Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03769818
Recruitment Status : Completed
First Posted : December 10, 2018
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 10, 2018
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE January 1, 2019
Actual Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
Visual analog score for pain during movement [ Time Frame: 24 hours post operative ]
movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Visual analog score for pain during rest [ Time Frame: 24 hours postoperative ]
    ranging from 0 to 10, where 0 no pain and 10 maximum pain
  • number of patients need Fentanyl consumption [ Time Frame: 24 hours postoperative ]
    calculation of the number of patients need Fentanyl consumption
  • number of days patients stay in hospital [ Time Frame: 4 weeks ]
    calculation of number of days patients stay in hospital
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy
Official Title  ICMJE Role of Adjuvant Dexamethasone for Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Double-blind Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A prospective Randomized Interventional double-blind study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Prevention
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: bupivacaine
    Bilateral TAP block with 20 ml of 0.25% bupivacaine
    Other Name: Active Comparator
  • Drug: dexamethasone
    Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.
    Other Name: active comparator
  • Drug: placebo to dexamethasone
    Bilateral TAP block with placebo to dexamethasone.
  • Drug: placebo to bupivacaine
    Bilateral TAP block with placebo to bupivacaine.
Study Arms  ICMJE
  • Active Comparator: bupivacaine and dexamethasone
    Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
    Interventions:
    • Drug: bupivacaine
    • Drug: dexamethasone
  • Active Comparator: bupivacaine and placebo to dexamethasone
    Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
    Interventions:
    • Drug: bupivacaine
    • Drug: placebo to dexamethasone
  • Placebo Comparator: control group
    Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone
    Interventions:
    • Drug: placebo to dexamethasone
    • Drug: placebo to bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2020
Actual Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: patients undergoing total abdominal hysterectomy
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03769818
Other Study ID Numbers  ICMJE aswu/181/18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party hany farouk, Aswan University Hospital
Study Sponsor  ICMJE Aswan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: hany f sallam, md Aswan University Hospital
PRS Account Aswan University Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP