The Effect of Intercostal Nerve Block With Dexamethasone and Ropivacaine on Rebound Pain After Thoracoscopic Surgery

April 11, 2023 updated by: Ruquan Han, Beijing Tiantan Hospital

The Effect of Intercostal Nerve Block With Dexamethasone and Ropivacaine on Rebound Pain After Thoracoscopic Surgery: a Randomized, Double-blind, Controlled Study

Regional nerve block is one of the commonly used methods for postoperative analgesia after thoracoscopic surgery. Recent studies have found that rebound pain may occur after regional block, which is defined as acute postoperative pain that occurs after the resolution of sensory block related to regional anesthesia, and seriously affects the quality of postoperative recovery of patients. There is evidence that rebound tenderness is associated with local anesthetic toxicity and proinflammatory effects. The aim of this study was to investigate the effect of dexamethasone on rebound pain after a single intercostal nerve block in patients undergoing thoracoscopic surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

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 Locations

  • China
      • Beijing, China, 100070
        • Beijing Tiantan Hospital, Capital Medical University

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:

  • Patients scheduled for elective thoracoscopic surgery Age > 18 years old ASA ⅰ-ⅲ Informed consent was signed

Exclusion Criteria:

  • Patients with aoagulation disorders Patients with allergy to local anesthetics Patients with severe cardiopulmonary diseases Patients had systemic steroid use Patients with chronic pain Patients with uncontrolled diabetes and mental disorders History of drug abuse; Body Mass Index more than 35 kg.m-2 Pregnant or breastfeeding woman.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group dexamethasone
Dexamethasone 8mg+0.375% ropivacaine
Drug: Dexamethasone 8mg+0.375% ropivacaine
Ultrasound-guided intercostal nerve block was performed on the surgical side, and 3 to 5ml of a mixture of 0.375% ropivacaine and 8 mg dexamethasone was injected at each point
Sham Comparator: group control
0.375% ropivacaine
Drug: 0.375% ropivacaine
Ultrasound-guided intercostal nerve block was performed on the surgical side, and 3 to 5ml 0.375% ropivacaine was injected at each point

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of rebound pain after the disappearance of nerve block effect
Time Frame: 8 hours after the nerve block
NRS < 3 in PACU and NRS > 7 after the disappearance of nerve block effect
8 hours after the nerve block

Collaborators and Investigators

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

Sponsor

Beijing Tiantan Hospital

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 (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 5, 2025

Study Completion (Anticipated)

August 6, 2025

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230411

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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