A Phase 3 interventional study of Erector spinae plane block in Postoperative Pain, sponsored by Soroka University Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-06.
Sponsored by Soroka University Medical Center · Phase 3, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 300 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Soroka University Medical Center is the lead sponsor of 157 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Thoracic surgery + ESPblock + standard pain management
Procedure: Erector spinae plane block
Abdominal surgery + ESPblock + standard pain management
Procedure: Erector spinae plane block
Spinal surgery + ESPblock + standard pain management
Procedure: Erector spinae plane block
Thoracic surgery + standard pain management
Abdominal surgery + standard pain management
Spinal surgery + standard pain management
Erector spinae plane block
Visual Analog Pain Score
Reported immediate postoperative VAS score, up to 3rd day
Time frame: 3 days
Total pain med consumption in the PACU
Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU
Time frame: 3 hours
Length of stay in the PACU
Length of stay in postoperative care room
Time frame: 24 hours
Length of hospital stay
Length of hospital stay
Time frame: 30 days
Chronic pain development
Rate of chronic pain at 3 and 6 months after surgery
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Soroka University Medical Center