NCT03769818

Brief Summary

The aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone for erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy Group 1: bupivacaine 0.25% + dexamethasone 8 mg

  • Group 2: bupivacaine 0.25%
  • Group3: control group A prospective Randomized Interventional double-blind study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable postoperative-pain

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

First Submitted

Initial submission to the registry

December 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

December 6, 2018

Last Update Submit

August 3, 2020

Conditions

Postoperative Pain

Keywords

erector spinae plane blocktotal abdominal hysterectomydexamethasone

Outcome Measures

Primary Outcomes (1)

  • Visual analog score for pain during movement

    movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain

    24 hours post operative

Secondary Outcomes (3)

  • Visual analog score for pain during rest

    24 hours postoperative

  • number of patients need Fentanyl consumption

    24 hours postoperative

  • number of days patients stay in hospital

    4 weeks

Study Arms (3)

bupivacaine and dexamethasone

ACTIVE COMPARATOR

Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.

Drug: bupivacaineDrug: dexamethasone

bupivacaine and placebo to dexamethasone

ACTIVE COMPARATOR

Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone

Drug: bupivacaineDrug: placebo to dexamethasone

control group

PLACEBO COMPARATOR

Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone

Drug: placebo to dexamethasoneDrug: placebo to bupivacaine

Interventions

bupivacaineDRUG

Bilateral TAP block with 20 ml of 0.25% bupivacaine

Also known as: Active Comparator
bupivacaine and dexamethasonebupivacaine and placebo to dexamethasone
dexamethasoneDRUG

Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.

Also known as: active comparator
bupivacaine and dexamethasone
placebo to dexamethasoneDRUG

Bilateral TAP block with placebo to dexamethasone.

bupivacaine and placebo to dexamethasonecontrol group
placebo to bupivacaineDRUG

Bilateral TAP block with placebo to bupivacaine.

control group

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatients undergoing total abdominal hysterectomy
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women ranging age between 30-60 years a who undergoing elective total abdominal hysterectomy

You may not qualify if:

  • Participants had known sensitivity to bupivacaine
  • Participants had difficulty in intubation
  • Participants were on chronic pain medication or already on long-term opioids
  • Participants smokers
  • Participants with disabilities who were unable to communicate pain levels
  • refuse to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineDexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • hany f sallam, md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete for group 1 and 2.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A prospective Randomized Interventional double-blind study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 10, 2018

Study Start

January 1, 2019

Primary Completion

March 30, 2020

Study Completion

August 1, 2020

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

EG(1)