NCT03601780

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_2 postoperative-pain

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_2 postoperative-pain

Status
unknown

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

First Submitted

Initial submission to the registry

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

July 17, 2018

Last Update Submit

July 25, 2018

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

local wound infiltration plus usual careDRUG

local wound infiltration plus usual care

Local wound infiltration
usual care onlyDRUG

usual care only

Control

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Seham M Moeen, MD

CONTACT

2413201seham.moeen@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

August 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07