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

NCT05825378 | Unknown DMC

• 1 other identifier: 20230411
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Rebound Pain; Dexamethasone; Intercostal Nerve Block; Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of rebound pain after the disappearance of nerve block effect

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

  8 hours after the nerve block

Study Arms (2)

group dexamethasone

EXPERIMENTAL

Dexamethasone 8mg+0.375% ropivacaine

Drug: Dexamethasone 8mg+0.375% ropivacaine

group control

SHAM COMPARATOR

0.375% ropivacaine

Drug: 0.375% ropivacaine

Interventions

Dexamethasone 8mg+0.375% ropivacaine DRUG

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

group dexamethasone

0.375% ropivacaine DRUG

Ultrasound-guided intercostal nerve block was performed on the surgical side, and 3 to 5ml 0.375% ropivacaine was injected at each point

group control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

Location

MeSH Terms

Interventions

Dexamethasone; Ropivacaine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ruquan Han, M.D., PhD.

CONTACT

8610-59976660; ruquan.han@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: May 1, 2023
• Primary Completion: May 5, 2025
• Study Completion: August 6, 2025
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)