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Bilateral Ultrasound Guided ESP Block Versus TAP Block on Post-operative Analgesia After Total Abdominal Hysterectomy

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ClinicalTrials.gov Identifier: NCT03965156
Recruitment Status : Completed
First Posted : May 28, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Alshaimaa Abdel Fattah Kamel, Zagazig University

Brief Summary:
  • Abdominal hysterectomy is an open surgical procedure associated with considerable post-operative pain. Narcotics are often required during patient recovery but can result in adverse side effects. Transversus abdominis plane block(TAP block) is a regional anesthetic technique that is found to be effective as post-operative analgesia after total abdominal hysterectomy. Recently, erector spinae plane block(ESP)block is found to be safe, and simple regional anesthetic technique that decrease total opioid consumption in patient undergoing breast, or abdominal surgery.
  • The aim is to compare the efficacy of bilateral erector spinae plane block, and bilateral transversus abdominis plane block on postoperative analgesia in patients after abdominal hysterectomy under general anesthesia, and their need for opioid.

Hypothesis

  • Null hypothesis (H0): No difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.
  • Alternative hypothesis (H1): There are difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.

Condition or disease Intervention/treatment Phase
Post-operative Analgesia Procedure: 1) Ultrasound guided Erector spinae block Procedure: Ultrasound guided transversus abdominis plane block Not Applicable

Detailed Description:

Sample size: Assuming that Mean±SD of reduced pain scores in erector spinae plane block is 4.7±3.7 versus 2.5±1 in transversus abdominis plane block.So, the total sample size is 48 cases (24 in each group) using Open Source Statistics for Public Health (open Epi) with confidence interval 95% and power of test is 80%.

d) Method of sample collection:

Forty eight female patients will be divided into two groups by a computer-generated randomization table:

Group (ES) (n=24): will receive bilateral ultrasound guided erector spinae plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) at the level of T9.

Group (TA) (n=24): will receive bilateral ultrasound guided transversus abdominis plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bilateral Ultrasound Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy
Actual Study Start Date : June 13, 2019
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Erector Spinae Plane Block
Bilateral Ultrasound Guided Erector Spinae Plane Block
Procedure: 1) Ultrasound guided Erector spinae block
In the lateral position, after skin sterilization, erector spinae plane block will be performed at the level of T9. Counting down from the spine of seventh cervical vertebrae, the spine of the nine thoracic vertebrae (T9). A linear low frequency ultrasound transducer (US) (3-5 MHz) will placed sagittal 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between transverse processes. A 22-gauge short bevel needle will be inserted in cranial-caudal direction towards transverse process (TP) in plane to the US transducer until needle touched the TP crossing all the muscles. The location of the needle tip will be confirmed by visible normal saline fluid separating erector spinae muscle off the bony shadow of the transverse process on ultrasound imaging. Then 20 ml of bupivacaine 0.375% plus plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side of the back.

Active Comparator: transversus abdominis plane block
Ultrasound guided transversus abdominis plane block
Procedure: Ultrasound guided transversus abdominis plane block
in supine position and after skin sterilization. The linear high frequency transducer (6-13 MHz) will be placed in the transverse plane to the the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The three abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) are visualized. The needle inserted in plane and advanced anterior to posterior under continual visualization until the tip between the internal oblique and the transversus abdominis muscle. After negative aspiration, a 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) will be injected. The success of the injection will be confirmed by separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in between. The procedure will be repeated following the same steps on the other side.




Primary Outcome Measures :
  1. The total amount of morphine given to each patient [ Time Frame: the first 24 hours postoperative. ]
    The total amount of morphine given to each patient during the first 24h of postoperative period

  2. The time to first call to analgesia (morphine) [ Time Frame: first call to morphine up to 24 hours postoperative. ]
    morphine (rescue analgesic) will be given if VAS>3.

  3. Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988). [ Time Frame: at 30 minutes postoperative. ]
    1- Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988). A commonly used visual analog scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. VAS score will be assessed at 30 minutes, 2hs, 4hs, 6hs, 12hs, and 24hs postoperative and IV increment of 3mg morphine (rescue analgesic) will be given if VAS>3.

  4. Pain intensity using Visual analogue Scale (VAS) [ Time Frame: at 2 hours postoperative. ]
    visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.

  5. Pain intensity using Visual analogue Scale (VAS) [ Time Frame: at 4 hours postoperative. ]
    visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.

  6. Pain intensity using Visual analogue Scale (VAS) [ Time Frame: at 6 hours postoperative. ]
    visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.

  7. Pain intensity using Visual analogue Scale (VAS) [ Time Frame: at 12 hours postoperative. ]
    visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.

  8. Pain intensity using Visual analogue Scale (VAS) [ Time Frame: at 24 hours postoperative. ]
    visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.

  9. "Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication" [ Time Frame: Up to 24 hours postoperative. ]
    "Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"


Secondary Outcome Measures :
  1. Over all patient satisfaction [ Time Frame: all over 24 hours postoperative ]
    Over all patient satisfaction:The patients will be asked to rate the overall degree of satisfaction of the analgesia using a 1-3 verbal scale (1 = unsatisfactory analgesia, 2 = satisfactory analgesia, and 3 = excellent analgesia) (Ross et al., 2009).



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female Patient.
  • Patient acceptance.
  • Age (40-60) years old.
  • American Society of Anaesthesiologist (ASA) I / II
  • Elective total abdominal hysterectomy under general anesthesia.
  • patient With Body Mass Index (BMI) (25-35kg/m²)

Exclusion Criteria:

  • Patient refusal.
  • Local infection at site of puncture.
  • Altered mental status.
  • History of allergy to study drugs ( bupivacaine, morphine).
  • Patients with chronic pain.
  • Patients with severe hepatic or kidney impairment.
  • Patients having a history of hematological disorders, including coagulation abnormality.

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): NCT03965156


Locations
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Egypt
Zagazig University Hospitsals
Zagazig, Egypt, 055
Sponsors and Collaborators
Zagazig University
Investigators
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Principal Investigator: Alshaimaa Kamel, M.D faculty of medicine ,zagazig universty
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Responsible Party: Alshaimaa Abdel Fattah Kamel, lecturer of Anaesthesia ,and surgical intensive care, Zagazig University
ClinicalTrials.gov Identifier: NCT03965156    
Other Study ID Numbers: 5423
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 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
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases