Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation

Ultrasound Guided Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation: A Randomized Controlled Study

The goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Intravenous fentanyl patient control device; Procedure: Erector Spinae Plane Block

Detailed Description

.The goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery.

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

Contacts and Locations

• Study Contact: Name: jungju choi, nd,phd; Phone Number: 8232 460 3624; Email: jjchoi2@gilhospital.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 21565
    • Recruiting
    • Gachon University College of Medicine, Gil Hospital
    • Contact: jungju choi, MD,PHD; Phone Number: 82324603637; Email: jjchoi2@gilhospital.com
    • Contact: hyung jeong kwak, MD,PHD; Phone Number: 82324603637

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged between 20 and 70 years, with an American Society of Anesthesiologists physical status of 1 or 2, who were scheduled for laparoscopic colorectal operation

Exclusion Criteria:

• sensitivity to local anesthetic, bleeding disorders , receiving anticoagulant, body mass index (BMI) over 35/kg/m2 spine or chest wall deformity pregnancy tolerance to opioid analgesics inability to use patient-controlled analgesia (PCA)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESP( Erector Spinae Plane Block); After induction parturient in the ESPB underwent bilateral ESPB at the level of T7 using a linear ultrasound (US) transducer. Intravenous fentanyl patient control device 24-hour fentanyl consumption will be recorded.	Procedure: Intravenous fentanyl patient control device; 24-hour fentanyl consumption will be recorded.; Procedure: Erector Spinae Plane Block; The transducer was placed vertically 3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine needle was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml local anesthetics is done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back.
Active Comparator: control group; No regional anesthesia technique will be applied to the control group. Intravenous fentanyl patient control device 24-hour fentanyl consumption will be recorded.	Procedure: Intravenous fentanyl patient control device; 24-hour fentanyl consumption will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numerical rating scale on rest and cough	In the recovery room, post op 6hours, post op 24 hours	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption	In the recovery room, post op 6hours, post op 24 hours	24 hours after surgery
Quality of Recovery	pre operative QoR 40 scores compares	1day before operation, post op 24 hours
need for analgesics	Number of patients who required analgesic in the first 24 hour	24 hours after surgery

Collaborators and Investigators

• Sponsor: Gachon University Gil Medical Center
• Investigators: Study Director: hyunjeong kwack, md,phd, Gachon University Gil Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): June 20, 2023
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: ESPlapaAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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