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

  • China
    • 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:

  1. Aged 18 to 80 years.
  2. ASA 1-3.
  3. Clinical diagnosis of gastric carcinoma and colorectal cancer without metastasis.
  4. Surgery for gastrointestinal surgery.

Exclusion Criteria:

  1. Patients and their family members refuse to accept the clinical trial;
  2. Complicated with acute cholangitis, gastrointestinal bleeding or ascites, etc.;
  3. Hepatic encephalopathy, psychosis or neuropathy;
  4. 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.
  5. 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
Other: Group Abdominal Nerve Block with local anesthetics
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.
Other: Group Abdominal Nerve Block with 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

Yi Liu

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

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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