Block and Erector Comparative Study Between Costotransverse Spinae Plane Block in Patients Undergoing Thoracotomy

March 3, 2024 updated by: Ahmed Mokhtar Ahmed, Sohag University

Block and Erector Comparative Study Between Costotransverse Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Thoracotomy

A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complications

Though epidural analgesia was once considered as the gold standard for post-thoracotomy pain management, it is not recommended for pain control after thoracotomy surgery because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma and hypotension(4). Thoracic paravertebral block (TPVB) and intercostal nerve block are well described and recognized techniques for postoperative analgesia following thoracic surgeries, such as thoracotomy and mastectomy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Contact Backup

  • Name: wesam A Abo Elwafa Sallam, Assistant professor
  • Phone Number: 01120623333

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:

  • • Age from 18 to 75 years old.

    • Both sexes.
    • American Society of Anesthesiologists (ASA) physical status I-II-III.
    • Patient undergoing unilateral thoracotomy surgery.

Exclusion Criteria:

  • • BMI more than 30 kg/m2.

    • Patients who are taking analgesics for chronic illness or have a history of substance abuse.
    • Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).
    • Patients with a history of coagulopathy.
    • Severe heart diseases.
    • Hepatic or renal insufficiency.
    • Infection at the site of infiltration

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: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group CTB
n=30): patients included in this group will receive unilateral US-guided CTB after general anesthesia. The CTB will be performed by using 20 ml bupivacaine 0.25%
Drug: Bupivacaine 0.25% Injectable Solution
Group CTB (n=30): patients included in this group will receive unilateral US-guided CTB after general anesthesia. The CTB will be performed by using 20 ml bupivacaine 0.25% Group ESPB (n=30): patients included in this group will receive unilateral US-guided ESPB after general anesthesia. The ESB will be performed by using 20 ml bupivacaine 0.25%
Active Comparator: Group ESPB
patients included in this group will receive unilateral US-guided ESPB after general anesthesia. The ESB will be performed by using 20 ml bupivacaine 0.25%
Drug: Bupivacaine 0.25% Injectable Solution
Group CTB (n=30): patients included in this group will receive unilateral US-guided CTB after general anesthesia. The CTB will be performed by using 20 ml bupivacaine 0.25% Group ESPB (n=30): patients included in this group will receive unilateral US-guided ESPB after general anesthesia. The ESB will be performed by using 20 ml bupivacaine 0.25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomy.
Time Frame: 5months
study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomyA standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. If visual analogue scale (VAS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia If visual analogue scale (VAS) is more than 5
5months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome is the total postoperative morphine consumption, time of first analgesic,
Time Frame: 5months
The secondary outcome is the total postoperative morphine consumption, time of first analgesic A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. If visual analogue scale (VAS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia If visual analogue scale (VAS) is more than 5
5months

Collaborators and Investigators

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

Sponsor

Sohag 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

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)

March 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

March 3, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-01-11MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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