Dexmeditomedine as an Adjuvant to Levobupivacaine in Transversus Thoracis Plane Block on the Management of Post-sternotomy Pain in Open-heart Surgeries

May 9, 2024 updated by: Ahmed wahby Shamsedine, Assiut University
the study is to assess the efficacy of dexmeditomedine as an adjuvant to the local anaesthetic levobupivacaine in transversus thoracis plane block given bilaterally on the management of post-sternotomy pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

the patients will fall into one of two groups using an online randomizer. this study is an assessor-blinded interventional controlled study. the first group will recieve transversus thoracis plane block bilaterally where 15 ml of 0.25% levobupivacaine will be given. and the other group shall also undergo a bilateral transversus thoracis plane block with 15 ml 0.25% levobupivacaine and 0.05 ug/kg dexmeditomedine on each side. the primary aim of the study is the 24 hour post-operative morphine consumption.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients > 20 years old.
  • ASA II to III patients undergoing elective cardiac surgery via a median sternotomy

Exclusion Criteria:

  • Patient's refusal.
  • Known contraindications to regional blocks, including local skin infections,and coagulopathy.
  • Allergies to the local anaesthetics used.
  • Patients undergoing complex cardiac procedures.
  • Patients with severe chronic obstructive pulmonary disease.
  • Patients unable to communicate.
  • Patients with chronic pain.
  • Patients with severe pulmonary hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Levobupivacaine group
  • Patients in this group shall receive levobupivacaine alone.
  • Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25% will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
Procedure: transversus thoracis plane block
with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, different drugs according to the different groups will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
Other Names:
  • TTPB
Drug: Levobupivacaine
A local anesthetic that will be instilled in the transversus thoracic plane in a dose of 15 ml of a 25% concentration on both sides of the sternum in both groups
Active Comparator: Combined levobupivacaine, and dexmeditomedine group
  • Patients in this group shall receive levobupivaciane in addition to dexmeditomedine as an adjuvant.
  • Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25%, together with dexmeditomedine in a dose of 1 ug/kg will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
Procedure: transversus thoracis plane block
with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, different drugs according to the different groups will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
Other Names:
  • TTPB
Drug: Levobupivacaine
A local anesthetic that will be instilled in the transversus thoracic plane in a dose of 15 ml of a 25% concentration on both sides of the sternum in both groups
Drug: Dexmedetomidine
the dexmeditomedine group shall undergo bilateral transversus thoracis plane block with 15 ml of 25% levobupivacaine, and 0.05 ug/kg dexmeditomedine on each side of the sternum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total post-operative morphine consumption.
Time Frame: 24 hours post-operative
If the patient experiences a pain of > 4, he will be given morphine intravenously in a dose of 0.05 mg/kg IV by a blinded assessor, aiming for a pain score of ≤ 4. The total morphine dose for the post-operative 24 hours will be compared between the case and control group, to determine which technique provided more analgesia.
24 hours post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain score
Time Frame: 24 hours post-operative
VAS (Visual Analogue Scale, 0-10; where 0 = no pain, and 10 = worst imaginable pain) will be assessed at rest, preoperatively, half an hour after extubation, and at 4th, 8th, 12th, 16th, 20th, and 24th hours post operatively. Moreover, VAS will also be assessed at 12th and 24 hours post-operatively while coughing.
24 hours post-operative
Time till request of first analgesia.
Time Frame: 24 hours post-operative
comparison of the time till request of first analgesia difference between the two groups, shall give us a clue to the effect of demeditomedine on the duration of the pain controlling effect of the used block.
24 hours post-operative
Intensive Care Unit (ICU) stay length.
Time Frame: 4 days
time till discharge from the ICU
4 days
Complications of the interventional block
Time Frame: 24 hours post-operative
  • Pneumothorax.
  • Hemothorax.
  • Local anaesthetic systemic toxicity.
  • Intravascular injection.
  • Allergy to the local anaesthetic used.
  • Infection.
  • Hematoma.
  • Neural injury.
  • Damage to internal thoracic artery.
24 hours post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • post-sternotomy pain control

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

the decision shall be taken at the end of the study. I anticipate that it is going to be a "yes".

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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