NCT05897307

Brief Summary

Background: Multimodal analgesia for control of postoperative pain in cardiac surgical patients helps in early recovery and ambulation. Pectoral nerve (PECS) block with ropivacaine is novel, less invasive regional analgesic technique with an effect comparable to paravertebral, and thoracic epidural analgesia. Aim: The aim of this study is to assess the effect of dexmedetomidine as an adjuvant to ropivacaine on the quality and efficiency of the ultra-sound guided pectoralis nerve block in patients undergoing open heart surgery through midline sternotomy for fast-track anesthesia and postoperative analgesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 23, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

May 23, 2023

Last Update Submit

September 11, 2023

Conditions

Post Operative Pain

Keywords

cardiac surgeryfast track anesthesiapostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • the total postoperative opioid consumption

    the total postoperative opioid consumption

    the first 48 hours postoperative

Secondary Outcomes (1)

  • Duration of mechanical ventilation

    the first 48 hours postoperative

Study Arms (3)

Group (C)

PLACEBO COMPARATOR

will not receive any regional anesthesia and only will receive fentanyl 1μg/kg/hr.

Drug: Ropivacaine

Group (R)

ACTIVE COMPARATOR

will receive 30 ml of 0.25% of plain ropivacaine for each side.

Drug: Ropivacaine

Group (DR)

ACTIVE COMPARATOR

will receive 30 ml of 0.25% of ropivacaine + dexmedetomidine 0.5 μg/kg for each side.

Drug: Ropivacaine

Interventions

RopivacaineDRUG

dexmedetomidine

Group (C)Group (DR)Group (R)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20 - 65 years,
  • Ejection fraction (EF) \> 35%,
  • Elective-isolated CABG, or Valve surgery

You may not qualify if:

  • Poor left ventricular function with intra-aortic balloon pump support,
  • Recent myocardial infarction (last seven days),
  • Combined procedure (i.e., CABG + other heart/vascular procedure),
  • Emergency surgery, or Redo cases,
  • Hepatic or renal failure, creatinine \>1.5,
  • Patients with hemodynamic instability, preexisting infection at the site of block, allergy to local anesthetics, psychiatric illness, and patients with prolonged postoperative ventilatory course were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, Saudi Arabia

RECRUITING

Related Publications (2)

  • Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

    PMID: 22939099BACKGROUND

  • Ueshima H, Otake H. RETRACTED: Ultrasound-guided pectoral nerves (PECS) block: Complications observed in 498 consecutive cases. J Clin Anesth. 2017 Nov;42:46. doi: 10.1016/j.jclinane.2017.08.006. Epub 2017 Aug 9. No abstract available.

    PMID: 28802149BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Mohamed Ahmed Hamed, MD

CONTACT

01010509736mah07@fayoum.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the head of anesthesia department

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 9, 2023

Study Start

August 1, 2023

Primary Completion

August 10, 2024

Study Completion

August 20, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

no plane

Locations

SA(1)