The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection.

Surgery Clinical Trial

Official title:

The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection - a Double Blinded Randomised Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02903719
• Other study ID #: 13001
• Status: Recruiting
• Phase: Phase 4
• First received: September 13, 2016
• Last updated: September 22, 2016
• Start date: September 2016
• Est. completion date: April 2017

Study information

• Verified date: September 2016
• Source: Rigshospitalet, Denmark
• Contact: Søren Mr Bøgevig, MD
• Phone: 0045 20 66 40 51
• Email: soeren.boegevig.03[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The aim of this study is 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.

Description:

Background:

Patients undergoing both laparoscopic and open hepatic surgery often experience shoulder pain in the postoperative period, mostly on the right side.

The mechanism behind referral of pain from surgical sites to the ipsilateral (same side) shoulder is not fully understood. It has been stated, that the sharing of cervical sensory roots, leads the brain to an interpretation that the pain as originating from the ipsilateral shoulder, when the phrenic nerve is stimulated.

The phrenic nerve provides both sensory and motor nerves to the diaphragm, and sensory fibers to parts of the pleura and peritoneum. Furthermore, one anatomical study indicate, that the phrenic nerve on the right side supply the liver capsule with thin sensory nerves. This could also, in part, explain the shoulder pain after liver surgery.

Studies assessing the effect of phrenic block on shoulder pain by surgically applied intrathoracic block of the phrenic nerve, have found a pain reduction, without significant side effects. There are no available studies on the effect of phrenic nerve block after hepatic surgery. Blocking the nerve intraoperatively, as described in thoracic surgery, is not possible during these operations.

Pilot study of the incidence: A recent survey at Rigshospitalet, Denmark, revealed, that 19 out of 60 patients undergoing various types of hepatic surgery, experienced moderate to severe right sided shoulder pain in the post operative care unit. The only semi-effective treatment, has been opioids (morphine), often leading to significant side effects (nausea, vomiting , dizziness) with a potential for an increase in postoperative morbidity. Furthermore, referred shoulder pain affects the respiratory capacity postoperatively.

The investigators have developed a method for applying ultrasound-guided block at the lateral side of the neck, directly at the phrenic nerve where it crosses over the scaleni anterior muscle. The block is done with low volume of local anesthetic (only 3 ml very close to the nerve) aiming to avoid affection of the brachial plexus.

The phrenic nerve block have been performed at right sided shoulder pain in the postoperative care unit with marked effect within a few minutes (small nerve with little perineural insulation).

Trial endpoints:

The idea of the study is to perform a precise, low volume, ultrasound guided nerve block in the patients who experience a severe right sided shoulder pain (NRS >5 on a 0-10 scale) after liver surgery and evaluate the effect of active substance vs. placebo

Furthermore the investigators wish to stablish an evaluation of the duration of the phrenic nerve block when it comes to pain intensity, incidence of referred shoulder pain after liver surgery, and need for opioid and to evaluate the effect of the block on the lung function.

The study results will be described in a primary publication regarding the primary outcome, and a secondary publication regarding the incidence of acute respiratory and ventilatory affection observed in the PACU in patients undergoing open liver resection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18.

• Patients scheduled for liver resection.

• Ability to give informed consent.

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

Postoperative:

• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nerve Block
• Shoulder Pain
• Surgery

Intervention

Drug:
• Ropivacaine
All included patients with a right sided shoulder pain score on a numeric rating scale (NRS) equal to or above 6 and without postoperative exclusion criteria will have two (1st and 2nd intervention) ultrasound guided phrenic nerve blocks performed.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Eske Kvanner Aasvang

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measurements on a NRS (Numeric Rating Scale)	Patients are asked to rate the intensity of their shoulder pain (if any) according to NRS (Numeric Rating Scale) from 0-10 (0=no pain, 10=the worst pain imaginable). For patients receiving the intervention they are asked to rate the intensity of their pain 15 minutes after the 1st intervention.	1 hour	No
Secondary	Lung function assessed by Spirometry	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. Patients receiving the interventions get their lung function measured 3 times after the interventions. Patients excluded postoperatively get their lung function measured once.	1 day	No
Secondary	Lung function assessed by arterial blood gas	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. Lung function is also evaluated with arterial blood gas one hour after 2nd intervention.	1 hour	No
Secondary	Duration of surgery compared to shoulder pain	Duration of surgery compared to shoulder pain just prior to 1st intervention. The intensity of pain is measured according to NRS (0-10, 0=no pain, 10=worst pain imaginable).	1 hour	No
Secondary	Number of included patients with low pain score (NRS) after interventions.	Number of included patients with a pain score (NRS) between 0 and 3 after 1st intervention or 2nd intervention.	1 hour and 15 minutes	No
Secondary	Number of patients with respiratory affection	Number of included patients with respiratory affection, if defined as this in the medical chart.	1 day	No
Secondary	Number os patients treated with opioid	Number of included patients treated with opioid and the amount of used opioid in morphine equivalence.	2 hours	No
Secondary	Prevalence of respiratory and cardiovascular events amon included and excluded patients.	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.	30 days	No
Secondary	Pain measurements 24 hours after the 1st intervention.	Patients are asked to rate the intensity of their shoulder pain according to NRS (numeric rating scale 0-10) 24 hours after the 1st intervention.	24 hours	No
Secondary	Pain measurements on a NRS (Numeric Rating Scale)	Patients are asked to rate the intensity of their shoulder pain (if any) according to NRS (Numeric rating scale) from 0-10 (0=no pain, 10=the worst pain imaginable). For patients receiving the intervention they are asked to rate the intensity of their pain +2, +5, +10 and +60 minutes after the 1st intervention and +2, +5, +10 and +15 after the 2nd intervention.	2 hours	No