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NCT Number: NCT04306159

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

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.

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Key information

Conditions

Opioid Consumption

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subcostal TAP

Procedure

Subcostal transversus abdominis plane block

Modified RSB

Procedure

Rectus Sheath Block under the guidance of surgical incision

General anesthesia

Other

Traditional general anesthesia management

Primary outcomes

  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 outcomes

  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

    • 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.

  3. Pain scores

    Time frame: 6 hours after surgery

    • 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.

  4. Pain scores

    Time frame: 12 hours after surgery

    • 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.

  5. Pain scores

    Time frame: 24 hours after surgery

    • 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. Pain scores

    Time frame: 36 hours after surgery

    • 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.

  7. Pain scores

    Time frame: 48 hours after surgery

    • 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.

  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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2020
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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