Study of the Clinical Effect of External Oblique Muscle Intercostal Muscle Plane Block in Abdominal Surgery (EOI)

Study of the Clinical Effect of External Oblique Muscle Intercostal Muscle Plane Block in Abdominal Surgery。

This study intends to apply external oblique intercostal muscle plane block in thoracoabdominal resection, and to explore its effect on perioperative analgesia and rehabilitation quality in patients undergoing thoracoabdominal surgery.

Study Overview

• Status: Completed
• Conditions: Pain; Nerve Block
• Intervention / Treatment: Procedure: Intercostal plane block of the external oblique muscle

Detailed Description

Approved by the hospital ethics committee, 60 patients undergoing thoracic and abdominal surgery were selected in this study. They were divided into experimental group (n=30) and control group (n=30). The experimental group was given 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia, and the control group was given 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia. MAP, HR and SPO2 were recorded at admission (T0), completion of induction (T1), skin incision (T2), 30min after operation (T3) and 30min after extubation (T5). The block range of nerve block in the experimental group was recorded. The VAS score and the number of patient-controlled analgesia pump were recorded 30min after extubation, 6h, 24h and 48h after operation in resting state and cough state. Postoperative adverse reactions such as respiratory depression, expectoration weakness, nausea, vomiting, and skin itching were recorded. The first time to get out of bed after operation was recorded.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • The First Hospital of Qinhuangdao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA Physical Status Classification of I-II Aged 18-60 years old ; Will be scheduled to undergo elective LC

Exclusion Criteria:

• Coagulation disorders, Liver/kidney disease, Abdominal surgery history, Infection in the block application area, Chronic opioid use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: External oblique intercostal plane block.; Given 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil + tropisetron 5mg intravenous analgesia.	Procedure: Intercostal plane block of the external oblique muscle; Under ultrasound guidance, a single dose of 0.25% ropivacaine 20ml was given for bilateral intercostal muscle plane block of external oblique muscles
No Intervention: Patient controlled in travenousanalgesia.; Given intravenous analgesia with 2.0ug/kg sufentanil + tropisetron 5 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's postoperative pain score	Using the VIsual Analogue Scale,patients were guided to indicate the corresponding pain score according to their own pain situation, and the score ranged from 0 to 10. To evaluate the degree of postoperative pain, a score of 0 indicates no pain at all, a score of 2 indicates mild pain, and a score of 10 indicates the most severe pain, with higher scores indicating more severe pain	Extubation for 30minutes, 6 hours after surgery, 24 hours after surgery, and 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure	Mean arterial pressure at different time points.Mean arterial pressure will be reported in mmHg.	Perioperative period
Changes in heart rate	Heart rate at different time points.Heart rate will be reported in counts per minute.	Perioperative period
Extent of action of external oblique intercostal muscle plane block	The specific extent of action of the external oblique muscle intercostal muscle plane block in the thoracoabdominal wall.	Ten minutes after the nerve block

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Estimated): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 8, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: WCX123456

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No