NCT03901612

Brief Summary

Fast track to Extubation after cardiothoracic surgery is becoming more common after a number of reports showing it is safe and effective. However, It has introduced new challenges to pain control. Intubated patients require larger doses of opioids and benzodiazepines for comfort. In patients who are awake and spontaneously breathing, pain and agitation cannot be treated with lower doses. Some centers still administer continuous infusions of opioid and benzodiazepines to extubated patients. These infusions may not be necessary and may even be harmful. The recent pilot study (In press in Journal of cardio thoracic vascular anesthesia ) in our Vinmec hospitals performing open heart surgeries of peri-operative regional analgesia by Continuous Bilateral Erector Spinae Plane Blocks in adult showed that the pain relief was efficient and the requirement for opioids was zero in post-operative period. It confirmed that the impact of regional anesthesia techniques on main procedure-specific postoperative outcomes is very important in opioids decreased use in the context of fast-track programs that are fully suggested after cardiac surgery. In April 2017 we introduced the technique of ESP block for open heart surgeries in Adults and in pediatric. At the beginning we performed single shot block and the patients still needed during around 30 to 40 hours small doses of opioids to release their pain according to the evaluation by Comfort-B,FLACC VAS Scales. Since we are performing continuous peri-operative regional analgesia by Bilateral ESP catheters the requirement for additional opioids to release the pain is zero based on our practice of 480 ESP catheters for open heart surgeries. We would like to compare the 2 analgesic techniques and analyze the post operative opioid consumption, the quality of recovery and the quality of life after the surgery.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

4.6 years

First QC Date

April 2, 2019

Last Update Submit

August 15, 2023

Conditions

Post Operative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Morphine consumption in milligrams

    From extubation to 48 hours after end of surgery

Secondary Outcomes (3)

  • Quality of recovery after the surgery

    48 hours after end of surgery

  • Quality of Life after the surgery

    30 days after end of surgery

  • post operative pain

    every 6 hours during 48hours after the end of the surgery

Study Arms (2)

Saline solution

PLACEBO COMPARATOR

Post operative analgesia throw the thoracic Erector spinae catheter with saline solution and opioid rescue

Drug: saline 09%

Ropivacaine

EXPERIMENTAL

Post operative analgesia throw the thoracic Erector spinae catheter with Ropivacaine 0.2% solution and opioid rescue

Drug: Ropivacaine 0.2%

Interventions

Ropivacaine 0.2%DRUG

Continuous post operative regional analgesia

Ropivacaine
saline 09%DRUG

Continuous post operative regional analgesia

Saline solution

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients having an elective open heart surgery

You may not qualify if:

  • refusal of the patient allergy to local anesthetics instable patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VinMec INternational hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (8)

  • Alghamdi AA, Singh SK, Hamilton BC, Yadava M, Holtby H, Van Arsdell GS, Al-Radi OO. Early extubation after pediatric cardiac surgery: systematic review, meta-analysis, and evidence-based recommendations. J Card Surg. 2010 Sep;25(5):586-95. doi: 10.1111/j.1540-8191.2010.01088.x.

    PMID: 20626510BACKGROUND

  • Garg R, Rao S, John C, Reddy C, Hegde R, Murthy K, Prakash PV. Extubation in the operating room after cardiac surgery in children: a prospective observational study with multidisciplinary coordinated approach. J Cardiothorac Vasc Anesth. 2014 Jun;28(3):479-87. doi: 10.1053/j.jvca.2014.01.003. Epub 2014 Apr 18.

    PMID: 24746595BACKGROUND

  • Heinle JS, Diaz LK, Fox LS. Early extubation after cardiac operations in neonates and young infants. J Thorac Cardiovasc Surg. 1997 Sep;114(3):413-8. doi: 10.1016/S0022-5223(97)70187-9.

    PMID: 9305193BACKGROUND

  • Kin N, Weismann C, Srivastava S, Chakravarti S, Bodian C, Hossain S, Krol M, Hollinger I, Nguyen K, Mittnacht AJ. Factors affecting the decision to defer endotracheal extubation after surgery for congenital heart disease: a prospective observational study. Anesth Analg. 2011 Aug;113(2):329-35. doi: 10.1213/ANE.0b013e31821cd236. Epub 2011 Apr 13.

    PMID: 21490084BACKGROUND

  • Carli F, Kehlet H, Baldini G, Steel A, McRae K, Slinger P, Hemmerling T, Salinas F, Neal JM. Evidence basis for regional anesthesia in multidisciplinary fast-track surgical care pathways. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):63-72. doi: 10.1097/AAP.0b013e31820307f7.

    PMID: 22002193BACKGROUND

  • Macaire P, Ho N, Nguyen T, Nguyen B, Vu V, Quach C, Roques V, Capdevila X. Ultrasound-Guided Continuous Thoracic Erector Spinae Plane Block Within an Enhanced Recovery Program Is Associated with Decreased Opioid Consumption and Improved Patient Postoperative Rehabilitation After Open Cardiac Surgery-A Patient-Matched, Controlled Before-and-After Study. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1659-1667. doi: 10.1053/j.jvca.2018.11.021. Epub 2018 Nov 19.

    PMID: 30665850BACKGROUND

  • Tsui BCH, Navaratnam M, Boltz G, Maeda K, Caruso TJ. Bilateral automatized intermittent bolus erector spinae plane analgesic blocks for sternotomy in a cardiac patient who underwent cardiopulmonary bypass: A new era of Cardiac Regional Anesthesia. J Clin Anesth. 2018 Aug;48:9-10. doi: 10.1016/j.jclinane.2018.04.005. Epub 2018 May 26. No abstract available.

    PMID: 29684728BACKGROUND

  • Biswas A, Luginbuehl I, Szabo E, Caldeira-Kulbakas M, Crawford MW, Everett T. Use of Serratus Plane Block for Repair of Coarctation of Aorta: A Report of 3 Cases. Reg Anesth Pain Med. 2018 Aug;43(6):641-643. doi: 10.1097/AAP.0000000000000801.

    PMID: 29794944BACKGROUND

Study Officials

  • sebastien bertin, md

    VinMec HS

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Solution infused prepared by a different team with a rescue envelop to open in case of incident
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled double blind
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 3, 2019

Study Start

January 5, 2019

Primary Completion

August 14, 2023

Study Completion

August 14, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)