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

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ClinicalTrials.gov Identifier: NCT03769818
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: bupivacaine Drug: dexamethasone Drug: placebo to dexamethasone Drug: placebo to bupivacaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: bupivacaine and dexamethasone
Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
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

Active Comparator: bupivacaine and placebo to dexamethasone
Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
Drug: bupivacaine
Bilateral TAP block with 20 ml of 0.25% bupivacaine
Other Name: Active Comparator

Drug: placebo to dexamethasone
Bilateral TAP block with placebo to dexamethasone.

Placebo Comparator: control group
Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone
Drug: placebo to dexamethasone
Bilateral TAP block with placebo to dexamethasone.

Drug: placebo to bupivacaine
Bilateral TAP block with placebo to bupivacaine.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. number of patients need Fentanyl consumption [ Time Frame: 24 hours postoperative ]
    calculation of the number of patients need Fentanyl consumption

  3. number of days patients stay in hospital [ Time Frame: 4 weeks ]
    calculation of number of days patients stay in hospital



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   patients undergoing total abdominal hysterectomy
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769818


Contacts
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Contact: hany f sallam 01022336052 ext 002 hany.farouk@aswu.edu.eg

Locations
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Egypt
Aswan University Recruiting
Aswan, Egypt, 81528
Contact: hany f sallam, md    01092440504 ext 002    nahla.elsayed@aswu.ed.eg   
Contact: Nahla w Shady, md    1019240504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f sallam, md Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03769818     History of Changes
Other Study ID Numbers: aswu/181/18
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hany farouk, Aswan University Hospital:
erector spinae plane block
total abdominal hysterectomy
dexamethasone

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents