search
Back to results

Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

Primary Purpose

Esophageal Cancer, Perioperative Analgesia, NSAIDs

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Preemptive flurbiprofen axetil
Postoperative flurbiprofen axetil
Patient-controlled analgesia pump
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Postoperative NSAIDs

Preemptive analgesia followed by Postoperative NSAIDs

Postoperative patient-controlled analgesia pump

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Time to first postoperative flatus
Time from the end of surgery to the first flatus.
Time to first postoperative defaecation
Time from the end of surgery to the first defaecation.
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.
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.
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.
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).
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).
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 to first postoperative ambulation
Time from the end of surgery to the first postoperative ambulation
Hospital duration from operation to discharge
Time from the end of surgery to discharge from the hospital
Rate of pulmonary infection
Rate of pulmonary infection up to 30 days after surgery

Full Information

First Posted
July 18, 2022
Last Updated
August 15, 2022
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05504265
Brief Title
Perioperative Analgesia Modes in Minimally Invasive Esophagectomy
Official Title
Comparison of Efficacy and Safety of Different Analgesic Modes in Minimally Invasive Esophagectomy for Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2022 (Anticipated)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
May 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Perioperative Analgesia, NSAIDs, Opioid, Patient-controlled Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postoperative NSAIDs
Arm Type
Other
Arm Title
Preemptive analgesia followed by Postoperative NSAIDs
Arm Type
Experimental
Arm Title
Postoperative patient-controlled analgesia pump
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Preemptive flurbiprofen axetil
Intervention Description
50mg once，30min before induction anesthesia
Intervention Type
Drug
Intervention Name(s)
Postoperative flurbiprofen axetil
Intervention Description
50mg bid
Intervention Type
Device
Intervention Name(s)
Patient-controlled analgesia pump
Intervention Description
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 Outcome Measure Information:
Title
Postoperative pain score
Description
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
Title
Postoperative pain score
Description
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
Title
Postoperative pain score
Description
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
Title
Postoperative pain score
Description
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
Title
Postoperative pain score
Description
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
Title
Postoperative pain score
Description
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
Title
Postoperative pain score
Description
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
72 hours after surgery
Secondary Outcome Measure Information:
Title
Time to first postoperative flatus
Description
Time from the end of surgery to the first flatus.
Time Frame
Up to 14 days after surgery
Title
Time to first postoperative defaecation
Description
Time from the end of surgery to the first defaecation.
Time Frame
Up to 14 days after surgery
Title
Abdominal distension score
Description
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
Title
Abdominal distension score
Description
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
Title
Abdominal distension score
Description
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
Title
Side effects related to opioids
Description
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
Title
Side effects related to opioids
Description
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
Title
Side effects related to opioids
Description
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
Title
Time to first postoperative ambulation
Description
Time from the end of surgery to the first postoperative ambulation
Time Frame
Up to 14 days after surgery
Title
Hospital duration from operation to discharge
Description
Time from the end of surgery to discharge from the hospital
Time Frame
Up to 60 days after surgery
Title
Rate of pulmonary infection
Description
Rate of pulmonary infection up to 30 days after surgery
Time Frame
Up to 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhu zhixiang
Phone
13311131231
Email
zhuzhixiang2010@163.com
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

We'll reach out to this number within 24 hrs