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Erector Spinae vs TAP in Lower Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT04555993
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Shaban Mohammed, National Cancer Institute, Egypt

Brief Summary:
The aim of this study is to compare the analgesic effect and safety profile of erector spinae plane block with transverses abdominis plane block in controlling peri-operative pain for lower abdominal cancer surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: lower abdominal surgery Other: Erector spinae plane block Other: Transversus abdominis plane block Not Applicable

Detailed Description:

Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep breathing disorders. Therefore strategies other than opioids are recommended without sacrificing proper and effective analgesia. Especially in cancer patients who are more susceptible to tolerance and addiction.

The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used effectively in laparotomies. Unilateral analgesia to the skin, muscles, and parietal peritoneum of the anterior abdominal wall will be achieved without affecting visceral pain, when the anterior rami of the lower six thoracic nerves (T7-T12) and the first lumbar nerve (L1) are blocked.

Erector spinae plane block (ESPB) was shown to be an effective analgesic option for different types of surgeries. It's relatively a simple block, drug is injected in the plane between the erector spinae muscle and the vertebral transverse process. Blocking the ventral and dorsal rami of spinal nerves on the paravertebral area distributed from T2-T4 to L1-L2 and gives good coverage to visceral pain. Owing to the lower risk of blood vessel damage and neural damage compared to the epidural or the paravertebral block.

Both blocks haven't been compared to each other in this type of surgery before.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Ultrasound-Guided Transversus Abdominis Plane Block and Ultrasound-Guided Erector Spinae Plane Block in Postoperative Analgesia for Lower Abdominal Cancer Surgery. Randomised Double Blinded Control Study
Actual Study Start Date : February 28, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 15, 2020

Arm Intervention/treatment
Active Comparator: Transversus abdomis plane block
Patients will receive Transversus abdomis plane block
Procedure: lower abdominal surgery
Patients will undergo lower abdominal surgery under general anesthesia.

Other: Transversus abdominis plane block
patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).

Experimental: Erector spinae plane block
Patients will receive Erector spinae plane block.
Procedure: lower abdominal surgery
Patients will undergo lower abdominal surgery under general anesthesia.

Other: Erector spinae plane block
patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).




Primary Outcome Measures :
  1. Total morphine consumption [ Time Frame: 24 hours ]
    The total amount of morphine which was consumed post-operatively measured in milligrams


Secondary Outcome Measures :
  1. Intraoperative fentanyl consumption. [ Time Frame: intraoperative ]
    The total amount of fentanyl which was consumed during the surgery measured in milligrams


Other Outcome Measures:
  1. Postoperative nausea and vomiting [ Time Frame: 24 hours postoperative ]
    the number of patients who had nausea and vomiting

  2. Time for first rescue analgesia. [ Time Frame: 24 hours postoperative ]
    the time at which the patient will request an analgesic

  3. Heart rate [ Time Frame: 24 hours ]
    the number of heart beats in one minute

  4. Numerical rating scale for pain assessment. [ Time Frame: 24 hours ]
    This is a numerical rating scale for pain assessment which ranges from 0 to 10 with the least pain at scale 0 and the worst pain at scale 10

  5. mean arterial blood pressure [ Time Frame: 24 hours ]
    the mean arteiral blood pressure measurend in mmHg



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physical status ASA II.
  • Age ≥ 18 and ≤ 65 Years.
  • Cancer patients undergoing laparotomies for radical cystectomy or radical hysterectomy or low anterior resection (lower abdominal procedures).
  • Patient is able to provide a written informed consent.
  • Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.

Exclusion Criteria:

  • Age <18 years or >65 years.
  • BMI <20 kg/m2 and >40 kg/m2.
  • Known sensitivity to local anaesthetics and morphine.
  • History of psychological disorders and/or chronic pain.
  • Significant liver or renal insufficiency.
  • Contraindication to regional anaesthesia e.g. local sepsis, preexisting peripheral neuropathies and coagulopathy.
  • Patient refusal.
  • Severe respiratory or cardiac disorders.
  • Pregnancy.
  • ASA III-IV.

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): NCT04555993


Contacts
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Contact: ahmed hasanin, Professor +201095076954 ahmedmohamedhasanin@gmail.com
Contact: ahmed zaghloul, Professor 00201001839591 a_zaghloul2000@yahoo.com

Locations
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Egypt
National Cancer Institute Recruiting
Cairo, Egypt
Sponsors and Collaborators
National Cancer Institute, Egypt
Investigators
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Study Chair: waleed hamimy, Professor Cairo University
Publications:
Yarwood J, Berrill A (2010). Nerve blocks of the anterior abdominal wall, Continuing Education in Anaesthesia Critical Care & Pain, Vol10, Issue 6, pp 182-186.

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Responsible Party: Ahmed Shaban Mohammed, Assistant lecturer of anesthesia and critical care medicine, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier: NCT04555993    
Other Study ID Numbers: MS-39-2019
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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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 Ahmed Shaban Mohammed, National Cancer Institute, Egypt:
erector spinae block
TAP Block
abdominal surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations