Implications of Different Analgesic Models on Inflammator... | NCT04609033

Studies
Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

NCT04609033

Sponsor

Assiut University

Status

Completed

Last Update Posted

Aug 30, 2021Actual

Enrollment

110Actual

Phase

Not Applicable

Conditions

Perioperative Pain

Interventions

Bupivacaine
isotonic saline
Bupivacaine + morphine
Bupivacaine + morphine + ketamine

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

Aug 2021

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

Oct 24, 2020Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

Mar 30, 2021Actual

First Submitted Date

Sep 3, 2020

First Submission Date that Met QC Criteria

Oct 23, 2020

First Posted Date

Oct 30, 2020Actual

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

Aug 27, 2021

Last Update Posted Date

Aug 30, 2021Actual

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

Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively

Detailed Description

The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1.

The residual part of CO2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
bupivacaine group	Active Comparator	Drug: Bupivacaine
bupivacaine + morphine	Active Comparator	Drug: Bupivacaine + morphine
bupivacaine + morphine + ketamine	Active Comparator	Drug: Bupivacaine + morphine + ketamine
isotonic saline	Placebo Comparator	Drug: isotonic saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine	Drug	instillation of local anaesthetic in the abdominal cavity at the end of the procedure	bupivacaine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative level of ACTH hormone	a stress marker that increase with pain and surgery	6 hours

Secondary Outcomes

Measure	Description	Time Frame
VISUUEAL ANALOGE SCORE	to assess postoperative pain	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for Laparoscopic cholecystectomy.
Age spectrum of 18 - 55 years
ASA I, II
Have no comorbid chronic medical diseases

Exclusion Criteria:

Patients with co morbid medical diseases
Age outside the specified range
Acute inflammation of the gall bladder
Critically ill patient
Emergency operations
Patient refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 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
Assiut University Hospitals		Asyut		71515	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D012965	Sodium Chloride
D009020	Morphine
D007649	Ketamine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided