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Erector Spinae vs TAP in Lower Abdominal Surgery

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lower abdominal surgery
Erector spinae plane block
Transversus abdominis plane block
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring erector spinae block, TAP Block, abdominal surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Transversus abdomis plane block

Erector spinae plane block

Arm Description

Patients will receive Transversus abdomis plane block

Patients will receive Erector spinae plane block.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intraoperative fentanyl consumption.
The total amount of fentanyl which was consumed during the surgery measured in milligrams

Full Information

First Posted
September 1, 2020
Last Updated
September 15, 2020
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04555993
Brief Title
Erector Spinae vs TAP in Lower Abdominal Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
erector spinae block, TAP Block, abdominal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transversus abdomis plane block
Arm Type
Active Comparator
Arm Description
Patients will receive Transversus abdomis plane block
Arm Title
Erector spinae plane block
Arm Type
Experimental
Arm Description
Patients will receive Erector spinae plane block.
Intervention Type
Procedure
Intervention Name(s)
lower abdominal surgery
Intervention Description
Patients will undergo lower abdominal surgery under general anesthesia.
Intervention Type
Other
Intervention Name(s)
Erector spinae plane block
Intervention Description
patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).
Intervention Type
Other
Intervention Name(s)
Transversus abdominis plane block
Intervention Description
patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
The total amount of morphine which was consumed post-operatively measured in milligrams
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Intraoperative fentanyl consumption.
Description
The total amount of fentanyl which was consumed during the surgery measured in milligrams
Time Frame
intraoperative
Other Pre-specified Outcome Measures:
Title
Postoperative nausea and vomiting
Description
the number of patients who had nausea and vomiting
Time Frame
24 hours postoperative
Title
Time for first rescue analgesia.
Description
the time at which the patient will request an analgesic
Time Frame
24 hours postoperative
Title
Heart rate
Description
the number of heart beats in one minute
Time Frame
24 hours
Title
Numerical rating scale for pain assessment.
Description
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
Time Frame
24 hours
Title
mean arterial blood pressure
Description
the mean arteiral blood pressure measurend in mmHg
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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/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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed hasanin, Professor
Phone
+201095076954
Email
ahmedmohamedhasanin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed zaghloul, Professor
Phone
00201001839591
Email
a_zaghloul2000@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
waleed hamimy, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
23066371
Citation
Randerath WJ, George S. Opioid-induced sleep apnea: is it a real problem? J Clin Sleep Med. 2012 Oct 15;8(5):577-8. doi: 10.5664/jcsm.2162. No abstract available.
Results Reference
background
PubMed Identifier
20377549
Citation
Finnerty O, Carney J, McDonnell JG. Trunk blocks for abdominal surgery. Anaesthesia. 2010 Apr;65 Suppl 1:76-83. doi: 10.1111/j.1365-2044.2009.06203.x.
Results Reference
background
PubMed Identifier
18227342
Citation
Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
20216023
Citation
Abrahams MS, Horn JL, Noles LM, Aziz MF. Evidence-based medicine: ultrasound guidance for truncal blocks. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S36-42. doi: 10.1097/AAP.0b013e3181d32841.
Results Reference
background
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
PubMed Identifier
28188621
Citation
Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
Results Reference
background
PubMed Identifier
28252539
Citation
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.
Results Reference
background
PubMed Identifier
29991225
Citation
De Cassai A, Marchet A, Ori C. The combination of erector spinae plane block and pectoralis blocks could avoid general anesthesia for radical mastectomy in high risk patients. Minerva Anestesiol. 2018 Dec;84(12):1420-1421. doi: 10.23736/S0375-9393.18.13031-8. Epub 2018 Jul 9. No abstract available.
Results Reference
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Erector Spinae vs TAP in Lower Abdominal Surgery

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