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

Opioid Consumption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306159
• Other study ID #: 201911
• Status: Completed
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: August 16, 2021

Study information

• Verified date: March 2020
• Source: The First Affiliated Hospital of Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 16, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Consumption

Intervention

Procedure:
• Subcostal TAP
Subcostal transversus abdominis plane block
• Modified RSB
Rectus Sheath Block under the guidance of surgical incision

Other:
• General anesthesia
Traditional general anesthesia management

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate consumption	Remifentanil consumption	From the beginning to the end of anesthesia,up to 6 hours.
Primary	Tumor recurrence rate	Tumor recurrence rate after surgery	1-year after surgery
Secondary	Opiate consumption	Sufentanil consumption	From the end of anesthesia to 48 hours after surgery, up to 2 days.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time for first to press pump	Time for first to press pump	Up to 2 days after surgery
Secondary	Time of anal exsufflation	Time for first anal exsufflation	Up to 7 days after surgery
Secondary	Delirium	Incidence of postoperative delirium	Up to 7 days after surgery
Secondary	The occurrence of nausea and vomiting	Incidence of nausea and vomiting	Up to 7 days after surgery
Secondary	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.
Secondary	Length of hospital stay	Length of hospital stay	From the end of surgery to the time the patients discharge, up to 1 month.
Secondary	Mortality	Mortality after surgery	30-day after surgery
Secondary	Mortality	Mortality after surgery	1-year after surgery
Secondary	Concentration of norepinephrine	Concentration of norepinephrine during surgery	Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
Secondary	Concentration of epinephrine	Concentration of epinephrine during surgery	Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
Secondary	Concentration of cortisol	Concentration of cortisol during surgery	Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
Secondary	Concentration of tumor necrosis factor-a	Concentration of tumor necrosis factor-a during surgery	Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
Secondary	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.