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

NCT04850404 | Unknown

• 1 other identifier: 1900026767
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Nerve Block; Surgical Conditions

Keywords

TAPB; Moderate NMB; Surgical conditions

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

Study Arms (2)

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.

Procedure: abdominal nerve block

moderate NMB group

NO INTERVENTION

The patients of group M received moderate NMB through the surgery.

Interventions

abdominal nerve block PROCEDURE

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.

Also known as: moderate NMB monitorted by the TOF Watch- SX, Rocuronium, 40 ml of 0.5% ropivacaine

the group of abdominal nerve block combined with moderate NMB

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Interventions

Rocuronium; Ropivacaine

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 20, 2021
• Study Start: July 31, 2021
• Primary Completion: July 30, 2022
• Study Completion: August 10, 2022
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share