Clinical trial NCT04306159: Application of Rectus Sheath Block based-on Incision in Upper Abdominal Surgery
Official title: Application of Opioid-sparing Multimodal Anesthesia Based on Rectus Sheath Block in Open Upper Abdominal Surgery:A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Consumption
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Opiate consumption
timeFrame: From the beginning to the end of anesthesia,up to 6 hours.
measure: Tumor recurrence rate
timeFrame: 1-year after surgery
Secondary outcomes:
measure: Opiate consumption
timeFrame: From the end of anesthesia to 48 hours after surgery, up to 2 days.
measure: Pain scores
timeFrame: 2 hours after surgery
measure: Pain scores
timeFrame: 6 hours after surgery
measure: Pain scores
timeFrame: 12 hours after surgery
measure: Pain scores
timeFrame: 24 hours after surgery
measure: Pain scores
timeFrame: 36 hours after surgery
measure: Pain scores
timeFrame: 48 hours after surgery
measure: Time for first to press pump
timeFrame: Up to 2 days after surgery
measure: Time of anal exsufflation
timeFrame: Up to 7 days after surgery
measure: Delirium
timeFrame: Up to 7 days after surgery
measure: The occurrence of nausea and vomiting
timeFrame: Up to 7 days after surgery
measure: The occurrence of cardiovascular or cerebrovascular events
timeFrame: From the end of surgery to the time the patients discharge, up to 1 month.
measure: Length of hospital stay
timeFrame: From the end of surgery to the time the patients discharge, up to 1 month.
measure: Mortality
timeFrame: 30-day after surgery
measure: Mortality
timeFrame: 1-year after surgery
measure: Concentration of norepinephrine
timeFrame: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
measure: Concentration of epinephrine
timeFrame: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
measure: Concentration of cortisol
timeFrame: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
measure: Concentration of tumor necrosis factor-α
timeFrame: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
measure: Concentration of interleukin-6
timeFrame: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Guanghong Xu, MD.PHD
role: PRINCIPAL_INVESTIGATOR
References: