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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

Tracking Information
First Submitted Date  ICMJE February 29, 2020
First Posted Date  ICMJE March 12, 2020
Last Update Posted Date April 8, 2020
Actual Study Start Date  ICMJE March 15, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Opiate consumption [ Time Frame: From the beginning to the end of anesthesia,up to 6 hours. ]
    Remifentanil consumption
  • Tumor recurrence rate [ Time Frame: 1-year after surgery ]
    Tumor recurrence rate after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Opiate consumption [ Time Frame: From the end of anesthesia to 48 hours after surgery, up to 2 days. ]
    Sufentanil consumption
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Time for first to press pump [ Time Frame: Up to 2 days after surgery ]
    Time for first to press pump
  • Time of anal exsufflation [ Time Frame: Up to 7 days after surgery ]
    Time for first anal exsufflation
  • Delirium [ Time Frame: Up to 7 days after surgery ]
    Incidence of postoperative delirium
  • The occurrence of nausea and vomiting [ Time Frame: Up to 7 days after surgery ]
    Incidence of nausea and vomiting
  • 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
  • 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
  • Mortality [ Time Frame: 30-day after surgery ]
    Mortality after surgery
  • Mortality [ Time Frame: 1-year after surgery ]
    Mortality after surgery
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application of Rectus Sheath Block based-on Incision in Upper Abdominal Surgery
Official Title  ICMJE Application of Opioid-sparing Multimodal Anesthesia Based on Rectus Sheath Block in Open Upper Abdominal Surgery:A Randomized Controlled Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Opioid Consumption
Intervention  ICMJE
  • Procedure: Subcostal TAP
    Subcostal transversus abdominis plane block
  • Procedure: Modified RSB
    Rectus Sheath Block under the guidance of surgical incision
  • Other: General anesthesia
    Traditional general anesthesia management
Study Arms  ICMJE
  • 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.
    Intervention: Other: General anesthesia
  • 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.
    Intervention: Procedure: Subcostal TAP
  • 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.
    Intervention: Procedure: Modified RSB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guanghong Xu, MD.PHD 0551-62922344 xuguanghong2004@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04306159
Other Study ID Numbers  ICMJE 201911
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The First Affiliated Hospital of Anhui Medical University
Study Sponsor  ICMJE The First Affiliated Hospital of Anhui Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guanghong Xu, MD.PHD The First Affiliated Hospital of Anhui Medical University
PRS Account The First Affiliated Hospital of Anhui Medical University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP