Effect of the Sheath of Rectus Abdominis Block Combined With the Transverse Plane

April 14, 2021 updated by: Zhangyi, Tongji Hospital

Effect of the Sheath of Rectus Abdominis Block Combined With the Transverse Plane Block on the Condition in Laparoscopic Gynecological Surgery.

The situation of demand for surgical conditions is quite high when lymph node resection involved in the surgery type, especially abdominal aortic lymph node dissection, and commonly, the surgeons complained about the interference from the intestine which pushed the investigators to increase the level of neuromuscular blockade close to deep NMB. To avoid the application of deep NMB and promote good surgical conditions for laparoscopic gynecological surgery with lymph nodes resection, the investigators explored other preoperative ways to cooperate with surgeons more harmoniously. It's well known that epidural anesthesia and epidural anesthesia combined with spinal anesthesia have the effect of muscle relaxation which has been applied in clinical practice widely. One study indicated that the Transverse Abdominal Plane (TAP) block could change muscle thickness and achieve the effect of muscle relaxation. It leads investigators to a hypothesis that the sheath of rectus abdominis block combined with transverse abdominal plane block may suppress the signal transmission of abdominal nerve, and may be beneficial to improve surgical conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

The investigators conducted this study to test the hypothesis that compared with moderate NMB， the sheath of rectus abdominis block combined with transverse abdominal plane block may reduce the frequency of additional ask for muscle relaxants to optimize surgical conditions, and also provide postoperative analgesia on the premise of moderate NMB.

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 (Anticipated)

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.
42

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

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. ASA grade I~ II;
  2. aged 18-55 years;
  3. BMI 19 ~ 23kg/m2;
  4. laparoscopic total hysterectomy and bilateral adnexectomy and/or pelvic lymphadenectomy under elective general anesthesia lasted for more than 2 hours; 5. informed consent has been signed.

Exclusion Criteria:

  1. the patient had a history of abdominal surgery;
  2. For patients who are professional athletes and weight trainers, abdominal muscle tension can be changed through strength training need to be excluded.
  3. allergic to any of the drugs used in the experiment;
  4. pregnant or lactating women;
  5. patients with severe mental and neurological symptoms cannot cooperate with the study;
  6. those who participated in other clinical trials within 3 months before being enrolled in the study;
  7. the researcher believes that other reasons are not suitable for clinical trials;
  8. patients who have changed their surgical methods or received only palliative surgical treatment;
  9. patients with abnormal coagulation function;

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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.
Experimental: the group of abdominal nerve block combined with moderate NMB
The patients of group N-M received the rectus abdominis block combined with transverse plane block.
Procedure: abdominal nerve block
All Patients of group A-M will be administered with rectus abdominis block combined with TAPB after anesthesia. Rocuronium was infused continuously (concentration: 1 mg/ml) when TOF recovered to 1. The starting rate was 0.3mg/kg/h, and the TOF count was maintained between 1~3 (moderate NMB) and recorded during the operation. Whether and how to add rocuronium was based on TOF count and request of surgeons. When TOF Watch- SX showed 4 or ratio, the investigators increased the speed of rocuronium pump infusion and record the score at the time of shallow NMB. When the chief surgeon thought the vision could not satisfy the needs of the operation, rocuronium 0.1mg/kg in bolus was added as a rescue. Then, the pump speed was lowered or even decreased to 0 to make the TOF count recover to 1~3 as soon as possible.
Other Names:
  • moderate NMB monitorted by the TOF Watch- SX
  • Rocuronium
  • 40 ml of 0.5% ropivacaine
No Intervention: moderate NMB group
The patients of group M received moderate NMB through the surgery.

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
the good or optimal percentage of each group based on the surgical rating scale (5-point scale)
Time Frame: The field of vision was assessed every 15 minutes, from the beginning of the pneumoperitoneum to the end of the pneumoperitoneum. The surgeon gave a score, and the field of vision grade was determined based on the mean value.
The primary outcome was the frequency of the good or optimal rating scale based on a five-point surgical rating scale (SRS) ranging from 1 (extremely poor conditions) to 5 (optimal conditions).
The field of vision was assessed every 15 minutes, from the beginning of the pneumoperitoneum to the end of the pneumoperitoneum. The surgeon gave a score, and the field of vision grade was determined based on the mean value.

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.
Tongji Hospital

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 (Anticipated)

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.
July 31, 2021

Primary Completion (Anticipated)

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, 2022

Study Completion (Anticipated)

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 10, 2022

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).
March 25, 2021

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.
April 14, 2021

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.
April 20, 2021

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.
April 20, 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.
April 14, 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.
April 1, 2021

More Information

Terms related to this study

Keywords

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.
  • 1900026767

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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