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Comparison of Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Rectus Sheath Block in Adults Undergoing Major Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT04229420
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital

Brief Summary:
This randomized, controlled study is designed to assess the quality of analgesia provided by ultrasound guided ESPB versus RSB in adults undergoing major abdominal surgery.

Condition or disease Intervention/treatment Phase
Pain Postoperative Device: Ultrasound guided Rectus sheath block vs Erector spinae plane block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Study will be conducted on 60 adults aged from 18 to 60 years presented for major abdominal surgeries (open colorectal resections or major ventral hernia repair) at general surgery operating theatres, Cairo university hospitals.

Patients will be divided into two equal groups; rectus sheath block group RSB (n=30) and erector spinae plane block group ESPB (n=30).

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Rectus Sheath Block in Adults Undergoing Major Abdominal Surgery: a Randomized Comparative Study.
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Rectus sheath block group (RSB)
After preparing the skin, a high frequency (5-10 MHz) ultrasound probe will be placed in a longitudinal orientation above the level of the umbilicus with the Patient in the supine position. After identifying the rectus abdominis muscle, A 22 G echogenic needle using the in plane technique will be inserted just below the costal margin then, a total of 20 ml of 0.25% bupivacaine will be injected into the plane between the rectus muscle and posterior rectus sheath. Negative aspiration will be confirmed every 5 ml. The block will then be repeated on the other side.
Device: Ultrasound guided Rectus sheath block vs Erector spinae plane block
Ultrasound guided Rectus sheath block vs Erector spinae plane block

Active Comparator: Erector spinae plane block group (ESPB)
After induction of anesthesia; the patient will be positioned on the lateral position. The skin will be prepared with povidone iodine, and a high frequency (5-10 MHz) ultrasound probewill be placed in a transverse orientation on the T9 spinous process which will be located by palpating and counting down from the C7 spinous process. The tip of the T9 transverse process will be identified and centred on the ultrasound screen, the probe will then be rotated into a longitudinal orientation to produce a parasagittal view. Correct location of the needle tip in the fascial plane deep to erector spinae muscle is confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total of 20 ml of 0.25% bupivacaine will then be injected into the ESP of both sides.
Device: Ultrasound guided Rectus sheath block vs Erector spinae plane block
Ultrasound guided Rectus sheath block vs Erector spinae plane block




Primary Outcome Measures :
  1. Time to first request of postoperative rescue analgesics [ Time Frame: 24 hours ]
    the time interval between the block performance and the first request to postoperative analgesia and or VAS ≥ 4


Secondary Outcome Measures :
  1. Visual analogue score at rest (static), and on movement or coughing (dynamic) [ Time Frame: 24 hours ]

    Visual analogue score at rest (static), and on movement or coughing (dynamic) at 30 and 60 minutes in the PACU then every 6 hours in the ward for 24 hours.

    The visual analogue score is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length.

    For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100‐mm scale])


  2. Total consumption of morphine [ Time Frame: 24 hours ]
    total postoperative morphine consumption

  3. Incidence of perioperative complications. [ Time Frame: 24 hours ]
    Incidence of perioperative complications(lower limb weakness, hematoma, viscus injury, intravascular injection and PONV

  4. Block performance time in min [ Time Frame: procedure (time from probe contact with skin till needle withdrawal) ]
    time from probe contact with skin till needle withdrawal.

  5. Failure rate of the block [ Time Frame: 1st postoperative hour ]
    will be calculated, where the block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-II. Age: 18 to 60 years. Undergoing midline vertical laparotomy incisions (open colorectal resections or major ventral hernia repair).

Exclusion Criteria:

  1. Refusal of patients.
  2. Patients with coagulation disorders (Platelets ≤ 50,000 and/or INR> 1.5).
  3. History of allergic reactions to local anesthetics.
  4. Rash or signs of infection at the injection site.
  5. Emergency surgery.

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): NCT04229420


Contacts
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Contact: Khaled A Sarhan, MD +201020067816 khaled.sarhan@kasralainy.edu.eg
Contact: khaled sarhan, MD +201020067816 khaled.sarhan@kasralainy.edu.eg

Locations
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Egypt
Kasralainy Recruiting
Cairo, Egypt, 11559
Contact: Khaled Sarhan, MD    +201020067816    khaled.sarhan@kasralainy.edu.eg   
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Khaled Sarhan, MD Lecturer of anesthesia, Cairo university

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Responsible Party: Khaled Abdelfattah Abdallah Sarhan, principal investigator, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT04229420    
Other Study ID Numbers: MD-33-2019
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
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 Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital:
erector spinae
ultrasound
rectus sheath
pain