Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery

NCT ID: NCT04912557

Last Updated: 2024-09-25

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

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-14

Study Completion Date

2021-12-11

Brief Summary

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Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.

Detailed Description

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Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.

Epidural analgesia does not guarantee total control of acute postoperative pain after major open abdominal surgery. The performance of epidural analgesia could vary according to predisposing factors and postoperative days. Inadequate epidural analgesia could be associated with greater morbidity after open major abdominal surgery.

In order to evaluate the performance of epidural analgesia after major open abdominal surgery, a prospective observational monocentric scheme seems relevant. The evaluation will be clinical based on questioning and a brief medical examination during the early postoperative phase of the operated patients.

Conditions

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Epidural Analgesia After Major Open Abdominal Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Open major abdominal surgery patient (predicted operative time ≥ 2 hours) with Peridural Analgesia accepted

postoperative pain assess

Intervention Type OTHER

numerical pain scale and Metameric levels of cold insensitivity

Interventions

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postoperative pain assess

numerical pain scale and Metameric levels of cold insensitivity

Intervention Type OTHER

Other Intervention Names

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numerical pain scale

Eligibility Criteria

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Inclusion Criteria

* Major abdominal surgery patient operated by laparotomy (predicted operative time ≥ 2 hours)
* epidural analgesia accepted

Exclusion Criteria

* Minor or protected patient
* Patients under guardianship, curatorship or safeguard of justice
* Pregnant or breastfeeding woman
* Contraindication or refusal of epidural analgesia
* Failure of the initial placement of the epidural catheter
* Major intraoperative complication requiring continued postoperative sedation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume PORTA-BONETE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2021-A00926-35

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/21/0160

Identifier Type: -

Identifier Source: org_study_id

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