Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery

Gastric Cancer Clinical Trial

Official title:

Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04147481
• Other study ID #: PLAGHAOC1901
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2019
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Gastric Cancer
• Rectal Cancer
• Rectal Neoplasms
• Stomach Neoplasms

Intervention

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
• 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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Haidian

Sponsors (1)

Lead Sponsor	Collaborator
Yi Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The numeric rating scale of postoperative pain	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
Primary	Incidence of postoperative chronic pain	The incidence of chronic pain 6 month after operation	6 month after operation
Secondary	Bedridden time	Postoperative bedridden time	The postoperative duration up to 15 days
Secondary	Fasting time	Postoperative fasting time	The postoperative duration up to 15 days
Secondary	Gastrointestinal decompression	Time of gastrointestinal decompression	The postoperative duration up to 15 days