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NCT Number: NCT04912557

Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Toulouse

Toulouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

postoperative pain assess

Other

numerical pain scale and Metameric levels of cold insensitivity

Other names: numerical pain scale

Primary outcomes

  1. Insufficient epidural analgesia

    Time frame: day 5

    Insufficient epidural analgesia will be defined by the presence of pain assessed by numerical scale > 3/10 at rest OR on coughing OR on mobilization.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: PAPCAM

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 3, 2021
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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