ESP Block vs. Traditional Pain Management for ERAS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-05

Study Completion Date

2021-09-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Thoracic surgery + ESPblock

Thoracic surgery + ESPblock + standard pain management

Group Type EXPERIMENTAL

Erector spinae plane block

Intervention Type PROCEDURE

Erector spinae plane block

Abdominal surgery + ESPblock

Abdominal surgery + ESPblock + standard pain management

Group Type EXPERIMENTAL

Erector spinae plane block

Intervention Type PROCEDURE

Erector spinae plane block

Spinal surgery + ESPblock

Spinal surgery + ESPblock + standard pain management

Group Type EXPERIMENTAL

Erector spinae plane block

Intervention Type PROCEDURE

Erector spinae plane block

Thoracic surgery

Thoracic surgery + standard pain management

Group Type NO_INTERVENTION

No interventions assigned to this group

Abdominal surgery

Abdominal surgery + standard pain management

Group Type NO_INTERVENTION

No interventions assigned to this group

Spinal surgery

Spinal surgery + standard pain management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erector spinae plane block

Intervention Type PROCEDURE

Eligibility Criteria

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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.