- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04147481
Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery
November 9, 2019 updated by: Yi Liu
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haidian
-
Beijing, Haidian, China, 100853
- Chinese PLA General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group Abdominal Nerve Block
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 0.2% ropivacaine
|
Placebo Comparator: Group control
surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.9% saline.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of postoperative chronic pain
Time Frame: 6 month after operation
|
The incidence of chronic pain 6 month after operation
|
6 month after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bedridden time
Time Frame: The postoperative duration up to 15 days
|
Postoperative bedridden time
|
The postoperative duration up to 15 days
|
Fasting time
Time Frame: The postoperative duration up to 15 days
|
Postoperative fasting time
|
The postoperative duration up to 15 days
|
Gastrointestinal decompression
Time Frame: The postoperative duration up to 15 days
|
Time of gastrointestinal decompression
|
The postoperative duration up to 15 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The numeric rating scale of postoperative pain
Time Frame: Within 7 days after surgery
|
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.
|
Within 7 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yi Liu, MD, the Chinese PLA General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 21, 2019
Primary Completion (Anticipated)
October 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
October 19, 2019
First Submitted That Met QC Criteria
October 30, 2019
First Posted (Actual)
November 1, 2019
Study Record Updates
Last Update Posted (Actual)
November 13, 2019
Last Update Submitted That Met QC Criteria
November 9, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Stomach Neoplasms
- Rectal Neoplasms
- Colonic Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
Other Study ID Numbers
- PLAGHAOC1901
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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