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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04306159
Other study ID # 201911
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2020
Est. completion date August 16, 2021

Study information

Verified date March 2020
Source The First Affiliated Hospital of Anhui Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

General anesthesia combined subcostal transversus abdominis plane (TAP)or rectus sheath block (RSB)can significantly reduce the use of opiates in minimally invasive surgery.However, similar reduction was not observed in open abdominal surgery during perioperative period.Therefore, the investigators should try to improve the blocking methods to reduce the side effects of a large number of opiates. Based on the range and its analgesic effect of various nerve block is obviously related to the injection site of local anesthetics, this randomized controlled study hypothesized that modified RSB under the guidance of surgical incision may be more effective in inhibiting the harmful stimulation of surgery.


Description:

For abdominal cancer surgery with midline incision, subcostal transversus abdominis plane or rectus sheath block combined with general anesthesia was more effective in reducing pain scores and opioid consumption compared with general anesthesia alone. However, there was no statistically significant difference in supplementary fentanyl during operation. Besides adequate pain relief around incisions, blunting visceral traction response has also an important role in hemodynamic stability.With the evidences for a potential mechanism for the antinociceptive effects of propofol on visceral nociception and dexmedetomidine combined with oxycodone can provide good visceral analgesia, the investigators supposed that visceral nociception was well suppressed by adequate antinociceptive drugs. The propofol combination with dexmedetomidine may had significant effect on the reduction of the sympathoadrenergic tone with decrease of blood pressure and heart rate.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date August 16, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Aged 18-85 years - Anesthesiologists (ASA) risk classification I to IV - Scheduled to undergo midline incision of upper abdomen (From xiphoid to navel ) Exclusion Criteria: - Patient refusal - Any contraindications to regional techniques (allergy to local anesthetics, infection around the site of the block, and coagulation disorder) - History of analgesics dependence - Any difficulty with communication - Allergy to the study drugs - Heat rate < 50 beats/minutes or II-III Atrioventricular block - Previous open surgery - Previous definite history of malignant tumor - Who had an estimated intraoperative blood loss of more than 500 mL

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Subcostal TAP
Subcostal transversus abdominis plane block
Modified RSB
Rectus Sheath Block under the guidance of surgical incision
Other:
General anesthesia
Traditional general anesthesia management

Locations

Country Name City State
China The First Affiliated Hospital of Anhui Medical University Hefei Anhui

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opiate consumption Remifentanil consumption From the beginning to the end of anesthesia,up to 6 hours.
Primary Tumor recurrence rate Tumor recurrence rate after surgery 1-year after surgery
Secondary Opiate consumption Sufentanil consumption From the end of anesthesia to 48 hours after surgery, up to 2 days.
Secondary Pain scores Through visual analogue scale (from 0 to 10) to assess the degree of pain;
The number 0 means no pain and the number 10 means the most pain;
Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.
2 hours after surgery
Secondary Pain scores Through visual analogue scale (from 0 to 10) to assess the degree of pain;
The number 0 means no pain and the number 10 means the most pain;
Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.
6 hours after surgery
Secondary Pain scores Through visual analogue scale (from 0 to 10) to assess the degree of pain;
The number 0 means no pain and the number 10 means the most pain;
Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.
12 hours after surgery
Secondary Pain scores Through visual analogue scale (from 0 to 10) to assess the degree of pain;
The number 0 means no pain and the number 10 means the most pain;
Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.
24 hours after surgery
Secondary Pain scores Through visual analogue scale (from 0 to 10) to assess the degree of pain;
The number 0 means no pain and the number 10 means the most pain;
Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.
36 hours after surgery
Secondary Pain scores Through visual analogue scale (from 0 to 10) to assess the degree of pain;
The number 0 means no pain and the number 10 means the most pain;
Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.
48 hours after surgery
Secondary Time for first to press pump Time for first to press pump Up to 2 days after surgery
Secondary Time of anal exsufflation Time for first anal exsufflation Up to 7 days after surgery
Secondary Delirium Incidence of postoperative delirium Up to 7 days after surgery
Secondary The occurrence of nausea and vomiting Incidence of nausea and vomiting Up to 7 days after surgery
Secondary The occurrence of cardiovascular or cerebrovascular events Incidence of cardiovascular or cerebrovascular adverse events From the end of surgery to the time the patients discharge, up to 1 month.
Secondary Length of hospital stay Length of hospital stay From the end of surgery to the time the patients discharge, up to 1 month.
Secondary Mortality Mortality after surgery 30-day after surgery
Secondary Mortality Mortality after surgery 1-year after surgery
Secondary Concentration of norepinephrine Concentration of norepinephrine during surgery Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
Secondary Concentration of epinephrine Concentration of epinephrine during surgery Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
Secondary Concentration of cortisol Concentration of cortisol during surgery Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
Secondary Concentration of tumor necrosis factor-a Concentration of tumor necrosis factor-a during surgery Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
Secondary Concentration of interleukin-6 Concentration of interleukin-6 during surgery Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
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