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Erector Spinae Plane Block For Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy (Erector Spinae)

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ClinicalTrials.gov Identifier: NCT03741348
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed hamed, Fayoum University

Brief Summary:
The aim of this study was to assess the efficacy of bilateral ESPB on postoperative analgesia in patients undergoing total abdominal hysterectomy under general anesthesia.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Erector Spinae Plane Block Procedure: control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Erector Spinae Plane Block For Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Study
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : September 15, 2018
Actual Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ES
Erector Spinae Plane Block
Procedure: Erector Spinae Plane Block
In (ES) group After skin sterilization, ESPB was performed in sitting position at the level of T9 linear ultrasound (US) transducer (Phillips-Saronno Italy) was placed vertically 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between the two transverse processes. After local infiltration of needle insertion site with 2-3ml of 2% lidocaine, a 22‑gauge Short bevel needle (Spinocan, B.Braun Melsungen AG, Germany) was inserted in cranial-caudal direction towards transverse process (TP) in-plane to the US transducer until needle touched the TP crossing all the muscles. Then, up to 20 ml of bupivacaine 0.5% was injected. The procedure was repeated following the same steps on the other side of back.

Placebo Comparator: control
the control group will not receive block
Procedure: control
in control group, Erector Spinae Plane Block will not be done




Primary Outcome Measures :
  1. Fentanyl consumption [ Time Frame: first 24 hours postoperative ]
    in microgram


Secondary Outcome Measures :
  1. Visual analog score [ Time Frame: 30 minutes postoperative ]
    ranging from 0 to 10, where 0 no pain and 10 maximum pain

  2. Visual analog score [ Time Frame: 2 hours postoperative ]
    ranging from 0 to 10, where 0 no pain and 10 maximum pain

  3. Visual analog score [ Time Frame: 4 hours postoperative ]
    ranging from 0 to 10, where 0 no pain and 10 maximum pain

  4. Visual analog score [ Time Frame: 6 hours postoperative ]
    ranging from 0 to 10, where 0 no pain and 10 maximum pain

  5. Visual analog score [ Time Frame: 12 hours postoperative ]
    ranging from 0 to 10, where 0 no pain and 10 maximum pain

  6. Visual analog score [ Time Frame: 24 hours postoperative ]
    ranging from 0 to 10, where 0 no pain and 10 maximum pain


Other Outcome Measures:
  1. Age [ Time Frame: 4 hours before operation once recruited ]
    in years

  2. Weight [ Time Frame: 4 hours before operation once recruited ]
    in Kilogram

  3. Duration of surgery [ Time Frame: 4 minutes after end of operation ]
    in minutes



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female patients
  • Aged 40 - 70 years,
  • Weighted 50 - 90 Kg
  • American society of Anesthesiologists physical status (ASA) class Ι to ΙΙΙ
  • Scheduled for elective total abdominal hysterectomy under general anesthesia

Exclusion Criteria:

  • Local infection at the site of puncture
  • Patients having a history of hematological disorders, including coagulation abnormality
  • Patients with severe hepatic impairment
  • Patients with chronic pain
  • A patient had a known allergy to study drugs.

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): NCT03741348


Locations
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Egypt
Mohamed
Fayoum, Egypt, 65345
Sponsors and Collaborators
Fayoum University
Investigators
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Principal Investigator: mohamed a hamed, MD Fayoum University

Publications:
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Responsible Party: Mohamed hamed, lecturer of anesthesia, Fayoum University
ClinicalTrials.gov Identifier: NCT03741348     History of Changes
Other Study ID Numbers: R124
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mohamed hamed, Fayoum University:
Erector Spinae Plane Block
Postoperative Analgesia
Total Abdominal Hysterectomy
fentanyl consumption

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms