The Effect and Safety of the Four Points Transversus Abdominis Plane Block

NCT03598192 | Completed DMC

• 1 other identifier: 15-2018/CN-HĐĐĐ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The anterior abdominal wall from below the xiphoid to infraumbilical area is dominated by the sensory nerves which originate from the anterior rami of the thoracolumbar spinal nerves from T6-L1. The branches nerves from T7-T12 are between aponeurosis internal oblique and transversus abdominal muscle. They can be approached with the ultrasound guidance at subcostal and lateral abdominal wall position. The bilateral transversus abdominis plane (TAP) block has been demonstrated effectiveness and safety in postoperative analgesia to the under abdominal surgery. However, the effect of one to the upper abdominal surgery is unclear. The four points TAP block has been described the first in 2010. The effect of the four points TAP block in postoperative analgesia to the upper abdominal surgery has been reported in recent years. Besides, the effect of thoracic paravertebral block (PVB) in postoperative analgesia to liver resection was also reported. The both techniques have been performing in some studies. The effect and safety of the both techniques have been reported. However, the evidence level is still weak. The investigators need to find a technique, which has effectiveness as well as safety to replace the epidural analgesia, which was confirmed that had many complications, in postoperative analgesia to the hepatectomy. The investigators hypothesized that the four points TAP block under the ultrasound guidance has more effectiveness than the thoracic paravertebral block in postoperative analgesia to the hepatectomy.

Conditions

Liver Diseases; Adult Disease

Keywords

Hepatectomy; Transversus abdominis plane block (TAP block); Paravertebral block; Postoperative analgesia; Liver resection

Outcome Measures

Primary Outcomes (1)

• The consumption of sulfentanil (mean)

  The consumption of sufentanil is total dose of sufentanil which the participant used during 24 hours. Sufentanil is intravenously infused with PCA, with single dose 1 mcg, limit dose 8 mcg per a hour, and lockout time 5 minutes.

  24 hours

Secondary Outcomes (3)

• The complications of technique (frequency)

  24 hours

• Side-effect of sulfentanil (frequency)

  48 hours

• Satisfaction (mean)

  24 hours

Study Arms (2)

TAP group

EXPERIMENTAL

The TAP block is performed under the ultrasound guidance at four points: at subcostal and lateral abdominal wall at right-side and left-side. Drug: ropivacaine 0.375% 40 ml (maximum dose \<= 3 mg/kg). Maintenance: ropivacaine 0.375% 8 ml/hour during 48 hours.

Procedure: TAP; Drug: Ropivacaine; Drug: Sufentanil

PVB group

EXPERIMENTAL

The paravertebral block is performed under the ultrasound guidance at T7. Drug: ropivacaine 0.5% 20 ml (maximum dose \<= 3 mg/kg). Maintenance: ropivacaine 0.25% 8 ml/hour during 48 hours.

Procedure: PVB; Drug: Ropivacaine; Drug: Sufentanil

Interventions

TAP PROCEDURE

The TAP group will be performed at four points at abdominis plane with ropivacaine 0.375%

Also known as: The four points TAP block

TAP group

PVB PROCEDURE

The PVB group will be performed at paravertebral space T7 with ropivacaine 0.5%

Also known as: The paravertebral block

PVB group

Ropivacaine DRUG

Ropivacaine has been treated the both group

Also known as: have not been specified

PVB group; TAP group

Sufentanil DRUG

Sufentanil has been included in Arm/Group Descriptions

Also known as: Sufentanil PCA

PVB group; TAP group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects has selective hepatectomy
• Subjects has had II-III of Anesthesiologists Society Americans

You may not qualify if:

• History of chronic pain
• History of tolerance opioids
• History of psychology disorder
• Allergic to ropivacaine or opioids

Sponsors & Collaborators

• Gia Dinh People Hospital: lead

Study Sites (1)

Binh Huynh

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

Location

MeSH Terms

Conditions

Liver Diseases; Disease

Interventions

Ropivacaine; Sufentanil

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Binh V Huynh, Mr

  Nhan dan Gia Dinh Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Model Details: The TAP group will be performed the four points TAP block under the ultrasound guidance with the ultrasound machine of Logiq E, and linear 12S probe. The participants will be performed TAP block at subcostal and lateral abdominal wall at right and left side with stimuplex needle (sized 18G, length 100 mm). The investigators will approach position between aponeurosis internal oblique and transversus abdominal muscle with in-plane real-time ultrasound technique. The investigators will inject 10 ml of ropivacaine 0.375% at each one. Then, the investigators will access one catheter at TAP at right side to continuously infuse ropivacaine 0.375% during 48 hours after surgery. PVB group: the investigators will access one catheter into the right thoracic paravertebral space at T7 before beginning general anesthesia. At the end of surgery, the investigators will inject 20 ml of ropivacaine 0.5% through catheter, and continuously infuse ropivacaine 0.25% during 48 hours after surgery.

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 26, 2018
• Study Start: August 15, 2018
• Primary Completion: September 1, 2018
• Study Completion: July 30, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

VN (1)