Opioid Consumption Clinical Trial
Official title:
Application of Opioid-sparing Multimodal Anesthesia Based on Rectus Sheath Block in Open Upper Abdominal Surgery:A Randomized Controlled Study
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 |
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Anhui Medical University |
China,
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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