NCT03420703

Brief Summary

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented application of this blockade into practice at the clinic. Main purpose of this study is to evaluate the analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

February 24, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

2 months

First QC Date

January 29, 2018

Last Update Submit

June 13, 2018

Conditions

Postoperative Pain

Keywords

erector spinae plane blocklaparoscopic cholecystectomypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • 24h morphine consumption

    morphine consumptions for both group will be recorded

    for postoperative 24 hour

Secondary Outcomes (2)

  • Postoperative nausea and vomiting

    24 hour

  • Pain

    24h

Study Arms (2)

Block group

ACTIVE COMPARATOR

Erector espine plane block will be administrated to this group. An intravenous patient controlled analgesia device will be given to the patients postoperatively

Other: erector spinae plane blockDevice: Intravenous morphine patient controlled analgesia device

control group

SHAM COMPARATOR

An intravenous patient controlled analgesia device will be given to the patients postoperatively

Device: Intravenous morphine patient controlled analgesia device

Interventions

erector spinae plane blockOTHER

ultrasound guided erector spinae plane block will be administered to this group.

Block group
Intravenous morphine patient controlled analgesia deviceDEVICE

Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded

Block groupcontrol group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • ASA I - II
  • Undergoing elective laparoscopic cholecystectomy

You may not qualify if:

  • obesity
  • ASA III - IV
  • 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, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 5, 2018

Study Start

February 24, 2018

Primary Completion

April 18, 2018

Study Completion

April 18, 2018

Last Updated

June 15, 2018

Record last verified: 2018-06

Locations

TU(1)