NCT04238780

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

3.3 years

First QC Date

January 20, 2020

Last Update Submit

September 11, 2023

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • numerical rating scale on rest and cough

    In the recovery room, post op 6hours, post op 24 hours

    24 hours after surgery

Secondary Outcomes (3)

  • opioid consumption

    24 hours after surgery

  • Quality of Recovery

    1day before operation, post op 24 hours

  • need for analgesics

    24 hours after surgery

Study Arms (2)

ESP( Erector Spinae Plane Block)

ACTIVE COMPARATOR

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: Erector Spinae Plane BlockProcedure: Intravenous fentanyl patient control device

control group

ACTIVE COMPARATOR

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

Interventions

Erector Spinae Plane BlockPROCEDURE

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.

ESP( Erector Spinae Plane Block)
Intravenous fentanyl patient control devicePROCEDURE

24-hour fentanyl consumption will be recorded.

ESP( Erector Spinae Plane Block)control group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University College of Medicine, Gil Hospital

Incheon, 21565, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • hyunjeong kwack, md,phd

    Gachon University Gil Medical Center

    STUDY DIRECTOR

Central Study Contacts

jungju choi, nd,phd

CONTACT

8232 460 3624jjchoi2@gilhospital.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistance professor

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 23, 2020

Study Start

February 20, 2020

Primary Completion

June 20, 2023

Study Completion

December 20, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)