Ultrasound-guided Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery

Liver Neoplasms Clinical Trial

— RCT  

Official title:

The Role of Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery: a Randomised Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531864
• Other study ID #: JF20PJ288
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2024
• Source: The First People's Hospital of Neijiang
• Contact: Jiang Fei
• Phone: 18283236053
• Email: 1277636690[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the clinical application of ultrasound-guided continuous low serratus anterior plane block in open surgery for hepatocellular carcinoma.

Description:

METHODS: Patients with hepatocellular carcinoma who attended our hospital from January 2021 to April 2023 were divided into CS group and N group according to the random number table method; CS group underwent ultrasound-guided continuous low anterior serratus plane block and N group underwent ultrasound-guided single anterior serratus plane block combined with rectus abdominis sheath block; the operation time, anesthesia time, incision length, sensory block time and sensory block maintenance time were counted and recorded. Pain score (NRS) was used to detect analgesia; alanine aminotransferase (ALT), liver function aspartate aminotransferase (AST), and prothrombin time (The time of thrombin, NRS) were measured by fluorescent quantitative PCR. （The time of thrombin (APTT), total bilirubin (TBIL) levels and adverse reactions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 18-60 years;

2. ASAI-II;

3. BMI: 18-29 kg/m2

Exclusion Criteria:

1. Combined cardiac, cerebral, hepatic, and renal failure;

2. Comorbid psychiatric and neuromuscular disorders;

3. A history of allergy to anesthetic drugs;

4. Participation in other recent clinical or drug trials.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms
• Postoperative Analgesia
• Serratus Anterior Plane Block

Intervention

Procedure:
• Ultrasound-guided continuous low serratus anterior plane block
Low anterior serratus plane block, move the mid-axillary line 4 and 5 intercostal puncture points are moved down and the puncture is changed to 7 and 8 intercostal.
• Ultrasound-guided single serratus anterior plane block
Ultrasound-guided single anterior saw plane block was performed, and a needle was injected between the 4th and 5th costals in the midaxillary line.

Locations

Country	Name	City	State
China	The First People's Hospital of Neijiang	Neijiang	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Liu Di

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Block plane	The effect of anesthesia after ultrasound-guided nerve block was measured using planimetry, as well as the area being anesthetized. The chest wall between T2-T9 and ice cotton balls was used to assess the extent and extent of anesthesia block.	30 minute after the surgery begins
Primary	visual analogue scale	The visual analogue scale (VAS) of the patient's pain was recorded 24 hours after operation.	24 hours after surgery
Primary	visual analogue scale	The visual analogue scale (VAS) of the patient's pain was recorded 48 hours after operation.	48 hours after surgery.
Primary	visual analogue scale	The visual analogue scale (VAS) of the patient's pain was recorded 36 hours after operation.	36 hours after surgery.
Secondary	Patient satisfaction	The patient's satisfaction with the analgesia 2 days after surgery was recorded. The analgesic effect: 1-3 as satisfactory, 4-6 as unsatisfactory, 7-10 as ineffective	48 hours after surgery.
Secondary	Remedial analgesic drug	Whether other analgesic drugs were added within 24 hours after operation was recorded	24 hours after surgery.
Secondary	Intraoperative blood pressure changes	Blood pressure changes were measured directly by radial artery puncture and recorded.; The changes in blood pressure and heart rate before and after excision and the use of intraoperative opioids.	2 hours after the beginning of surgery.
Secondary	Intraoperative heart rate changes	The curve of the change of the operative heart rate was recorded through the anesthesia machine.	2 hours after the beginning of surgery.