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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04306159
Enrollment
126
Registered
2020-03-12
Start date
2020-03-15
Completion date
2021-08-16
Last updated
2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Consumption

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.

Interventions

PROCEDURESubcostal TAP

Subcostal transversus abdominis plane block

PROCEDUREModified RSB

Rectus Sheath Block under the guidance of surgical incision

OTHERGeneral anesthesia

Traditional general anesthesia management

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Opiate consumptionFrom the beginning to the end of anesthesia,up to 6 hours.Remifentanil consumption
Tumor recurrence rate1-year after surgeryTumor recurrence rate after surgery

Secondary

MeasureTime frameDescription
Time for first to press pumpUp to 2 days after surgeryTime for first to press pump
Time of anal exsufflationUp to 7 days after surgeryTime for first anal exsufflation
DeliriumUp to 7 days after surgeryIncidence of postoperative delirium
The occurrence of nausea and vomitingUp to 7 days after surgeryIncidence of nausea and vomiting
The occurrence of cardiovascular or cerebrovascular eventsFrom the end of surgery to the time the patients discharge, up to 1 month.Incidence of cardiovascular or cerebrovascular adverse events
Length of hospital stayFrom the end of surgery to the time the patients discharge, up to 1 month.Length of hospital stay
Opiate consumptionFrom the end of anesthesia to 48 hours after surgery, up to 2 days.Sufentanil consumption
Concentration of norepinephrineTime before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.Concentration of norepinephrine during surgery
Concentration of epinephrineTime before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.Concentration of epinephrine during surgery
Concentration of cortisolTime 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-αTime 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-6Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.Concentration of interleukin-6 during surgery
Mortality30-day after surgeryMortality after surgery
Pain scores2 hours after surgery1. 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026