NCT03751540

Brief Summary

the investigators use usually a plane block for postoperative analgesia; if it suitable. İn laparoscopic patients; investigators used oblique subcostal transversus abdominis plane block; formerly. But in the last few months, the investigators have performed serratus intercostal (BRILMA) block with bilateral rectus sheath block. in this retrospective evaluation, the aim of the retrospective evaluation is to determine the effects of two block on postoperative opioid consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

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

Study Start

First participant enrolled

May 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

November 19, 2018

Last Update Submit

November 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using

    24 hours

Secondary Outcomes (1)

  • Pain assessed by NRS

    24 hours

Study Arms (2)

OSTAP

Data of patients (performed oblique subcostal transversus abdominis plane-OSTAP- block for postoperative analgesia in laparoscopic cholecystectomy) will be collected.

Procedure: ostap

SIPB plus rectus sheath block

Data of patients (performed serratus intercostal plane block-SIPB- plus rectus sheath block for postoperative analgesia in laparoscopic cholecystectomy) will be collected.

Procedure: SIPB plus rectus sheath block

Interventions

ostapPROCEDURE

this block is performed under general anesthesia in this patients for postoperative analgesia.

OSTAP

this block is performed under general anesthesia in this patients for postoperative analgesia.

SIPB plus rectus sheath block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients undergoing laparoscopic cholecystectomy, ASA I-II-III patients.

You may qualify if:

  • patients undergoed laparoscopic cholecystectomy ASA I-II-III

You may not qualify if:

  • patients used another block or block combination
  • no block performed patients
  • procedure converted to open procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University faculty of medicine

Istanbul, 34090, Turkey (Türkiye)

Location

Related Publications (2)

  • Chen Y, Shi K, Xia Y, Zhang X, Papadimos TJ, Xu X, Wang Q. Sensory Assessment and Regression Rate of Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Volunteers. Reg Anesth Pain Med. 2018 Feb;43(2):174-179. doi: 10.1097/AAP.0000000000000715.

    PMID: 29278604BACKGROUND
  • Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.

    PMID: 29789137BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • serkan tulgar

    Maltepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated professor

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 23, 2018

Study Start

May 1, 2018

Primary Completion

November 1, 2018

Study Completion

November 26, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations