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

Not Applicable

• Conditions: Nerve Block; Surgical Conditions
• Interventions: Procedure: abdominal nerve block

• Registration Number: NCT04850404
• Lead Sponsor: Tongji Hospital

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.

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 Timeline

• Study First Submitted: 2021-03-25
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-14
• Last Update Submitted: 2021-04-14
• Study First Posted: 2021-04-20
• Last Update Posted: 2021-04-20
• Study Start: 2021-07-31
• Primary Completion: 2022-07-30
• Study Completion: 2022-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the group of abdominal nerve block combined with moderate NMB	abdominal nerve block	The patients of group N-M received the rectus abdominis block combined with transverse plane block.

Primary Outcome Measures

Name	Time	Method
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).