Back to resultsEffects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery
Primary Purpose
Colon Cancer, Rectal Cancer, Gastric Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Group Abdominal Nerve Block with local anesthetics
Group Abdominal Nerve Block with saline
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 80 years.
- ASA 1-3.
- Clinical diagnosis of gastric carcinoma and colorectal cancer without metastasis.
- Surgery for gastrointestinal surgery.
Exclusion Criteria:
- Patients and their family members refuse to accept the clinical trial;
- Complicated with acute cholangitis, gastrointestinal bleeding or ascites, etc.;
- Hepatic encephalopathy, psychosis or neuropathy;
- Body weight for acid-base and electrolyte imbalances, endotoxemia, and cachexia decreased by more than 2% or 5% in the past 2 months or 6 months.
- Uncontrolled hypertentsion, coronary heart disease, diabetes.
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group Abdominal Nerve Block
Group control
Arm Description
surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.2% ropivacaine
surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.9% saline.
Outcomes
Primary Outcome Measures
Incidence of postoperative chronic pain
The incidence of chronic pain 6 month after operation
Secondary Outcome Measures
Bedridden time
Postoperative bedridden time
Fasting time
Postoperative fasting time
Gastrointestinal decompression
Time of gastrointestinal decompression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04147481
Brief Title
Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery
Official Title
Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Liu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To explore the effect of general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) on the recovery of patients with gastrointestinal tumor after surgical treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer, Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Abdominal Nerve Block
Arm Type
Experimental
Arm Description
surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.2% ropivacaine
Arm Title
Group control
Arm Type
Placebo Comparator
Arm Description
surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.9% saline.
Intervention Type
Other
Intervention Name(s)
Group Abdominal Nerve Block with local anesthetics
Intervention Description
surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.2% ropivacaine
Intervention Type
Other
Intervention Name(s)
Group Abdominal Nerve Block with saline
Intervention Description
surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with not 0.2% ropivacaine but 0.9% saline.
Primary Outcome Measure Information:
Title
Incidence of postoperative chronic pain
Description
The incidence of chronic pain 6 month after operation
Time Frame
6 month after operation
Secondary Outcome Measure Information:
Title
Bedridden time
Description
Postoperative bedridden time
Time Frame
The postoperative duration up to 15 days
Title
Fasting time
Description
Postoperative fasting time
Time Frame
The postoperative duration up to 15 days
Title
Gastrointestinal decompression
Description
Time of gastrointestinal decompression
Time Frame
The postoperative duration up to 15 days
Other Pre-specified Outcome Measures:
Title
The numeric rating scale of postoperative pain
Description
The numerical rating scale (0-10) of posteoperaitve acute pain. If the NRS was larger than 4, we must take emergency action, including pressuring patient controlled analgesia pump, giving other analgesics.
Time Frame
Within 7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 to 80 years.
ASA 1-3.
Clinical diagnosis of gastric carcinoma and colorectal cancer without metastasis.
Surgery for gastrointestinal surgery.
Exclusion Criteria:
Patients and their family members refuse to accept the clinical trial;
Complicated with acute cholangitis, gastrointestinal bleeding or ascites, etc.;
Hepatic encephalopathy, psychosis or neuropathy;
Body weight for acid-base and electrolyte imbalances, endotoxemia, and cachexia decreased by more than 2% or 5% in the past 2 months or 6 months.
Uncontrolled hypertentsion, coronary heart disease, diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Liu, MD
Organizational Affiliation
the Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Haidian
ZIP/Postal Code
100853
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery
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