Multimodal and Unimodal Analgesia in Cholecystectomy | NCT05547659

Studies
Multimodal and Unimodal Analgesia in Cholecystectomy

NCT05547659

Sponsor

October 6 University

Status

Completed

Last Update Posted

Sep 21, 2022Actual

Enrollment

95Actual

Phase

Phase 1Phase 2

Conditions

Compare Unimodal and Multimodal Analgesics

Interventions

Pregabalin 150mg
Acetaminophen 1 G Oral Tablet
Celecoxib 400Mg Oral Capsule

Countries

Egypt

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

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Apr 1, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Aug 25, 2022

First Submission Date that Met QC Criteria

Sep 19, 2022

First Posted Date

Sep 21, 2022Actual

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

Sep 19, 2022

Last Update Posted Date

Sep 21, 2022Actual

Name	Class
Beni-Suef University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation

Detailed Description

Not provided

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
multimodal	Active Comparator	pregabalin/ acetaminophen/ celecoxib	Drug: Pregabalin 150mg Drug: Acetaminophen 1 G Oral Tablet Drug: Celecoxib 400Mg Oral Capsule
unimodal	Active Comparator	Pregabalin	Drug: Pregabalin 150mg
control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin 150mg	Drug	Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group	multimodal unimodal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative visual analogue scale (VAS)	The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.	24 hour postoperative
Amount of post operative Needed opioid analgesia	ampules of opioid analgesia needed after operation	24 hour postoperative

Secondary Outcomes

Measure	Description	Time Frame
Type and amount of prescribed post operative non opioid analgesia	Type and amount of prescribed post operative non opioid analgesia	24 hour postoperative

Other Outcomes

Measure	Description	Time Frame
Reported opioid side effects	Side effects reported after opioid administration eg. nausea, vomiting, respiratory depression etc..	24 hour postoperative

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing laparoscopic cholecystectomy
Patients older than 18 years old

Exclusion Criteria:

Renal or hepatic or cardiac impairment patients
Patients with chronic pain history
Allergic patients after taking aspirin or other NSAIDs
patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni suef University hospital		Banī Suwayf			Egypt
Beni-Suef Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069583	Pregabalin
D000082	Acetaminophen
D013607	Tablets
D000068579	Celecoxib

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

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Browse Branches

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