Local Wound Infiltration in Renal Surgery

NCT ID: NCT03601780

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2018-12-31

Brief Summary

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Multimodal analgesia is a rational approach to treat various components of postoperative pain.

Detailed Description

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Local anesthetic wound infiltration is widely recognized as a useful adjunct during multimodal postoperative pain management whether given before operation or perioperatively.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Local wound infiltration

local wound infiltration plus usual care

Group Type ACTIVE_COMPARATOR

local wound infiltration plus usual care

Intervention Type DRUG

local wound infiltration plus usual care

Control

usual care only

Group Type PLACEBO_COMPARATOR

usual care only

Intervention Type DRUG

usual care only

Interventions

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local wound infiltration plus usual care

local wound infiltration plus usual care

Intervention Type DRUG

usual care only

usual care only

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I or II, aged between 30 and 65 yr, and undergoing open renal surgery

Exclusion Criteria

* history of adverse reactions to local anaesthetics, chronic hepatic disease, chronic renal disease chronic pain, chronic preoperative opioid consumption, psychiatric disorders which would prevent postoperative assessments,
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Seham Mohamed Moeen Ibrahim

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Seham M Moeen, MD

Role: CONTACT

2413201 ext. 088

Other Identifiers

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SM62018

Identifier Type: -

Identifier Source: org_study_id

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