Open heart surgery – does it have to hurt that much? Does a continuous infusion of local anaesthetic on either side of the chest wound result in better pain relief and recovery after open heart surgery compared to current treatment?

Open heart surgery – does it have to hurt that much? PACS – Parasternal After Cardiac Surgery. A prospective randomised study to assess the analgesic effect of a continuous bilateral parasternal block with lidocaine after sternotomy. - PACS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004672-35-SE

Enrollment

Registered

2019-09-27

Start date

2020-01-10

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The analgesic effect of continuous bilateral parasternal infusion of local anaesthetic after open cardiac surgery.

Interventions

Trade Name: Xylocain Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Other use (Noncu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age 20 to 80 years • ASA 2-3 (American Society of Anesthesiologists) Physcial Status Class 2-3 • 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: • Emergency surgery • Redo sternotomy • Preoperative severe left heart failure • Preoperative respiratory insufficiency • Preoperative advanced kidney failure • Pronounced hepatic disease • Allergy to local anaesthetic • Psychiatric disease or any psychoactive medication • Cognitive disturbance and/or inability to understand written and/or oral instructions • History of chronic pain or chronic pain medication • Failure to be extubated within 4 hours after surgery • Deep hypothermia during surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: The study will test the hypothesis that a continuous bilateral parasternal block with lidocaine will decrease postoperative pain after sternotomy for open cardiac surgery. ;Secondary Objective: The study will evaluate whether improved analgesia by a continuous parasternal block will increase postoperative recovery.;Primary end point(s): Cumulated intravenous PCA (Patient Controlled Analgesia) morphine consumption at 72 hours ;Timepoint(s) of evaluation of this end point: After 72 hours	—

Measure

Time frame

Main Objective: The study will test the hypothesis that a continuous bilateral parasternal block with lidocaine will decrease postoperative pain after sternotomy for open cardiac surgery. ;Secondary Objective: The study will evaluate whether improved analgesia by a continuous parasternal block will increase postoperative recovery.;Primary end point(s): Cumulated intravenous PCA (Patient Controlled Analgesia) morphine consumption at 72 hours ;Timepoint(s) of evaluation of this end point: After 72 hours

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Secondary

Measure	Time frame
Secondary end point(s): • Cumulated NRS (Numeric Rating Scale) score for pain every 8 hours at 72 hours • QoR-15 (Quality of Recovery questionnaire) score at 24,48 and 72 hours as well as 2, 4, 8 and 12 weeks after surgery • NRS at rest at all time points during initial 72 hours • NRS score at rest and in movement at 2, 4, 8 and 12 weeks after surgery • Morphine consumption at 24, 48 and 72 hours • Oxycodon requirement at 2, 4, 8 and 12 weeks after surgery • Cumulated NRS after two deep breaths three times daily, during 72 hours • NRS after two deep breaths three times daily, during 72 hours • NRS at rest and after two deep breaths at 2, 4, 8 and 12 weeks after surgery • Incidence of nausea and/or vomiting at any time during initial 72 hours • Incidence of sedation at any time during initial 72 hours • Incidence of arrhythmia, more than single or solitary coupled supraventricular and ventricular extra beats at any time during initial 72 hours • Spirometry preoperatively, and then postoperatively at the morning after surgery and in the evening from day after surgery until postoperative day 3 • Plasma levels of stress markers and lidocaine 1, 24, 48 and 72 hours postoperatively compared to preoperative values • Day of discharge and discharge time ; Timepoint(s) of evaluation of this end point: Please see E.5.2	—

Measure

Time frame

Secondary end point(s): • Cumulated NRS (Numeric Rating Scale) score for pain every 8 hours at 72 hours • QoR-15 (Quality of Recovery questionnaire) score at 24,48 and 72 hours as well as 2, 4, 8 and 12 weeks after surgery • NRS at rest at all time points during initial 72 hours • NRS score at rest and in movement at 2, 4, 8 and 12 weeks after surgery • Morphine consumption at 24, 48 and 72 hours • Oxycodon requirement at 2, 4, 8 and 12 weeks after surgery • Cumulated NRS after two deep breaths three times daily, during 72 hours • NRS after two deep breaths three times daily, during 72 hours • NRS at rest and after two deep breaths at 2, 4, 8 and 12 weeks after surgery • Incidence of nausea and/or vomiting at any time during initial 72 hours • Incidence of sedation at any time during initial 72 hours • Incidence of arrhythmia, more than single or solitary coupled supraventricular and ventricular extra beats at any time during initial 72 hours • Spirometry preoperatively, and then postoperatively at the morning after surgery and in the evening from day after surgery until postoperative day 3 • Plasma levels of stress markers and lidocaine 1, 24, 48 and 72 hours postoperatively compared to preoperative values • Day of discharge and discharge time ; Timepoint(s) of evaluation of this end point: Please see E.5.2

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Countries

Sweden

Contacts

Public ContactMark Larsson

Karolinska University Hospital, Dep of Cardiothoracic Anesthesia and Intensive Care

mark.larsson@sll.se46851770914

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026