Analgesia After Video-Assisted Thoracic Surgery

February 18, 2022 updated by: Seham Mohamed Moeen Ibrahim, Assiut University

Analgesic Efficacy of Ultrasound-Guided Deep Serratus Anterior Plane Block, Local Wound Infiltration, and Thoracic Paravertebral Block After Uniportal Video-Assisted Thoracic Surgery: A Randomized Trial

Although less invasive, postoperative analgesia remains challenging in patients undergoing uniportal video-assisted thoracic surgery (VATS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Although less invasive, postoperative analgesia remains challenging in patients undergoing uniportal video-assisted thoracic surgery (VATS).

Adequate postoperative pain relief is imperative to hasten functional recovery, accelerate discharge from the hospital, and reduce chronic postsurgical pain.

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 2

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 Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Recruiting
        • Seham M. Moeen

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for uniportal VATS under general anesthesia, ASA status I-III, aged from 18 to 70 years old of both sex.

Exclusion Criteria:

  • Contraindications to regional block
  • Pregnancy
  • Body mass index (BMI) > 30 Kg/m2
  • Psychiatric diseases
  • Severe renal, liver, or cardiac dysfunction

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
Patients will receive ultrasound-guided deep serratus anterior plane block.
Drug: Ultrasound-guided deep serratus anterior plane block with isobaric bupivacaine
Patients will receive ultrasound-guided deep serratus anterior plane block with isobaric bupivacaine.
Active Comparator: Group II
Patients will receive local wound infiltration (LWI).
Drug: Local wound infiltration with isobaric bupivacaine
Patients will receive local wound infiltration with isobaric bupivacaine.
Placebo Comparator: Group III
Patients will receive ultrasound-guided thoracic paravertebral block.
Drug: Ultrasound-guided thoracic paravertebral block with isobaric bupivacaine
Patients will receive ultrasound-guided thoracic paravertebral block with isobaric bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic requirement
Time Frame: 24 hours after surgery
Assessed in minutes
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity
Time Frame: 24 hours after surgery
Assessed by the numerical rating pain scale, an 11-point scale graded from 0 to 10 (0 = no pain, 10 = the worst imaginable pain)
24 hours after surgery

Collaborators and Investigators

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

Sponsor

Assiut University

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)

February 18, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10 2021

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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