NCT03869801

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 the application of this blockade into practice at the clinic.Quadratus Lumborum block (QLB) type 2 is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and QLB in laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

3 active sites

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

March 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

March 8, 2019

Last Update Submit

May 31, 2019

Conditions

Postoperative PainAnesthesia, Local

Outcome Measures

Primary Outcomes (1)

  • analgesic consumption

    opioid consumption in Patient Controlled Analgesia device

    24 hours

Secondary Outcomes (1)

  • NRS scores

    24 hours

Study Arms (2)

ESP Block

ACTIVE COMPARATOR
Procedure: erector spinae plane block

QLB block

ACTIVE COMPARATOR
Procedure: quadratus lumborum block

Interventions

erector spinae plane blockPROCEDURE

Ultrasound-guided bilateral Erector spinae plane (ESP) block performed before the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.

Also known as: Standard Pain Followup and Monitorization
ESP Block
quadratus lumborum blockPROCEDURE

Ultrasound-guided bilateral Quadratus lumborum (QLB) type 2 block performed before the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.

Also known as: Standard Pain Followup and Monitorization
QLB block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective laparoscopic Cholecystectomy, ASA status 1-2

You may not qualify if:

  • Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding diathesis Use of any anti-coagulants Inability to provide informed consent Severe kidney or liver disease Inability to operate PCA system Patient with psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Antalya research hospital

Antalya, 07084, Turkey (Türkiye)

Location

Maltepe University faculty of medicine

Istanbul, 34090, Turkey (Türkiye)

Location

Cigli Educatinal Hospital

Izmir, 35085, Turkey (Türkiye)

Location

Related Publications (2)

  • Okmen K, Metin Okmen B, Topal S. Ultrasound-guided posterior quadratus lumborum block for postoperative pain after laparoscopic cholecystectomy: A randomized controlled double blind study. J Clin Anesth. 2018 Sep;49:112-117. doi: 10.1016/j.jclinane.2018.06.027. Epub 2018 Jun 18.

    PMID: 29929169RESULT

  • Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

    PMID: 29913392RESULT

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
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor in anesthesiology

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 11, 2019

Study Start

March 15, 2019

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

June 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(3)