Perioperative Analgesia Modes in Minimally Invasive Esophagectomy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
This study was designed to compare analgesic efficacy and safety of different perioperative analgesic modes in minimally invasive esophagectomy for esophageal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-75 years;
Patients underwent laparoscopic and thoracoscopic or robotic-assisted minimally invasive esophagectomy ;
Informed consent.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Preemptive flurbiprofen axetil
Drug50mg once，30min before induction anesthesia
Postoperative flurbiprofen axetil
Drug50mg bid
Patient-controlled analgesia pump
DeviceSufentanil 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.
Treatment groups
102 Participants
are divided into 3 treatment groupsGroup A: Postoperative NSAIDsOther 1 intervention
Group B: Preemptive analgesia followed by Postoperative NSAIDsExperimental treatment 2 interventions
Group C: Postoperative patient-controlled analgesia pumpExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 surgery2
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 surgery3
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 surgery4
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 surgerySecondary outcomes
1
Time to first postoperative flatus
Time from the end of surgery to the first flatus.
Time frame
Up to 14 days after surgery2
Time to first postoperative defaecation
Time from the end of surgery to the first defaecation.
Time frame
Up to 14 days after surgery3
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 surgery4
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 surgerySponsors and contacts
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Source ClinicalTrials.gov