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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04299035
Other study ID # 0355-19-SOR
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 5, 2020
Est. completion date September 5, 2021

Study information

Verified date March 2020
Source Soroka University Medical Center
Contact Dmitry Natanel, MD
Phone +972533360451
Email nataneld@bgu.ac.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients undergoing thoracotomy, thoracoscopy or other surgical procedures involving the integrity of the chest wall are always in a special point of interest of both surgical and anesthesiological specialities. Most of the patients will describe the pain after thoracic surgery as severe. It might lead to a number of serious complications: respiratory failure due to splinting; inability to clear secretions by effective coughing, with resulting pneumonia; and turning into a chronic pain: the post-thoracotomy pain syndrome.

Traditional pain management in these groups of patients — such as opiate treatment, thoracic epidural analgesia, and non-opioid drugs — may have serious side effects. Large doses of opiates suppress the cough reflex and lead to respiratory depression with subsequent re-intubation and re-ventilation. Thoracic epidural analgesia, though being considered paramount among other analgesic options, requires a significant clinical experience. Still, it might be insufficient for satisfactory pain control and even complicated with pneumothorax, total spinal anaesthesia and inadvertent intravascular injection. Non-steroidal anti-inflammatory drugs (NSAIDs) and Tramadol are weak analgesics inadequate for severe pain control and might be responsible for gastrointestinal bleeding.

We suggest performing erector spinae plane block for intraoperative and postoperative pain management due to the ease of use and better analgesic effect. What remains is hard proof for the clinical efficacy and safety of this block, followed by a demonstration of the uptake of it in the hands of non-regional anaesthetists.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 5, 2021
Est. primary completion date March 5, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- all consecutive adult patients who undergo thoracic, spinal or abdominal surgery in Soroka Medical Center, and agree to participate in the study, older than 18 years, who meet criteria of ASA physical status I-II-III-IV class.

Exclusion Criteria:

- Unconscious or mentally incompetent patients or those who refuse to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Erector spinae plane block
Erector spinae plane block

Locations

Country Name City State
Israel SorokaUMC Beersheba

Sponsors (1)

Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Pain Score Reported immediate postoperative VAS score, up to 3rd day 3 days
Primary Total pain med consumption in the PACU Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU 3 hours
Primary Length of stay in the PACU Length of stay in postoperative care room 24 hours
Secondary Length of hospital stay Length of hospital stay 30 days
Secondary Chronic pain development Rate of chronic pain at 3 and 6 months after surgery 6 months
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