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Clinical Trials/NCT04299035
NCT04299035
Unknown
Phase 3

Erector Spinae Plane Block Versus Traditional Pain Management for Enhanced Recovery After Surgery

Soroka University Medical Center1 site in 1 country300 target enrollmentMarch 5, 2020

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Soroka University Medical Center
Enrollment
300
Locations
1
Primary Endpoint
Visual Analog Pain Score
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 5, 2020
End Date
September 5, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dmitry Natanel MD

Dr.

Soroka University Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Visual Analog Pain Score

Time Frame: 3 days

Reported immediate postoperative VAS score, up to 3rd day

Length of stay in the PACU

Time Frame: 24 hours

Length of stay in postoperative care room

Total pain med consumption in the PACU

Time Frame: 3 hours

Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU

Secondary Outcomes

  • Length of hospital stay(30 days)
  • Chronic pain development(6 months)

Study Sites (1)

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