Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block

NCT02801188 | Completed DMC

• 1 other identifier: MD ∕ 128
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Fracture femur is a common that results in severe pain. Many methods of regional and peripheral analgesia have been described to treat such pain. In this study the investigators consider using paravertebral block to treat post-fracture pain. Additionally, they consider adding dexmedetomidine to the used local anesthetic solution to prolong the duration of this block and hence postoperative analgesia.

Conditions

Fracture of Proximal Femur

Outcome Measures

Primary Outcomes (1)

• Scale for radiological spread of the injectate

  It will be assessed using the following scale -2; spread for two vertebral levels below the site of injection, -1; spread for one vertebral level below the site of injection, 0; stays at the level of injection, +2; spread for two vertebral levels above the site of injection, +1; spread for one vertebral level above the site of injection

  for 20 min after performing the blockade

Secondary Outcomes (3)

• Pain scores

  For 48 hours after surgery

• Duration of postoperative analgesia

  for 24 hours after surgery

• Postoperative analgesic consumption

  for 48 hours after surgery

Study Arms (2)

Bupivacaine group

PLACEBO COMPARATOR

Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.

Drug: Bupivacaine

Mixture of bupivacaine and dexmedetomidine group

ACTIVE COMPARATOR

Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye and 1 ug/kg of dexmedetomidine

Drug: Mixture of bupivacaine and dexmedetomidine

Interventions

Bupivacaine DRUG

Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.

Bupivacaine group

Mixture of bupivacaine and dexmedetomidine DRUG

Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine

Mixture of bupivacaine and dexmedetomidine group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical class I or II

You may not qualify if:

• Patient refusal.
• Severe or uncompensated cardiovascular disease.
• Severe or uncompensated renal disease.
• Severe or uncompensated hepatic disease.
• Severe or uncompensated endocrinal disease.
• Pregnancy.
• Postpartum ladies.
• Lactating females.
• Allergy to any of the study medications .
• Coagulation disorders.
• Infection at the site of needle insertion

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Reem A El sharkawy, MD

  Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

  PRINCIPAL INVESTIGATOR

• Mohamed Y Makharita, MD

  Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

  STUDY DIRECTOR

• Nabil Abd-El Raouf, MD

  Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: June 15, 2016
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

EG (1)