NCT05633329

Brief Summary

To evaluate and compare the efficacy of single level injection erector spinae plane block versus double level injection Erector spinae plane block in laparotomies

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

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

November 4, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

December 7, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

November 4, 2022

Last Update Submit

June 17, 2023

Conditions

Post Operative PainRegional Block

Keywords

ESPBpainregional block

Outcome Measures

Primary Outcomes (1)

  • first analgesic request

    time to request fentanyl

    24 hours

Secondary Outcomes (3)

  • resting visual analogue pain scale

    24 hours

  • dynamic visual analogue pain scale

    24 hours

  • analgesic consumption

    24 hours

Study Arms (2)

single ESPB

EXPERIMENTAL

single injection at level T8

Procedure: single level

dual ESB

EXPERIMENTAL

dual injection at level T7 and T9

Procedure: dual level

Interventions

single levelPROCEDURE

injection of 40 ml bupivacaine 0.25 at T8 (20 ml on each side)

single ESPB
dual levelPROCEDURE

injection of 40 ml of bupivacaine 0.25 at two level T7 and T9 (10 ml on each level of both side)

dual ESB

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age18-60.
  • Both genders.
  • abdominal surgery.
  • ASA I-III.

You may not qualify if:

  • Drug allergy.
  • Morbid obesity (BMI \>40 kg/m2).
  • Psychiatric disorder.
  • Opiod dependence.
  • patient refuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Minya Governorate, 61511, Egypt

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Floors and Floorcoverings

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Facility Design and ConstructionArchitectureTechnology, Industry, and Agriculture

Study Officials

  • hassan m. hetta, lecturer

    Minia University, faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and ICU

Study Record Dates

First Submitted

November 4, 2022

First Posted

December 1, 2022

Study Start

December 7, 2022

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)