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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intercostal nerve block
Sponsored by
Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ropivacaine combined with mecobalamine

ropivacaine

Arm Description

Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).

Intercostal nerve block with 0.5% ropivacaine alone.

Outcomes

Primary Outcome Measures

Incidence of chronic pain after chest surgery
The 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 Outcome Measures

The incidence of acute pain after chest surgery
An 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".
Incidence of postoperative neuropathic pain
The 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 complications
Postoperative 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 surgery
The incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up.
Incidence of death within 30 days after surgery
The incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up
Length of stay
The total length of hospital stay.
Cost of stay
The total cost of hospital stay.
icu length of stay
The number of hours of postoperative stay in ICU.
Incidence of secondary operation
Whether the patient has a second operation and the reason and the incidence of this operation.

Full Information

First Posted
November 30, 2019
Last Updated
January 1, 2020
Sponsor
Xuzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04217213
Brief Title
Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery
Official Title
Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ropivacaine combined with mecobalamine
Arm Type
Experimental
Arm Description
Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).
Arm Title
ropivacaine
Arm Type
Active Comparator
Arm Description
Intercostal nerve block with 0.5% ropivacaine alone.
Intervention Type
Procedure
Intervention Name(s)
Intercostal nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of chronic pain after chest surgery
Description
The 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".
Time Frame
At the 3rd month after surgery
Secondary Outcome Measure Information:
Title
The incidence of acute pain after chest surgery
Description
An 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".
Time Frame
24 to 72 hours after surgery
Title
Incidence of postoperative neuropathic pain
Description
The 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".
Time Frame
At the 3rd month after surgery
Title
Incidence of other postoperative complications
Description
Postoperative 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.
Time Frame
At the 3rd month after surgery
Title
Incidence of readmission within 30 days after surgery
Description
The incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up.
Time Frame
At the 30 days after surgery
Title
Incidence of death within 30 days after surgery
Description
The incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up
Time Frame
At the 30 days after surgery
Title
Length of stay
Description
The total length of hospital stay.
Time Frame
At the 3rd month after surgery
Title
Cost of stay
Description
The total cost of hospital stay.
Time Frame
At the 3rd month after surgery
Title
icu length of stay
Description
The number of hours of postoperative stay in ICU.
Time Frame
At the 3rd month after surgery
Title
Incidence of secondary operation
Description
Whether the patient has a second operation and the reason and the incidence of this operation.
Time Frame
At the 3rd month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old, conscious; ASA class Ⅰ ~ Ⅲ; Thoracoscopic lobectomy was proposed; The han nationality; Native speaker of Chinese; Agree to participate in this study and sign the informed consent. Exclusion Criteria: Patients allergic to meccobalamin or ropivacaine; Patients with previous history of chest surgery; Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture; Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease; Diabetic patients; Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.
Facility Information:
Facility Name
Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China

12. IPD Sharing Statement

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

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