NCT04176770

Brief Summary

This study aim to compare the efficiency and the analgesic effect of Erector Spinal Plane Block versus TAP Block after laparoscopic cholecystectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

November 22, 2019

Last Update Submit

November 26, 2019

Conditions

Post Operative Pain

Keywords

Laparoscopic cholecystectomyPost OperativeAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Post Operative analgesia

    Post operative analgesia assessed with Numerical rating scale (0=minimum, 10= Maximum)

    24 hours after intervention

Secondary Outcomes (1)

  • post operative analgesic consumption

    24 hours after intervention

Study Arms (2)

ESP group

EXPERIMENTAL

ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.

Procedure: ESP Block

TAP Block

EXPERIMENTAL

TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%

Procedure: TAP Block

Interventions

ESP BlockPROCEDURE

ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.

ESP group
TAP BlockPROCEDURE

TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%

TAP Block

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • ASA status I or II
  • scheduled for laparoscopic cholecystectomy

You may not qualify if:

  • laparotomy
  • unplanned ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi Slim Hospital

Tunis, 2046, Tunisia

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Mhamed Sami Mebazaa, Professor

    Mongi Slim Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mhamed Sami Mebazaa, professor

CONTACT

0021622252589msmebazaa@gmail.com

Asma Ben Souissi, Ass Prof

CONTACT

0021698336883bsouissiasma@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, head of the anesthesia and ICU departement

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 25, 2019

Study Start

December 1, 2019

Primary Completion

May 30, 2020

Study Completion

June 30, 2020

Last Updated

November 29, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)