Local Wound Infiltration in Renal Surgery | NCT03601780

Studies
Local Wound Infiltration in Renal Surgery

NCT03601780

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 26, 2018Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Postoperative Pain

Interventions

local wound infiltration plus usual care
usual care only

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2018Estimated

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jul 17, 2018

First Submission Date that Met QC Criteria

Jul 25, 2018

First Posted Date

Jul 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2018

Last Update Posted Date

Jul 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Local wound infiltration	Active Comparator	local wound infiltration plus usual care	Drug: local wound infiltration plus usual care
Control	Placebo Comparator	usual care only	Drug: usual care only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
local wound infiltration plus usual care	Drug	local wound infiltration plus usual care	Local wound infiltration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain	Visual analogue scale ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain.	The first 48 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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,

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seham M Moeen, MD	Contact	2413201	088	seham.moeen@yahoo.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided