NCT03781687

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

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

December 18, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

December 18, 2018

Last Update Submit

November 21, 2019

Conditions

Postoperative PainCholecystitis; Gallstone

Keywords

erector spinae plane blockpostoperative painlaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    Morphine consumption will be recorded

    preoperative 24th hour

Secondary Outcomes (1)

  • Numeric Rating Scale

    postoperative 24th hour

Study Arms (2)

Bilateral

ACTIVE COMPARATOR

Bilateral ESP block will be performed

Procedure: Bilateral ESP BlockDevice: Intravenous Morphine patient controlled analgesia device

Unilateral

ACTIVE COMPARATOR

Unilateral ESP block will be performed

Procedure: Unilateral ESP BlockDevice: Intravenous Morphine patient controlled analgesia device

Interventions

Bilateral ESP BlockPROCEDURE

Bilateral ESP Block will be performed at T8

Bilateral
Unilateral ESP BlockPROCEDURE

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

Unilateral
Intravenous Morphine patient controlled analgesia deviceDEVICE

24 hour morphine consumption will be recorded

BilateralUnilateral

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Hospital

İzmit, Kocaeli, 41340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeCholecystitisGallstones

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsGallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisCholecystolithiasisCalculiPathological Conditions, Anatomical

Study Officials

  • Can Aksu

    Kocaeli Üniversitesi Tıp Fakültesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 18, 2018

First Posted

December 20, 2018

Study Start

January 2, 2019

Primary Completion

June 28, 2019

Study Completion

June 29, 2019

Last Updated

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)