Thoracic Paravertebral Block for Postoperative Pain Management After VATS

November 13, 2024 updated by: King Hussein Cancer Center

Thoracic Paravertebral Block for Postoperative Pain Management in PACU After VATS Surgeries: A Randomized Controlled Trial

This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS). Adult patients scheduled for elective VATS who meet the eligibility criteria will be randomized to either Arm:

Arm 1: General anesthesia with TPVB;

Arm 2: General anesthesia alone (control group).

Primary Outcome: to assess Opioid requirement in the PACU

Study Type

Interventional

Enrollment (Actual)

81

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 Locations

  • Jordan
      • Amman, Jordan, 11941
        • King Hussein Cancer Center

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 scheduled for elective VATS, ASA physical status II-III, BMI 19-40.

Exclusion Criteria:

  • Patient refusal, coagulation disorders, contraindications to TPVB, chronic analgesic use, mental illness

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: General anesthesia with TPVB
0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space
Drug: 0.4 ml/kg of 0.5% bupivacaine
0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space
No Intervention: General anesthesia alone (control group).
General anesthesia SOC alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid requirement in the PACU
Time Frame: Opioid requirement assessed at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)
Opioid requirement in the PACU, recorded as "yes" or "no."
Opioid requirement assessed at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity measured by Numeric Rating Scale -NRS
Time Frame: Pain intensity measured using the Numeric Rating Scale (NRS) at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)
Pain intensity measured by Numeric Rating Scale- NRS at several time points, Range: 0 (no pain) to 10 (worst imaginable pain), Interpretation: Higher scores indicate worse pain intensity
Pain intensity measured using the Numeric Rating Scale (NRS) at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)

Collaborators and Investigators

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

Sponsor

King Hussein Cancer Center

Investigators

  • Principal Investigator: Ahed Al-Edwan, MD, KHCC

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 (Actual)

November 1, 2022

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22 KHCC 158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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