NCT04299035

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_3 postoperative-pain

Timeline
Completed

Started Mar 2020

Typical duration for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2021

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 5, 2020

Last Update Submit

March 5, 2020

Conditions

Postoperative Pain

Keywords

Postoperative painErector spinae plane block

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Pain Score

    Reported immediate postoperative VAS score, up to 3rd day

    3 days

  • Total pain med consumption in the PACU

    Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU

    3 hours

  • Length of stay in the PACU

    Length of stay in postoperative care room

    24 hours

Secondary Outcomes (2)

  • Length of hospital stay

    30 days

  • Chronic pain development

    6 months

Study Arms (6)

Thoracic surgery + ESPblock

EXPERIMENTAL

Thoracic surgery + ESPblock + standard pain management

Procedure: Erector spinae plane block

Abdominal surgery + ESPblock

EXPERIMENTAL

Abdominal surgery + ESPblock + standard pain management

Procedure: Erector spinae plane block

Spinal surgery + ESPblock

EXPERIMENTAL

Spinal surgery + ESPblock + standard pain management

Procedure: Erector spinae plane block

Thoracic surgery

NO INTERVENTION

Thoracic surgery + standard pain management

Abdominal surgery

NO INTERVENTION

Abdominal surgery + standard pain management

Spinal surgery

NO INTERVENTION

Spinal surgery + standard pain management

Interventions

Erector spinae plane blockPROCEDURE

Erector spinae plane block

Abdominal surgery + ESPblockSpinal surgery + ESPblockThoracic surgery + ESPblock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unconscious or mentally incompetent patients or those who refuse to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SorokaUMC

Beersheba, Israel

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Michael Dubilet, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry Natanel, MD

CONTACT

+972533360451nataneld@bgu.ac.il

Michael Dubilet, MD

CONTACT

michaeldu@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 6, 2020

Study Start

March 5, 2020

Primary Completion

March 5, 2021

Study Completion

September 5, 2021

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)