The effect of phrenic nerve block on postoperative shoulder pain in patients for liver resection – a double blinded randomised controlled trial.

Phase 1

• Conditions: Posteoperative shoulder pain following open liver resection surgery .; MedDRA version: 19.0Level: LLTClassification code 10024717Term: Liver tumorSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-004649-18-DK
• Lead Sponsor: Jens Hilligsø

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-17
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br><br>