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NCT Number: NCT05504265

Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

This study was designed to compare analgesic efficacy and safety of different perioperative analgesic modes in minimally invasive esophagectomy for esophageal cancer.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms NSAIDs Neoplasms Neoplasms by Site Opioid Patient-Controlled Analgesia Perioperative Analgesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location status: Recruiting

Location contact

Yin Li, MD

CONTACT

[email protected]

861087788052

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-75 years;
  • Patients underwent laparoscopic and thoracoscopic or robotic-assisted minimally invasive esophagectomy ;
  • Informed consent.

Exclusion criteria

  • Has a history of cholecystitis or urolithiasis within 3 months;
  • Has a history of atherothrombosis (peripheral arterial disease), stroke, myocardial infarction;
  • With lung diseases, such as pneumonia, atelectasis, emphysema, pulmonary bullae, etc;
  • Preoperative cardiac function grade ≥ III or coronary artery stenosis;
  • Preoperative indwelling of a thoracic drainage tube;
  • Long-term heavy drinker(heavy drinking was defined as follows: for men, consuming more than 4 drinks on any day or more than 14 drinks per week; For women, consuming more than 3 drinks on any day or more than 7 drinks per week);
  • Opioid-tolerant patients(defined as those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid);
  • With painful skin complications, such as rashes and blisters;
  • Conversion to open surgery;
  • The postoperative ventilation function was limited, or the duration of endotracheal intubation was more than 24h.

Treatment and study plan

Preemptive flurbiprofen axetil

Drug

50mg once，30min before induction anesthesia

Postoperative flurbiprofen axetil

Drug

50mg bid

Patient-controlled analgesia pump

Device

Sufentanil 2.5 μg/kg+ondansetron 8mg, prepared to 100ml normal saline; background dose: 2 ml/h, single press analgesic pump injection volume: 0.5 ml, locking time: 15 min.

Primary outcomes

  1. Postoperative pain score

    Time frame: 4 hours after surgery

    In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.

  2. Postoperative pain score

    Time frame: 12 hours after surgery

    In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.

  3. Postoperative pain score

    Time frame: 24 hours after surgery

    In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.

  4. Postoperative pain score

    Time frame: 36 hours after surgery

    In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.

  5. Postoperative pain score

    Time frame: 48 hours after surgery

    In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.

  6. Postoperative pain score

    Time frame: 60 hours after surgery

    In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.

  7. Postoperative pain score

    Time frame: 72 hours after surgery

    In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.

Secondary outcomes

  1. Time to first postoperative flatus

    Time frame: Up to 14 days after surgery

    Time from the end of surgery to the first flatus.

  2. Time to first postoperative defaecation

    Time frame: Up to 14 days after surgery

    Time from the end of surgery to the first defaecation.

  3. Abdominal distension score

    Time frame: 24 hours after surgery

    Abdominal distension was measured using a scoring system, '0' is the minimum value that indicates no abdominal distension, while '10' is the maximum value that defines the most severe abdominal distension.

  4. Abdominal distension score

    Time frame: 48 hours after surgery

    Abdominal distension was measured using a scoring system, '0' is the minimum value that indicates no abdominal distension, while '10' is the maximum value that defines the most severe abdominal distension.

  5. Abdominal distension score

    Time frame: 72 hours after surgery

    Abdominal distension was measured using a scoring system, '0' is the minimum value that indicates no abdominal distension, while '10' is the maximum value that defines the most severe abdominal distension.

  6. Side effects related to opioids

    Time frame: 24 hours after surgery

    Nausea and vomiting were measured using a scoring system(0 = no nausea, 1 = only nausea, 2 = both nausea and vomiting).

  7. Side effects related to opioids

    Time frame: 48 hours after surgery

    Nausea and vomiting were measured using a scoring system(0 = no nausea, 1 = only nausea, 2 = both nausea and vomiting).

  8. Side effects related to opioids

    Time frame: 72 hours after surgery

    Nausea and vomiting were measured using a scoring system(0 = no nausea, 1 = only nausea, 2 = both nausea and vomiting).

  9. Time to first postoperative ambulation

    Time frame: Up to 14 days after surgery

    Time from the end of surgery to the first postoperative ambulation

  10. Hospital duration from operation to discharge

    Time frame: Up to 60 days after surgery

    Time from the end of surgery to discharge from the hospital

  11. Rate of pulmonary infection

    Time frame: Up to 30 days after surgery

    Rate of pulmonary infection up to 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

zhu zhixiang

CONTACT

[email protected]

13311131231

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Comparison of Efficacy and Safety of Different Analgesic Modes in Minimally Invasive Esophagectomy for Esophageal Cancer

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2022
Registry last updated
Mar 20, 2025

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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