ESP Block vs. Traditional Pain Management for ERAS

Soroka University Medical Center

Status and phase: Unknown; Phase 3

Conditions: Postoperative Pain

Treatments: Procedure: Erector spinae plane block

Study type: Interventional

Funder types: Other

Identifiers

NCT04299035

0355-19-SOR

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 6 patient groups

Thoracic surgery + ESPblock

Experimental group

Description:

Thoracic surgery + ESPblock + standard pain management

Treatment:

Procedure: Erector spinae plane block

Abdominal surgery + ESPblock

Experimental group

Description:

Abdominal surgery + ESPblock + standard pain management

Treatment:

Procedure: Erector spinae plane block

Spinal surgery + ESPblock

Experimental group

Description:

Spinal surgery + ESPblock + standard pain management

Treatment:

Procedure: Erector spinae plane block

Thoracic surgery

No Intervention group

Description:

Thoracic surgery + standard pain management

Abdominal surgery

No Intervention group

Description:

Abdominal surgery + standard pain management

Spinal surgery

No Intervention group

Description:

Spinal surgery + standard pain management