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

Sponsor

Tongji Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04850404

Collaborator

(none)

Enrollment

Arms

12.3

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nerve Block Surgical Conditions	Procedure: abdominal nerve block	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 31, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Aug 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

the good or optimal percentage of each group based on the surgical rating scale (5-point scale) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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;