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Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery

Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04217213
Enrollment
124
Registered
2020-01-03
Start date
2020-01-01
Completion date
2020-11-30
Last updated
2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

This project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (CPSP) in thoracic postoperative patients. Related clinical characteristics of postoperative chronic pain. The results of the study provide clinicians with a simple and inexpensive new method of preventing CPSP, in order to prevent the occurrence of CPSP and reduce the incidence of CPSP, thereby reducing CPSP to patients and their families, hospitals. And public resources.

Interventions

In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity. 5ml was injected into each intercostal nerve block.

Sponsors

Xuzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥18 years old, conscious; 2. ASA class Ⅰ \ Ⅲ; 3. Thoracoscopic lobectomy was proposed; 4. The han nationality; 5. Native speaker of Chinese; 6. Agree to participate in this study and sign the informed consent.

Exclusion criteria

1. Patients allergic to meccobalamin or ropivacaine; 2. Patients with previous history of chest surgery; 3. Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture; 4. Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease; 5. Diabetic patients; 6. Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of chronic pain after chest surgeryAt the 3rd month after surgeryThe incidence of chronic pain after chest surgery was measured by NRS(numeric rating scales) at the 3rd month after surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented no pain and a score of 10 represented worst pain imaginable.

Secondary

MeasureTime frameDescription
Incidence of postoperative neuropathic painAt the 3rd month after surgeryThe incidence of neuropathic pain was measured by DN4 scale at the 3rd month after surgery.Douleur Neuropathique 4 (DN4) is a screening questionnaire to help identify neuropathic pain (NP) in clinical practice and research,where a DN4 scores greater than or equal to 4 represented the patients had postoperative neuropathic pain.
Incidence of other postoperative complicationsAt the 3rd month after surgeryPostoperative complications included that pulmonary complications, delirium, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, incision infection, cerebrovascular accident and other complications related to surgery.
Incidence of readmission within 30 days after surgeryAt the 30 days after surgeryThe incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up.
Incidence of death within 30 days after surgeryAt the 30 days after surgeryThe incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up
The incidence of acute pain after chest surgery24 to 72 hours after surgeryAn NRS score was performed 24 to 72 hours after surgery to determine the incidence of acute pain after thoracic surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented no pain and a score of 10 represented worst pain imaginable.
Cost of stayAt the 3rd month after surgeryThe total cost of hospital stay.
icu length of stayAt the 3rd month after surgeryThe number of hours of postoperative stay in ICU.
Incidence of secondary operationAt the 3rd month after surgeryWhether the patient has a second operation and the reason and the incidence of this operation.
Length of stayAt the 3rd month after surgeryThe total length of hospital stay.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026