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

August 22, 2021 updated by: The First Affiliated Hospital of Anhui Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opiate consumption
Time Frame: From the beginning to the end of anesthesia,up to 6 hours.
Remifentanil consumption
From the beginning to the end of anesthesia,up to 6 hours.
Tumor recurrence rate
Time Frame: 1-year after surgery
Tumor recurrence rate after surgery
1-year after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opiate consumption
Time Frame: From the end of anesthesia to 48 hours after surgery, up to 2 days.
Sufentanil consumption
From the end of anesthesia to 48 hours after surgery, up to 2 days.
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.
2 hours after surgery
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.
6 hours after surgery
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.
12 hours after surgery
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.
24 hours after surgery
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.
36 hours after surgery
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.
48 hours after surgery
Time for first to press pump
Time Frame: Up to 2 days after surgery
Time for first to press pump
Up to 2 days after surgery
Time of anal exsufflation
Time Frame: Up to 7 days after surgery
Time for first anal exsufflation
Up to 7 days after surgery
Delirium
Time Frame: Up to 7 days after surgery
Incidence of postoperative delirium
Up to 7 days after surgery
The occurrence of nausea and vomiting
Time Frame: Up to 7 days after surgery
Incidence of nausea and vomiting
Up to 7 days after surgery
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
From the end of surgery to the time the patients discharge, up to 1 month.
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
From the end of surgery to the time the patients discharge, up to 1 month.
Mortality
Time Frame: 30-day after surgery
Mortality after surgery
30-day after surgery
Mortality
Time Frame: 1-year after surgery
Mortality after surgery
1-year 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
Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
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
Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
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
Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
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
Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.
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
Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Anhui Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guanghong Xu, MD.PHD, The First Affiliated Hospital of Anhui Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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