ESP Block vs. Traditional Pain Management for ERAS

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04299035
• Other study ID #: 0355-19-SOR
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

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