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Clinical Trials/NCT04555993
NCT04555993
Unknown
Not Applicable

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

National Cancer Institute, Egypt1 site in 1 country62 target enrollmentFebruary 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
National Cancer Institute, Egypt
Enrollment
62
Locations
1
Primary Endpoint
Total morphine consumption
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2020
End Date
October 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Cancer Institute, Egypt
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Shaban Mohammed

Assistant lecturer of anesthesia and critical care medicine

National Cancer Institute, Egypt

Eligibility 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/m
  • 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.

Outcomes

Primary Outcomes

Total morphine consumption

Time Frame: 24 hours

The total amount of morphine which was consumed post-operatively measured in milligrams

Secondary Outcomes

  • Intraoperative fentanyl consumption.(intraoperative)

Study Sites (1)

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