Postoperative Pain Control by Use of Many Drugs in Small... | NCT05186454

Studies
Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally

NCT05186454

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jan 28, 2022Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Post Operative Pain

Interventions

Morphine Sulfate
Bupivacaine
dexamethasone, morphine, midazolam

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 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2021Actual

Primary Completion Date

Feb 10, 2022Estimated

Completion Date

Feb 15, 2022Estimated

First Submitted Date

Dec 26, 2021

First Submission Date that Met QC Criteria

Jan 10, 2022

First Posted Date

Jan 11, 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

Jan 26, 2022

Last Update Posted Date

Jan 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam.

Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Morphine	Active Comparator	Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.	Drug: Morphine Sulfate Drug: Bupivacaine
Multimodal	Active Comparator	Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally	Drug: Bupivacaine Drug: dexamethasone, morphine, midazolam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Morphine Sulfate	Drug	analgesia	Morphine	bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1st analgesic requirement	The first time of supplemental analgesic need postoperatively	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Analgesic consumption	Total analgesic consumption	24 hours
Post operative pain	Visual Analog Scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

ASA I-II
Age 20-40 years.
Pregnant women with living fetus.
Body mass index 20- 35 kg/m2.

Exclusion criteria:

Patient refusal.
Age < 20 or > 40 years
Body mass index < 20 or > 35.
Contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, Systemic or local infection, increased intracranial pressure and hypovolemia).
Placental abnormalities: placental abruption, placenta previa or accrete.
Allergy to drugs used in the study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fouad Soliman	Contact	01113815186		fouad_soliman@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fouad Soliman	Recruiting	Sohag		52514	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

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

Intervention Browse Module

MeSH Terms

ID	Term
D009020	Morphine
D002045	Bupivacaine
D003907	Dexamethasone
D008874	Midazolam

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided