NCT05277974

Brief Summary

Thoracotomy is a very painful procedure. Different treatment modalities are being utilized for post-thoracotomy analgesia including I/V NSAID, Opoids and Neuropathic medications. Other techniques commonly utilized include Thoracic epidural, Paravertebral block; but both are associated with significant failure rate and other complications. Ultrasound guided Erector Spinae Plane block is a new regional anesthesia technique that provides analgesia at multidermatomal levels acriss the posterior, lateral and anterior thoracic walls. The rational of my study is that it is a novel technique and studies with bupivicain alone are present but no study was found with bupivicain plus dexamethasone.

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
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

February 15, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

March 3, 2022

Last Update Submit

March 3, 2022

Conditions

Keywords

Erector Spinae Plane Block, Thoracotomy, Ultrasound

Outcome Measures

Primary Outcomes (1)

  • postoperative pain scores

    Visual Analogue Score is utilized to assess the postoperative pain

    36 hours postoperatively

Study Arms (2)

Group B.

ACTIVE COMPARATOR

group B will receive Inj Bupivicain only in Erector Spinae Plane Block.

Drug: inj bupivicain

Group D

ACTIVE COMPARATOR

group D will receive Inj Bupivicain plus Dexamethasone in Erector Spinae Plane Block.

Drug: inj bupivicain

Interventions

In goup B 30ml of inj. bupivicaine only will be given in Erector Spinae Plane Block and In Group D inj Bupivicain plus inj dexamethasone will be given

Also known as: inj bupivicain plus dexamethasone
Group B.Group D

Eligibility Criteria

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

You may qualify if:

  • age 18-60years ASA I-III Patients undergoing elective thoracotomies

You may not qualify if:

  • Refusal of Patient Coagulation disorders Known Allergy to Local Anesthetics Infection at the site of injection Pregnant females Morbid Obesity(BMI\>40kg/m2) Psychiatric illness Diabetic Patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheikh Zayed Medical College/Hospital Rahim Yar Khan

Rahim Yar Khan, Punjab Province, 64200, Pakistan

RECRUITING

Sheikh Zayed Medical College/Hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • amjad siddique, FCPS

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

amjad siddique, FCPS

CONTACT

saira sadaf, FCPS

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 14, 2022

Study Start

February 15, 2022

Primary Completion

June 15, 2022

Study Completion

July 10, 2022

Last Updated

March 14, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations