NCT05504265 - Perioperative Analgesia Modes in Minimally Invasive Esophagectomy | Crick | Crick

Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

Phase 3RecruitingNCT05504265

Cancer Institute and Hospital, Chinese Academy of Medical Sciences102 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Esophageal Cancer Perioperative Analgesia NSAIDs Opioid Patient-controlled Analgesia

Interventions

Preemptive flurbiprofen axetilDRUG

50mg once，30min before induction anesthesia

Postoperative flurbiprofen axetilDRUG

50mg bid

Patient-controlled analgesia pumpDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Postoperative pain score

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.

Time frame: 4 hours after surgery

Postoperative pain score

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.

Time frame: 12 hours after surgery

Postoperative pain score

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.

Time frame: 24 hours after surgery

Postoperative pain score

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.

Time frame: 36 hours after surgery

Postoperative pain score

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.

Time frame: 48 hours after surgery

Postoperative pain score

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.

Time frame: 60 hours after surgery

Postoperative pain score

Central Contacts

zhu zhixiang

CONTACT

13311131231 zhuzhixiang2010@163.com

Data from ClinicalTrials.gov

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Secondary Outcomes

Time to first postoperative flatus

Time from the end of surgery to the first flatus.

Time frame: Up to 14 days after surgery

Time to first postoperative defaecation

Time from the end of surgery to the first defaecation.

Time frame: Up to 14 days after surgery

Abdominal distension score

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.

Time frame: 24 hours after surgery

Abdominal distension score

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.

Time frame: 48 hours after surgery

Abdominal distension score

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.

Time frame: 72 hours after surgery

Side effects related to opioids

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

Time frame: 24 hours after surgery

Side effects related to opioids

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

Time frame: 48 hours after surgery

Side effects related to opioids

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

Time frame: 72 hours after surgery

Time to first postoperative ambulation

Time from the end of surgery to the first postoperative ambulation

Time frame: Up to 14 days after surgery

Hospital duration from operation to discharge

Time from the end of surgery to discharge from the hospital

Time frame: Up to 60 days after surgery

Rate of pulmonary infection

Rate of pulmonary infection up to 30 days after surgery

Time frame: Up to 30 days after surgery