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

NCT05664542 | Unknown Phase 4 DMC

• 1 other identifier: SFH-ESPB Dex
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 24 hours opioid consumption

  opioid consumption in mg during first 4 hours postoperatively

  24 hours

Secondary Outcomes (3)

• pain score

  24 hours

• Occurrence of postoperative nausea and vomiting (PONV)

  24 hours

• Occurrence of drowsiness

  24 hours

Study Arms (2)

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

ESPB (regional Block) OTHER

ESPB is regional block in which we will use 0.2 % ropivacaine and dexmedetomidine

ESPB group

ropivacaine and dexmedetomidine DRUG

0.2 % ropivacaine and dexmedetomidine

ESPB group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Security Forces Hospital: lead

Study Sites (1)

Security Forces Hospital

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anwar ul Huda, FRCA

  Security Forces Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anwar ul huda, FRCA

CONTACT

00966118024331; hudaanwar90@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 2 groups, one with block and other with no block

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: December 23, 2022
• Study Start: December 15, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

SA (1)