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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

Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE June 13, 2019
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • "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"
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Side effects [ Time Frame: Up to 24 hours postoperative. ]
    Side effects as: Nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
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).
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 Bilateral Ultrasound Guided ESP Block Versus TAP Block on Post-operative Analgesia After Total Abdominal Hysterectomy
Official Title  ICMJE Bilateral Ultrasound Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-operative Analgesia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Erector Spinae Plane Block
    Bilateral Ultrasound Guided Erector Spinae Plane Block
    Intervention: Procedure: 1) Ultrasound guided Erector spinae block
  • Active Comparator: transversus abdominis plane block
    Ultrasound guided transversus abdominis plane block
    Intervention: Procedure: Ultrasound guided transversus abdominis plane block
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: May 24, 2019)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 11, 2019
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT03965156
Other Study ID Numbers  ICMJE 5423
Has Data Monitoring Committee Not Provided
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: No
Responsible Party Alshaimaa Abdel Fattah Kamel, Zagazig University
Study Sponsor  ICMJE Zagazig University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alshaimaa Kamel, M.D faculty of medicine ,zagazig universty
PRS Account Zagazig University
Verification Date October 2019

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