Nerve BlockNCT04850404
Effect of the Sheath of Rectus Abdominis Block Combined With the Transverse Plane
A study testing abdominal nerve block in people with Nerve Block and Surgical Conditions, run by Tongji Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Nerve Block, Surgical Conditions
- What is being tested?
- abdominal nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2021to 10 Aug 2022
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA grade I~ II;
- aged 18-55 years;
- BMI 19 ~ 23kg/m2;
- 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.
Who cannot join
- the patient had a history of abdominal surgery;
- For patients who are professional athletes and weight trainers, abdominal muscle tension can be changed through strength training need to be excluded.
- allergic to any of the drugs used in the experiment;
- pregnant or lactating women;
- patients with severe mental and neurological symptoms cannot cooperate with the study;
- those who participated in other clinical trials within 3 months before being enrolled in the study;
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- the researcher believes that other reasons are not suitable for clinical trials;
- patients who have changed their surgical methods or received only palliative surgical treatment;
- patients with abnormal coagulation function;
About this study
Official title: 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.
Read the 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.
- Conditions
- Nerve Block, Surgical Conditions
- Being tested
- abdominal nerve block
- Keywords
- TAPB, Moderate NMB, Surgical conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal nerve blockProcedure or surgery
Also called moderate NMB monitorted by the TOF Watch- SX, Rocuronium, 40 ml of 0.5% ropivacaine
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.
| Study group | Role | What they receive |
|---|---|---|
| the group of abdominal nerve block combined with moderate NMB | Experimental | The patients of group N-M received the rectus abdominis block combined with transverse plane block. Receives: Procedure: abdominal nerve block |
| moderate NMB group | No intervention | The patients of group M received moderate NMB through the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the good or optimal percentage of each group based on the surgical rating scale (5-point scale)
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start31 Jul 2021 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion10 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhangyi, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850404
- Sponsor's protocol ID
- 1900026767
- Status last verified
- Apr 2021
- First submitted
- 25 Mar 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Sheath of Rectus Abdominis Block Combined With the Transverse Plane Block on the Condition in Laparoscopic Gynecological Surgery.
- ClinicalTrials.gov ID
- NCT04850404
- Acronym / sponsor ID
- 1900026767
- Conditions
- Nerve Block, Surgical Conditions
- Keywords
- TAPB, Moderate NMB, Surgical conditions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 31 Jul 2021 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 10 Aug 2022 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the group of abdominal nerve block combined with moderate NMB | Experimental | Procedure: abdominal nerve blockThe patients of group N-M received the rectus abdominis block combined with transverse plane block. |
| moderate NMB group | No intervention | –The patients of group M received moderate NMB through the surgery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA grade I~ II;
- aged 18-55 years;
- BMI 19 ~ 23kg/m2;
- 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.
Key exclusion criteria (9 listed)
- the patient had a history of abdominal surgery;
- For patients who are professional athletes and weight trainers, abdominal muscle tension can be changed through strength training need to be excluded.
- allergic to any of the drugs used in the experiment;
- pregnant or lactating women;
- patients with severe mental and neurological symptoms cannot cooperate with the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal nerve blockAlso: moderate NMB monitorted by the TOF Watch- SX, Rocuronium, 40 ml of 0.5% ropivacaineAll 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. | Procedure or surgery | the group of abdominal nerve block combined with moderate NMB |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal nerve block in people with Nerve Block and Surgical Conditions, run by Tongji Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2021.