ESP Block vs. Traditional Pain Management for ERAS

Phase 3

• Conditions: Postoperative Pain
• Interventions: Procedure: Erector spinae plane block

• Registration Number: NCT04299035
• Lead Sponsor: Soroka University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-05
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Last Update Submitted: 2020-03-05
• Study First Posted: 2020-03-06
• Last Update Posted: 2020-03-06
• Primary Completion: 2021-03-05
• Study Completion: 2021-09-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic surgery + ESPblock	Erector spinae plane block	Thoracic surgery + ESPblock + standard pain management
Abdominal surgery + ESPblock	Erector spinae plane block	Abdominal surgery + ESPblock + standard pain management
Spinal surgery + ESPblock	Erector spinae plane block	Spinal surgery + ESPblock + standard pain management

Primary Outcome Measures

Name	Time	Method
Visual Analog Pain Score	3 days	Reported immediate postoperative VAS score, up to 3rd day
Total pain med consumption in the PACU	3 hours	Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU
Length of stay in the PACU	24 hours	Length of stay in postoperative care room

Secondary Outcome Measures

Name	Time	Method
Chronic pain development	6 months	Rate of chronic pain at 3 and 6 months after surgery
Length of hospital stay	30 days	Length of hospital stay

Trial Locations

Locations (1)

SorokaUMC; 🇮🇱 Beersheba, Israel