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

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ClinicalTrials.gov Identifier: NCT04306159
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Anhui Medical University

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.

Condition or disease Intervention/treatment Phase
Opioid Consumption Procedure: Subcostal TAP Procedure: Modified RSB Other: General anesthesia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application of Opioid-sparing Multimodal Anesthesia Based on Rectus Sheath Block in Open Upper Abdominal Surgery:A Randomized Controlled Study
Actual Study Start Date : March 15, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 30, 2020

Arm Intervention/treatment
Sham Comparator: General anesthesia
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
Traditional general anesthesia management

Experimental: Subcostal TAP combined with General anesthesia
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
Subcostal transversus abdominis plane block

Experimental: Modified RSB combined with General anesthesia
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
Rectus Sheath Block under the guidance of surgical incision




Primary Outcome Measures :
  1. Opiate consumption [ Time Frame: From the beginning to the end of anesthesia,up to 6 hours. ]
    Remifentanil consumption

  2. Tumor recurrence rate [ Time Frame: 1-year after surgery ]
    Tumor recurrence rate after surgery


Secondary Outcome Measures :
  1. Opiate consumption [ Time Frame: From the end of anesthesia to 48 hours after surgery, up to 2 days. ]
    Sufentanil consumption

  2. Pain scores [ Time Frame: 2 hours after surgery ]
    1. Through visual analogue scale (from 0 to 10) to assess the degree of pain;
    2. The number 0 means no pain and the number 10 means the most pain;
    3. Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.

  3. Pain scores [ Time Frame: 6 hours after surgery ]
    1. Through visual analogue scale (from 0 to 10) to assess the degree of pain;
    2. The number 0 means no pain and the number 10 means the most pain;
    3. Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.

  4. Pain scores [ Time Frame: 12 hours after surgery ]
    1. Through visual analogue scale (from 0 to 10) to assess the degree of pain;
    2. The number 0 means no pain and the number 10 means the most pain;
    3. Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.

  5. Pain scores [ Time Frame: 24 hours after surgery ]
    1. Through visual analogue scale (from 0 to 10) to assess the degree of pain;
    2. The number 0 means no pain and the number 10 means the most pain;
    3. Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.

  6. Pain scores [ Time Frame: 36 hours after surgery ]
    1. Through visual analogue scale (from 0 to 10) to assess the degree of pain;
    2. The number 0 means no pain and the number 10 means the most pain;
    3. Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.

  7. Pain scores [ Time Frame: 48 hours after surgery ]
    1. Through visual analogue scale (from 0 to 10) to assess the degree of pain;
    2. The number 0 means no pain and the number 10 means the most pain;
    3. Patients with visual analogue scale greater than 3 points should have remedial analgesic drugs.

  8. Time for first to press pump [ Time Frame: Up to 2 days after surgery ]
    Time for first to press pump

  9. Time of anal exsufflation [ Time Frame: Up to 7 days after surgery ]
    Time for first anal exsufflation

  10. Delirium [ Time Frame: Up to 7 days after surgery ]
    Incidence of postoperative delirium

  11. The occurrence of nausea and vomiting [ Time Frame: Up to 7 days after surgery ]
    Incidence of nausea and vomiting

  12. The occurrence of cardiovascular or cerebrovascular events [ Time Frame: From the end of surgery to the time the patients discharge, up to 1 month. ]
    Incidence of cardiovascular or cerebrovascular adverse events

  13. Length of hospital stay [ Time Frame: From the end of surgery to the time the patients discharge, up to 1 month. ]
    Length of hospital stay

  14. Mortality [ Time Frame: 30-day after surgery ]
    Mortality after surgery

  15. Mortality [ Time Frame: 1-year after surgery ]
    Mortality after surgery

  16. Concentration of norepinephrine [ Time Frame: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity. ]
    Concentration of norepinephrine during surgery

  17. Concentration of epinephrine [ Time Frame: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity. ]
    Concentration of epinephrine during surgery

  18. Concentration of cortisol [ Time Frame: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity. ]
    Concentration of cortisol during surgery

  19. Concentration of tumor necrosis factor-α [ Time Frame: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity. ]
    Concentration of tumor necrosis factor-α during surgery

  20. Concentration of interleukin-6 [ Time Frame: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity. ]
    Concentration of interleukin-6 during surgery



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306159


Contacts
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Contact: Guanghong Xu, MD.PHD 0551-62922344 xuguanghong2004@163.com

Locations
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China, Anhui
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China
Contact: Qi X Cheng         
Principal Investigator: Hong G Xu         
Sponsors and Collaborators
The First Affiliated Hospital of Anhui Medical University
Investigators
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Principal Investigator: Guanghong Xu, MD.PHD The First Affiliated Hospital of Anhui Medical University
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Responsible Party: The First Affiliated Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT04306159    
Other Study ID Numbers: 201911
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs