ClinicalTrials.gg
RecruitingNCT04238780Updated Sep 13, 2023

Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation

An interventional study of Erector Spinae Plane Block and Intravenous fentanyl patient control device in Postoperative Pain, sponsored by Gachon University Gil Medical Center. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Gachon University Gil Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2020; still recruiting 6 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Gachon University Gil Medical Center is the lead sponsor of 90 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • sensitivity to local anesthetic, bleeding disorders , receiving anticoagulant, (BMI) over 35/kg/m2 spine or chest wall deformity pregnancy tolerance to opioid analgesics inability to use patient-controlled analgesia (PCA)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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: Erector Spinae Plane Block · Procedure: Intravenous fentanyl patient control device

  • 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

Interventions

  • ProcedureErector 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.

  • ProcedureIntravenous fentanyl patient control device

    24-hour fentanyl consumption will be recorded.

06

What researchers measure

Primary outcomes

  1. numerical rating scale on rest and cough

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

    Time frame: 24 hours after surgery

Secondary outcomes

  1. opioid consumption

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

    Time frame: 24 hours after surgery

  2. Quality of Recovery

    pre operative QoR 40 scores compares

    Time frame: 1day before operation, post op 24 hours

  3. need for analgesics

    Number of patients who required analgesic in the first 24 hour

    Time frame: 24 hours after surgery

07

Study locations

1 of 1 sites recruiting
  • Gachon University College of Medicine, Gil Hospital
    Incheon, 21565, Korea, Republic of
    Recruiting
    • jungju choi, MD,PHD · Contactjjchoi2@gilhospital.com · 82324603637
    • hyung jeong kwak, MD,PHD · Contact82324603637
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2020 to primary completion in Jun 2023, 40 months.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 40 months is above that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2020
First posted
Jan 23, 2020
StartActual
Feb 20, 2020
Primary completionActual
Jun 20, 2023
CompletionEst.
Dec 20, 2023
Last update
Sep 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04238780
Lead sponsor
Gachon University Gil Medical Center
Responsible party
Jung Ju Choi (assistance professor, Gachon University Gil Medical Center) — Principal investigator
First posted
Jan 23, 2020
Start date
Feb 20, 2020
Primary completion
Jun 20, 2023
Completion
Dec 20, 2023 (estimated)
Last update
Sep 13, 2023

Study contacts

jungju choi, nd,phd
Contact
jjchoi2@gilhospital.com
8232 460 3624
hyunjeong kwack, md,phd
study director · Gachon University Gil Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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