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Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bupivacaine
dexamethasone
placebo to dexamethasone
placebo to bupivacaine
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring erector spinae plane block, total abdominal hysterectomy, dexamethasone

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Aswan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

bupivacaine and dexamethasone

bupivacaine and placebo to dexamethasone

control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Visual analog score for pain during movement
movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain

Secondary Outcome Measures

Visual analog score for pain during rest
ranging from 0 to 10, where 0 no pain and 10 maximum pain
number of patients need Fentanyl consumption
calculation of the number of patients need Fentanyl consumption
number of days patients stay in hospital
calculation of number of days patients stay in hospital

Full Information

First Posted
December 6, 2018
Last Updated
August 3, 2020
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03769818
Brief Title
Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy
Official Title
Role of Adjuvant Dexamethasone for Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Double-blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Optimal dynamic analgesia is recognized as the key to enhanced recovery following open abdominal surgery. In the last decade, there has been a significant shift away from thoracic epidural analgesia (TEA) that has been long considered as the gold standard. Various techniques have tried to replicate the analgesic efficacy of TEA. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and trans muscular quadratus lumborum analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries. Chin et al first described the erector spinae plane (ESP) block for providing analgesia following ventral hernia repair. The unique feature of the ultrasound-guided truncal blocks is that in all of these techniques, in contrast to peripheral nerve blocks, no nerve or plexus needs to be identified: Local anesthesia (LA) is injected in a particular muscle plane, in which the injectate spreads and reaches the intended nerves. This simple mechanism has made delivery of nerve blocks easy and versatile.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
erector spinae plane block, total abdominal hysterectomy, dexamethasone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective Randomized Interventional double-blind study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bupivacaine and dexamethasone
Arm Type
Active Comparator
Arm Description
Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
Arm Title
bupivacaine and placebo to dexamethasone
Arm Type
Active Comparator
Arm Description
Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Other Intervention Name(s)
Active Comparator
Intervention Description
Bilateral TAP block with 20 ml of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
active comparator
Intervention Description
Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.
Intervention Type
Drug
Intervention Name(s)
placebo to dexamethasone
Intervention Description
Bilateral TAP block with placebo to dexamethasone.
Intervention Type
Drug
Intervention Name(s)
placebo to bupivacaine
Intervention Description
Bilateral TAP block with placebo to bupivacaine.
Primary Outcome Measure Information:
Title
Visual analog score for pain during movement
Description
movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
24 hours post operative
Secondary Outcome Measure Information:
Title
Visual analog score for pain during rest
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
24 hours postoperative
Title
number of patients need Fentanyl consumption
Description
calculation of the number of patients need Fentanyl consumption
Time Frame
24 hours postoperative
Title
number of days patients stay in hospital
Description
calculation of number of days patients stay in hospital
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
patients undergoing total abdominal hysterectomy
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ranging age between 30-60 years a who undergoing elective total abdominal hysterectomy Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University
City
Aswan
ZIP/Postal Code
81528
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy

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