Analgesia for Thyroidectomy Using Bilateral Superficial C... | NCT05180214

Studies
Analgesia for Thyroidectomy Using Bilateral Superficial Cervical Plexus Block With Bupivacaine Only or Adding Ketorolac to it.

NCT05180214

Sponsor

Sohag University

Status

Completed

Last Update Posted

Jan 21, 2022Actual

Enrollment

46Actual

Phase

Phase 2

Conditions

Thyroid Goiter
Thyroid Nodule

Interventions

Bupivacain
Ketorolac

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2021Actual

Primary Completion Date

Aug 19, 2021Actual

Completion Date

Sep 15, 2021Actual

First Submitted Date

Dec 17, 2021

First Submission Date that Met QC Criteria

Dec 17, 2021

First Posted Date

Jan 6, 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 6, 2022

Last Update Posted Date

Jan 21, 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

Thyroidectomy is considered a common operation with moderate to severe postoperative pain in some patients. Patients are divided into two groups. Bupivacaine group received bilateral superficial cervical plexus block (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of normal saline on each side and the Bupivacaine Ketorolac group received (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of ketorolac (15 mg) on each side.

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

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bupivacaine	Active Comparator		Drug: Bupivacain
bupivacaine and ketorolac	Active Comparator		Drug: Bupivacain Drug: Ketorolac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacain	Drug	analgesic	bupivacaine bupivacaine and ketorolac

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
postoperative pain	visual analogue scale(0-10) 0=no pain and 10=severe intolerable pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 20-50 years
ASA I-II patients
Patients going to do thyroid surgeries under general anesthesia

Exclusion Criteria:

Patient refusal
Known history of sensitivity to the drug used in the study
Drug abuse
Infection at the site of the block
Presence of coagulopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 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
Sohag University Faculty of Medicine		Sohag		52514	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D006042	Goiter
D016606	Thyroid Nodule

Ancestor Terms

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases
D013964	Thyroid Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D020910	Ketorolac

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided