Application of Rectus Sheath Block based-on Incision in Upper Abdominal Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Application of Opioid-sparing Multimodal Anesthesia Based on Rectus Sheath Block in Open Upper Abdominal Surgery:A Randomized Controlled Study

Conditions
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Opioid Consumption

Intervention / Treatment
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* Procedure: Subcostal TAP
* Procedure: Modified RSB
* Other: General anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: General anesthesia<br>Basal blood pressure and heart rate were recorded after midazolam administration of 0.02 mg/kg. Anesthesia was induced with sufentanil 0.4 μg/kg and propofol 2-2.5 mg/kg, IV route. An IV bolus of cisatracurium 0.1 mg/kg IV was given to facilitate tracheal intubation. Anesthesia was maintained with propofol 4-6 mg/kg/h combined dexmedetomidine 0.2 μg/kg/h(after 0.2 μg/kg/h loading dose within 15min)by bispectral index (BIS) 40-60 and additional bolus doses of remifentanil 0.2-0.5 μg/kg/min to keep arterial pressure values around 20% below baseline values. Sufentanil 0.1-0.2 μg/kg and flurbiprofen 100mg was administrated once the abdomen was closed, then a patient controlled analgesia pump was used. No RSB was performed. | Other: General anesthesia<br>* Traditional general anesthesia management<br>|
| Experimental: Subcostal TAP combined with General anesthesia<br>After induction, TAP was performed. The transversus abdominis plane is imaged with the ultrasound probe obliquely on the upper abdominal wall, along the subcostal margin near the midline.The needle tip was advanced to the desired position where 20 mL 0.375%ropivacaine(Dexamethasone 5mg was added)were injected.The technique is repeated on the opposite side. Anesthesia method and management was same as general anesthesia group. | Procedure: Subcostal TAP<br>* Subcostal transversus abdominis plane block<br>|
| Experimental: Modified RSB combined with General anesthesia<br>After induction, Modified RSB was performed based on midline incision-guided. The rectus muscle is imaged with the ultrasound probe in a transverse orientation below the xiphisternum and above the umbilicus.The needle tip was advanced to the two desired position where 10 mL ropivacaine 0.375% were injected causing hydrodissection of the rectus muscle away from the posterior rectus sheath.The technique is repeated on the opposite side.Anesthesia method and management was same as general anesthesia group. | Procedure: Modified RSB<br>* Rectus Sheath Block under the guidance of surgical incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate consumption | Remifentanil consumption | From the beginning to the end of anesthesia,up to 6 hours. | 
| Tumor recurrence rate | Tumor recurrence rate after surgery | 1-year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate consumption | Sufentanil consumption | From the end of anesthesia to 48 hours after surgery, up to 2 days. | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Time for first to press pump | Time for first to press pump | Up to 2 days after surgery | 
| Time of anal exsufflation | Time for first anal exsufflation | Up to 7 days after surgery | 
| Delirium | Incidence of postoperative delirium | Up to 7 days after surgery | 
| The occurrence of nausea and vomiting | Incidence of nausea and vomiting | Up to 7 days after surgery | 
| 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. | 
| Length of hospital stay | Length of hospital stay | From the end of surgery to the time the patients discharge, up to 1 month. | 
| Mortality | Mortality after surgery | 30-day after surgery | 
| Mortality | Mortality after surgery | 1-year after surgery | 
| Concentration of norepinephrine | Concentration of norepinephrine during surgery | Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity. | 
| Concentration of epinephrine | Concentration of epinephrine during surgery | Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity. | 
| Concentration of cortisol | Concentration of cortisol during surgery | Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity. | 
| Concentration of tumor necrosis factor-α | Concentration of tumor necrosis factor-α during surgery | Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity. | 
| 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. |