Erector Spinae vs TAP in Lower Abdominal Surgery

September 15, 2020 updated by: Ahmed Shaban Mohammed, National Cancer Institute, Egypt

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption
Time Frame: 24 hours
The total amount of morphine which was consumed post-operatively measured in milligrams
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative fentanyl consumption.
Time Frame: intraoperative
The total amount of fentanyl which was consumed during the surgery measured in milligrams
intraoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting
Time Frame: 24 hours postoperative
the number of patients who had nausea and vomiting
24 hours postoperative
Time for first rescue analgesia.
Time Frame: 24 hours postoperative
the time at which the patient will request an analgesic
24 hours postoperative
Heart rate
Time Frame: 24 hours
the number of heart beats in one minute
24 hours
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
24 hours
mean arterial blood pressure
Time Frame: 24 hours
the mean arteiral blood pressure measurend in mmHg
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Investigators

  • Study Chair: waleed hamimy, Professor, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 15, 2020

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-39-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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