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

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Consumption
• Intervention / Treatment: Other: General anesthesia; Procedure: Subcostal TAP; Procedure: Modified RSB

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: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Anhui Medical University
• Investigators: Principal Investigator: Guanghong Xu, MD.PHD, The First Affiliated Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: February 29, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 201911

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No