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CompletedNCT03781687Updated Nov 25, 2019

Bilateral vs. Unilateral Erector Spinae Plane Block

An interventional study of Bilateral ESP Block and Unilateral ESP Block in Postoperative Pain and Cholecystitis; Gallstone, sponsored by Kocaeli University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-25.

Sponsored by Kocaeli University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The importance of multimodal analgesia for postoperative pain management is well known and regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But two injections can be unconfortable for some patients. With this study, we aimed to compare the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.

02

Conditions studied

  • Postoperative Pain
  • Cholecystitis; Gallstone

Keywords

  • erector spinae plane block
  • postoperative pain
  • laparoscopic cholecystectomy
03

In context

Pain, Postoperative

5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's enrollment of 90 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Kocaeli University is the lead sponsor of 214 studies on the registry; 39 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 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

  • ASA I-II patients
  • Pateints undergoing elective laparoscopic cholecystectomy

Exclusion criteria

Exclusion Criteria:

  • obesity (body mass index >35 kg/m2)
  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • recent use of analgesic drugs
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Bilateral

    Bilateral ESP block will be performed

    Procedure: Bilateral ESP Block · Device: Intravenous Morphine patient controlled analgesia device

  • Active comparator
    Unilateral

    Unilateral ESP block will be performed

    Procedure: Unilateral ESP Block · Device: Intravenous Morphine patient controlled analgesia device

Interventions

  • ProcedureBilateral ESP Block

    Bilateral ESP Block will be performed at T8

  • ProcedureUnilateral ESP Block

    Unilateral ESP Block will be performed at T8 (right side)

  • DeviceIntravenous Morphine patient controlled analgesia device

    24 hour morphine consumption will be recorded

06

What researchers measure

Primary outcomes

  1. Morphine consumption

    Morphine consumption will be recorded

    Time frame: preoperative 24th hour

Secondary outcomes

  1. Numeric Rating Scale

    A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.

    Time frame: postoperative 24th hour

07

Study locations

1 site
  • Kocaeli University Hospital
    İzmit, Kocaeli 41340, Turkey (Türkiye)
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 Jan 2019 to primary completion in Jun 2019, 5 months.

Of 1,888 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 5 months is below that.

Counting every sponsor, half of 1,901 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
Dec 18, 2018
First posted
Dec 20, 2018
StartActual
Jan 2, 2019
Primary completionActual
Jun 28, 2019
CompletionActual
Jun 29, 2019
Last update
Nov 25, 2019
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 Nov 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03781687
Lead sponsor
Kocaeli University
Responsible party
Can AKSU (Assistant Professor, Kocaeli University) — Principal investigator
First posted
Dec 20, 2018
Start date
Jan 2, 2019
Primary completion
Jun 28, 2019
Completion
Jun 29, 2019
Last update
Nov 25, 2019

Study contacts

Can Aksu
principal investigator · Kocaeli Üniversitesi Tıp Fakültesi

Oversight

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

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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