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Opioid ConsumptionNCT04306159

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

A study testing Subcostal TAP, Modified RSB and General anesthesia in people with Opioid Consumption, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Opioid Consumption
What is being tested?
Subcostal TAP, Modified RSB and General anesthesia
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
1 siteChina
Study dates
15 Mar 2020to 16 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-85 years
  • Anesthesiologists (ASA) risk classification I to IV
  • Scheduled to undergo midline incision of upper abdomen (From xiphoid to navel )

Who cannot join

  • 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
Show all 9Show fewer
  • Previous open surgery
  • Previous definite history of malignant tumor
  • Who had an estimated intraoperative blood loss of more than 500 mL

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Subcostal TAP, Modified RSB, General anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcostal TAPProcedure or surgery

    Subcostal transversus abdominis plane block

  • Modified RSBProcedure or surgery

    Rectus Sheath Block under the guidance of surgical incision

  • General anesthesiaOther

    Traditional general anesthesia management

Study groups in NCT04306159
Study groupRoleWhat they receive
General anesthesiaSham comparatorBasal 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.
Receives: Other: General anesthesia
Subcostal TAP combined with General anesthesiaExperimentalAfter 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.
Receives: Procedure: Subcostal TAP
Modified RSB combined with General anesthesiaExperimentalAfter 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.
Receives: Procedure: Modified RSB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opiate consumption

    Remifentanil consumption

    Measured: From the beginning to the end of anesthesia,up to 6 hours.

  2. Tumor recurrence rate

    Tumor recurrence rate after surgery

    Measured: 1-year after surgery

Secondary outcomes (20)

  1. Opiate consumption

    Sufentanil consumption

    Measured: From the end of anesthesia to 48 hours after surgery, up to 2 days.

  2. Pain scores

    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.

    Measured: 2 hours after surgery

  3. Pain scores

    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.

    Measured: 6 hours after surgery

  4. Pain scores

    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.

    Measured: 12 hours after surgery

  5. Pain scores

    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.

    Measured: 24 hours after surgery

  6. Pain scores

    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.

    Measured: 36 hours after surgery

  7. Pain scores

    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.

    Measured: 48 hours after surgery

  8. Time for first to press pump

    Time for first to press pump

    Measured: Up to 2 days after surgery

  9. Time of anal exsufflation

    Time for first anal exsufflation

    Measured: Up to 7 days after surgery

  10. Delirium

    Incidence of postoperative delirium

    Measured: Up to 7 days after surgery

  11. The occurrence of nausea and vomiting

    Incidence of nausea and vomiting

    Measured: Up to 7 days after surgery

  12. The occurrence of cardiovascular or cerebrovascular events

    Incidence of cardiovascular or cerebrovascular adverse events

    Measured: From the end of surgery to the time the patients discharge, up to 1 month.

  13. Length of hospital stay

    Length of hospital stay

    Measured: From the end of surgery to the time the patients discharge, up to 1 month.

  14. Mortality

    Mortality after surgery

    Measured: 30-day after surgery

  15. Mortality

    Mortality after surgery

    Measured: 1-year after surgery

  16. Concentration of norepinephrine

    Concentration of norepinephrine during surgery

    Measured: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.

  17. Concentration of epinephrine

    Concentration of epinephrine during surgery

    Measured: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.

  18. Concentration of cortisol

    Concentration of cortisol during surgery

    Measured: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.

  19. Concentration of tumor necrosis factor-α

    Concentration of tumor necrosis factor-α during surgery

    Measured: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.

  20. Concentration of interleukin-6

    Concentration of interleukin-6 during surgery

    Measured: Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2020
  2. Study start15 Mar 2020
  3. Primary completion30 Jul 2021
  4. Study completion16 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04306159
Sponsor's protocol ID
201911
Status last verified
Mar 2020
First submitted
29 Feb 2020
Last updated
24 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Subcostal TAP, Modified RSB and General anesthesia in people with Opioid Consumption, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opiate consumption (time frame: From the beginning to the end of anesthesia,up to 6 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04306159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021; AzTrials last refreshed its copy on 29 Oct 2026.

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