Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2019
CompletedStudy Start
First participant enrolled
October 21, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedNovember 13, 2019
November 1, 2019
1 year
October 19, 2019
November 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative chronic pain
The incidence of chronic pain 6 month after operation
6 month after operation
Secondary Outcomes (3)
Bedridden time
The postoperative duration up to 15 days
Fasting time
The postoperative duration up to 15 days
Gastrointestinal decompression
The postoperative duration up to 15 days
Other Outcomes (1)
The numeric rating scale of postoperative pain
Within 7 days after surgery
Study Arms (2)
Group Abdominal Nerve Block
EXPERIMENTALsurgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.2% ropivacaine
Group control
PLACEBO COMPARATORsurgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.9% saline.
Interventions
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 not 0.2% ropivacaine but 0.9% saline.
Eligibility Criteria
You may qualify if:
- Aged 18 to 80 years.
- ASA 1-3.
- Clinical diagnosis of gastric carcinoma and colorectal cancer without metastasis.
- Surgery for gastrointestinal surgery.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yi Liulead
Study Sites (1)
Chinese PLA General Hospital
Beijing, Haidian, 100853, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yi Liu, MD
the Chinese PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending doctor
Study Record Dates
First Submitted
October 19, 2019
First Posted
November 1, 2019
Study Start
October 21, 2019
Primary Completion
October 31, 2020
Study Completion
December 31, 2020
Last Updated
November 13, 2019
Record last verified: 2019-11