A Phase 4 interventional study of Ropivacaine in Shoulder Pain, Surgery and Nerve Block, sponsored by Eske Kvanner Aasvang. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.
Sponsored by Eske Kvanner Aasvang · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Postoperative:
1. st intervention: A single ultrasound guided perineural injection of Ropivacaine 7,5 mg/ml, 3 ml 2. nd intervention (approx. 15 minutes after 1st intervention): A single ultrasound guided perineural injection of isotonic saline solution 9 mg/ml, 3 ml
Drug: Ropivacaine
1. st Intervention: A single ultrasound guided perineural injection of isotonic saline solution 9 mg/ml, 3 ml 2. nd Intervention (approx. 15 minutes after 1st intervention):A single ultrasound guided perineural injection of Ropivacaine 7,5 mg/ml, 3 ml
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.
Also known as: Naropin
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.
Time frame: 1 hour
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.
Time frame: 1 day
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.
Time frame: 1 hour
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).
Time frame: 1 hour
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.
Time frame: 1 hour and 15 minutes
Number of patients with respiratory affection
Number of included patients with respiratory affection, if defined as this in the medical chart.
Time frame: 1 day
Number os patients treated with opioid
Number of included patients treated with opioid and the amount of used opioid in morphine equivalence.
Time frame: 2 hours
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.
Time frame: 30 days
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.
Time frame: 24 hours
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.
Time frame: 2 hours
Plan to share: Undecided
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Eske Kvanner Aasvang