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

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05825378
Collaborator
(none)
260
Enrollment
1
Location
2
Arms
27.2
Anticipated Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone 8mg+0.375% ropivacaine
  • Drug: 0.375% ropivacaine
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Intercostal Nerve Block With Dexamethasone and Ropivacaine on Rebound Pain After Thoracoscopic Surgery: a Randomized, Double-blind, Controlled Study
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 5, 2025
Anticipated Study Completion Date :
Aug 6, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The incidence of rebound pain after the disappearance of nerve block effect [8 hours after the nerve block]

    NRS < 3 in PACU and NRS > 7 after the disappearance of nerve block effect

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tiantan Hospital, Capital Medical University Beijing China 100070

Sponsors and Collaborators

  • Beijing Tiantan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruquan Han, Director of Anesthesiology Department, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT05825378
Other Study ID Numbers:
  • 20230411
First Posted:
Apr 24, 2023
Last Update Posted:
Apr 24, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dexamethasone
Ropivacaine

Study Results

No Results Posted as of Apr 24, 2023