
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age above 18. Patients scheduled for liver resection. Ability to giive 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Participation in another clinical trial, dealing with pain or management of pain, which could affect this trial, evaluated by the investigator. Inability to talk and understand danish Drug or alcohol abuse Pregnancy Congestive heart failure (NYHA class III-IV), or other serious heart disease. Chronic obstructive lung disease, moderate or severe degree, or other significant lung disease Chronic or acute shoulder pain prior to surgery. Body Mass Index above 35. Infection at the site of the injection Allergy to ropivacaine Postoperativ: Shoulder pain score < 6 assessed on the numeric rating scale (0-10), 15 minutes after arrival in postanaesthetic care unit (PA CU). Insufficient epidural analgesia, or lack of epidural analgesia. Inability to visualize nervus phrenicus with sonography. Cerebral confusion, postoperative delirium or other medical condition hindering study intervention. Presence of an investigator with intervention competence is not available.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore whether the use of ultrasound guided phrenic nerve block can reduce the postoperative pain in the shoulder after liver resection. The intervention is directed postoperative to the patients experiencing novel right sided shoulder pain.;Secondary Objective: To evaluate lung function in relation to a unilateral phrenic nerve block. To evaluate duration of liver resection surgery in relation to postoperative pain in the shoulder.;Primary end point(s): Reduction in pain score of a minimum of 3 NRS ( =numerical rating scale 0-10) points when baseline pain score is compared to pain score after 1st intervention. ;Timepoint(s) of evaluation of this end point: 15 minutes after 1st intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Reduction in pain score of a minimum of 3 NRS points, when pain score just prior to the 1st intervention (baseline) is compared to pain score after 1st intervention or 2nd intervention. Lung function evaluated with spirometry (FEV1, FVC og VC) just prior to 1st intervention (baseline), compared to lung function after 1st intervention or 2nd intervention. Lung function evaluated with arterial blood gas (paO2, paCO2) just prior to 1st intervention (baseline), compared to lung function after 1st intervention or 2nd intervention. Duration of surgery compared to shoulderpain just prior to 1st intervention. Number of included patients with a pain score (NRS) between 0 and 3 after 1st intervention or 2nd intervention. Number of included patients with respiratory affection, if defined as this in the medical chart. Number of included patients treated with opioid and the amount of used opioid in morphine equivalence. Prevalence of respiratory og cardiovascular events until discharge when defined as this in medical chart and prevalence of readmission obtained from the Danish National Hospital Registry. ;Timepoint(s) of evaluation of this end point: Pain score 2, 5, 10, 60 minutes and 24h after 1st intervention and 2, 5, 10 and 15 minutes after 2nd intervention. Lung function (arterial blood gas and spirometry) just prior to 2nd intervention (15 minutes after 1st intervention), 60 minutes after 1st intervention and 15 minutes after 2nd intervention. Respiratory og cardiovascular affection within 24 hours postoperative. Pain score (NRS) between 0 and 3 evaluated 5 and 15 minutes after 1st intervention or 2nd intervention Number of included patients with respiratory affection within the first 24 hours. Respiratory og cardiovascular events until discharge when defined as this in medical chart and prevalence of readmission within 30 days after inclusion. | — |
Countries
Denmark
Contacts
Public ContactDep. of Gartroenterology
Department of Gastroenterology, Rigshospitalet
Outcome results
None listed