Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03847363
Other study ID # cpsp-revisited
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date July 30, 2020

Study information

Verified date February 2019
Source Shanghai Zhongshan Hospital
Contact shuwei wang
Phone +8613564440601
Email veronciawang228@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study would compare acute and chronic postsurgical pain in patients underwent thoracic surgery with different anesthesia and analgesia methods, and explore the influencing factors.


Description:

Chronic postsurgical pain (CPSP) was the pain caused by the operation that exceeded the healing time of normal tissue (usually 3 months), that was, a status that the damage caused by noxious stimulus had been healed, but the pain that cannot be explained by disease and inflammation were still existed. Due to the location of the incision and the necessity of indwelling the chest tube, the thoracic lung surgery was considered to be one of the most painful surgical operations. Studies have found that the incidences of CPSP in patients with thoracotomy were 57% (95% CI, 51-64%) and 47% (95% CI, 39-56%) at postoperative 3 and 6 months, respectively. With the development of minimally invasive techniques, thoracic surgery had gradually become less traumatic, and the number of surgical incisions was gradually developed into single port.Through ages, epidural analgesia with a combination of local anesthetics and opioids had long been considered the "gold standard" for postoperative analgesia in thoracic surgery. However, with the development of clinical anesthetics and the widespread use of nerve block techniques, it had been found that in open radical gastrectomy, there was no significant difference in the inhibition of intraoperative stress response between dexmedetomidine combined with general anesthesia and a combined general-epidural anesthesia. So, which anesthesia and analgesia method was "perfect" for a specific type of surgery procedure? This study would compare acute and chronic postsurgical pain in patients underwent different thoracic surgery procedure with different anesthesia and analgesia methods, and explore the influencing factors.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date July 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- ASA I-II

- underwent selective thoracic surgery

Exclusion Criteria:

- with severe cardiac, endocrine,immunologic or haematologic diseases

- medical history of chronic pain problems in chest area

- medical history of pain-relief or sedative medication

- not able to communicate with investigators

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
epidural anesthesia
epidural anesthesia
nerve block
paravertebral or serratus anterior plane block

Locations

Country Name City State
China Zhongshan Hospital, Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary numerical rating scale of acute postsurgical pain numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain. at day1 post-operation
Primary numerical rating scale of acute postsurgical pain numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain. at day2 post-operation
Primary numerical rating scale of chronic postsurgical pain numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain. at 3rd month post-operation
Primary numerical rating scale of chronic postsurgical pain numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain. at 6th month post-operation
See also
  Status Clinical Trial Phase
Completed NCT04484610 - Appropriate Opioid Quantities for Acute Pain - Pharmacist Study Phase 4
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT03825549 - A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing N/A
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Recruiting NCT05589246 - Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure N/A
Recruiting NCT05572190 - Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects Phase 1
Terminated NCT04716413 - Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Phase 4
Active, not recruiting NCT03537573 - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care N/A
Not yet recruiting NCT06317844 - Examination of Psychological and Physiological Pathways Linking Gratitude and Pain N/A
Withdrawn NCT02957097 - Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures Phase 4
Completed NCT02565342 - Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery Phase 4
Terminated NCT02599870 - Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures N/A
Completed NCT02380989 - Integrative Ayurveda Healing Relieves Minor Sports Injury Pain Phase 2
Completed NCT02984098 - 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose Phase 4
Completed NCT02489630 - Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department Phase 4
Completed NCT03107338 - Preventive Treatment of Pain After Dental Implant Surgery Phase 4
Completed NCT02817477 - Intranasal Ketamine for Acute Traumatic Pain Phase 4