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Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Intravenous fentanyl patient control device
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Gachon University College of Medicine, Gil HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESP( Erector Spinae Plane Block)

control group

Arm Description

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.

No regional anesthesia technique will be applied to the control group. Intravenous fentanyl patient control device 24-hour fentanyl consumption will be recorded.

Outcomes

Primary Outcome Measures

numerical rating scale on rest and cough
In the recovery room, post op 6hours, post op 24 hours

Secondary Outcome Measures

opioid consumption
In the recovery room, post op 6hours, post op 24 hours
Quality of Recovery
pre operative QoR 40 scores compares
need for analgesics
Number of patients who required analgesic in the first 24 hour

Full Information

First Posted
January 20, 2020
Last Updated
September 11, 2023
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04238780
Brief Title
Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation
Official Title
Ultrasound Guided Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESP( Erector Spinae Plane Block)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
No regional anesthesia technique will be applied to the control group. Intravenous fentanyl patient control device 24-hour fentanyl consumption will be recorded.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intravenous fentanyl patient control device
Intervention Description
24-hour fentanyl consumption will be recorded.
Primary Outcome Measure Information:
Title
numerical rating scale on rest and cough
Description
In the recovery room, post op 6hours, post op 24 hours
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
opioid consumption
Description
In the recovery room, post op 6hours, post op 24 hours
Time Frame
24 hours after surgery
Title
Quality of Recovery
Description
pre operative QoR 40 scores compares
Time Frame
1day before operation, post op 24 hours
Title
need for analgesics
Description
Number of patients who required analgesic in the first 24 hour
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jungju choi, nd,phd
Phone
8232 460 3624
Email
jjchoi2@gilhospital.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hyunjeong kwack, md,phd
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Gachon University College of Medicine, Gil Hospital
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jungju choi, MD,PHD
Phone
82324603637
Email
jjchoi2@gilhospital.com
First Name & Middle Initial & Last Name & Degree
hyung jeong kwak, MD,PHD
Phone
82324603637

12. IPD Sharing Statement

Plan to Share IPD
No

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Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation

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