NCT04697420

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

December 29, 2020

Last Update Submit

January 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours

Study Arms (2)

Group (P)

EXPERIMENTAL

the patients were received paravertebral block to control pain postoperatively.

Procedure: Thoracic paravertebral block

Group (T)

EXPERIMENTAL

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

Procedure: Transversus abdominis plane block

Interventions

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 .

Group (P)

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.

Group (T)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Essam Ezzat, Professor

    Professor of anesthesia, intensive care and pain management , formerly head of the department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

December 29, 2020

First Posted

January 6, 2021

Study Start

November 1, 2017

Primary Completion

October 24, 2018

Study Completion

January 23, 2019

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations