Erector Spinae Block With Ropivacaine and Dexmedetomidine... | NCT05664542

Studies
Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries

NCT05664542

Sponsor

Security Forces Hospital

Status

Unknown status

Last Update Posted

Feb 23, 2023Actual

Enrollment

42Estimated

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

ESPB (regional Block)
ropivacaine and dexmedetomidine

Countries

Saudi Arabia

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

Feb 2023

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

Dec 15, 2022Actual

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

May 30, 2023Estimated

First Submitted Date

Nov 20, 2022

First Submission Date that Met QC Criteria

Dec 22, 2022

First Posted Date

Dec 23, 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

Feb 21, 2023

Last Update Posted Date

Feb 23, 2023Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block in reducing opioid consumption for patients undergoing lumbar spine surgeries. This study will help in understanding the role of adding dexmdetomidine to ropivacaine in erector spinae block in reducing opioid consumption after lumbar spine surgeries

Detailed Description

A number of adjuvants have been used with local anesthetics including dexamethasone, nalbuphine and dexmedetomidine etc with the aim of improving quality and duration of peripheral nerve blocks. Dexmedetomidine is a potent alpha-2 agonist which can prolong the duration of regional anesthesia block when used in combination with local anesthetics. Although, there is no consensus on the dose of dexmedetomidine for peripheral nerve block considering the fact that it can lower heart rate and blood pressure intraoperatively. Investigators therefore, planned this randomised controlled trial to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block for patients undergoing lumbar spine surgeries.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESPB group	Experimental	this group will receive ESPB using ropivacaine and dexmedetomidine	Other: ESPB (regional Block) Drug: ropivacaine and dexmedetomidine
Control group	No Intervention	this group will not receive any block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ESPB (regional Block)	Other	ESPB is regional block in which we will use 0.2 % ropivacaine and dexmedetomidine	ESPB group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24 hours opioid consumption	opioid consumption in mg during first 4 hours postoperatively	24 hours

Secondary Outcomes

Measure	Description	Time Frame
pain score	pain score in Numerical rating score during first 24 hours postoperatively	24 hours
Occurrence of postoperative nausea and vomiting (PONV)	Occurrence of postoperative nausea and vomiting (PONV) during first 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged between 18 and 70 years, scheduled to undergo lumbar spine surgeries with an ASA score of 1 to 3 will be included in the study

Exclusion Criteria:

Patients who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with either contraindications for regional anesthesia, known allergy to local anesthetics or dexmedetomidine, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications will not be included in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anwar ul huda, FRCA	Contact	00966118024331	4331	hudaanwar90@yahoo.com

Overall Officials

Name	Affiliation	Role
Anwar ul Huda, FRCA	Security Forces Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Security Forces Hospital	Recruiting	Riyadh			Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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
D000077212	Ropivacaine
D020927	Dexmedetomidine

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Quadruple

Masking Description

Procedure will be done after patient will undergo GA for surgery. Medications will be prepared by anesthetist not involved in the study. The nurse/doctor who will assess the outcome will not know the group allocation

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor