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Transversus Abdominis Plane Block Versus Paravertebral Block for Post Operative Pain Relief in Open Renal Surgeries

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic paravertebral block
Transversus abdominis plane block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 18 - 60 years
  • ASA I-II class

Exclusion Criteria:

  • Patient refusal
  • Any contraindication of regional anesthesia block (Coagulopathy,infection at the needle insertion site)
  • Patients with allergy to amide local anesthetics or medication included in the study.

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group (P)

Group (T)

Arm Description

the patients were received paravertebral block to control pain postoperatively.

the patients were received transversus abdomins plane (TAP) block to control pain postoperatively.

Outcomes

Primary Outcome Measures

comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block
comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block by the following assessment methods: Visual Analogue Scale score (VAS) immediately postoperative and through the first 24 hours postoperativly, total analgesic consumption through the first 24 hours postoperatively, and time of first analgesic request in the postoperative period

Secondary Outcome Measures

Full Information

First Posted
December 29, 2020
Last Updated
January 30, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04697420
Brief Title
Transversus Abdominis Plane Block Versus Paravertebral Block for Post Operative Pain Relief in Open Renal Surgeries
Official Title
Transversus Abdominis Plane Block Versus Paravertebral Block for Post-operative Pain Relief Following Open Renal Surgeries: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 24, 2018 (Actual)
Study Completion Date
January 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. Study Description

Brief Summary
Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of many post operative complications . There are a lot of regional anesthetic techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block. TAP block has been used to provide postoperative analgesia in a lot of abdominal surgeries including upper abdominal surgeries.It is safer technique than PVB, but the effectiveness of TAP block is unknown in comparison with PVB in post operative analgesia after renal surgeries .
Detailed Description
Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of post operative respiratory complications . A lot of patients presented to these operations may have comorbidities as impaired renal function and respiratory problems , conditions like these may contraindicate aministration of systemic analgesia as opioids . There are a lot of techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block . Paravertebral block is effective technique for post operative analgesia for upper abdominal surgeries , but it may be associated with some complications as : pneumothorax , spread of local anesthetic to the epidural space and paravertebral blood vessels , and this may lead to systemic toxicity of local anesthetic . TAP block has been used to provide postoperative analgesia in a lot of abdominal surgeries including upper abdominal surgeries , but it is safer technique than PVB , but the effectiveness of TAP block is unknown in comparison with PVB in post operative analgesia after renal surgeries .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (P)
Arm Type
Experimental
Arm Description
the patients were received paravertebral block to control pain postoperatively.
Arm Title
Group (T)
Arm Type
Experimental
Arm Description
the patients were received transversus abdomins plane (TAP) block to control pain postoperatively.
Intervention Type
Procedure
Intervention Name(s)
Thoracic paravertebral block
Intervention Description
Thoracic paravertebral block is a technique in which , the local anesthetic agent is injected in the paravertebral space to anesthetise the spinal nerves after emerging from the vertebral canal in order to provide analgesia in the thoracic and upper abdominal area .
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block
Intervention Description
Transversus abdominis plane block is a technique is mostly done under ultrasound guidance to identify the transversus plane between the internal oblique muscle and the transverses abdominis muscle , the space in which the neurovascular supply of the anterior abdominal wall is present , and hence the injection of local anesthetic agent in this space results in anesthesia of the anterolateral aspect of the abdominal wall.
Primary Outcome Measure Information:
Title
comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block
Description
comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block by the following assessment methods: Visual Analogue Scale score (VAS) immediately postoperative and through the first 24 hours postoperativly, total analgesic consumption through the first 24 hours postoperatively, and time of first analgesic request in the postoperative period
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 - 60 years ASA I-II class Exclusion Criteria: Patient refusal Any contraindication of regional anesthesia block (Coagulopathy,infection at the needle insertion site) Patients with allergy to amide local anesthetics or medication included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Essam Ezzat, Professor
Organizational Affiliation
Professor of anesthesia, intensive care and pain management , formerly head of the department
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transversus Abdominis Plane Block Versus Paravertebral Block for Post Operative Pain Relief in Open Renal Surgeries

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