Pre-emptive Paracetamol for Prevention of Intraoperative... | NCT04038307

Studies
Pre-emptive Paracetamol for Prevention of Intraoperative Shoulder Tip Pain

NCT04038307

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 27, 2020Actual

Enrollment

120Actual

Phase

Phase 2Phase 3

Conditions

Cesarean Section

Interventions

paracetamol
Saline Solution

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Feb 1, 2020Estimated

Completion Date

Feb 1, 2020Estimated

First Submitted Date

Jul 24, 2019

First Submission Date that Met QC Criteria

Jul 26, 2019

First Posted Date

Jul 30, 2019Actual

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

Jan 22, 2020

Last Update Posted Date

Jan 27, 2020Actual

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

the aim is to determine the efficacy of Paracetamol in reducing the incidence and severity of intraoperative shoulder pain in patients undergoing cesarean section.

Detailed Description

pregnant females scheduled for cesarean section under spinal anesthesia will be enrolled . two groups of patents will be recruited . the study group will receive paracetamol pre operative .

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	Placebo Comparator	will receive 100 ml of saline	Drug: Saline Solution
paracetamol group	Experimental	will receive 1gm paracetamol (100ml)	Drug: paracetamol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
paracetamol	Drug	1gm	paracetamol group
Saline Solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence shoulder tip pain	presence of shoulder tip pain	intraoperative

Secondary Outcomes

Measure	Description	Time Frame
numerical rating scale	severity of shoulder tip pain (0-10) where 0 is no pain and 10 is the worst pain ever	intraoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy pregnant women (ASA II) having singleton pregnancy at term (≤ 37 weeks of gestation) aged between 18 and 40 years.

Exclusion Criteria:

Patients having allergy to study drug,
gestational diabetes
cardiovascular or biliary disorders
asthma
renal impairment
preeclampsia
any chronic pain condition or trauma in the shoulder, forearms or upper limbs
patients with any contraindication to SA were excluded from the study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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
Faculty of medicine		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided