Oral Pregabalin Effect to the Intravenous Morphine in Multiple Fracture Ribs

NCT ID: NCT03473093

Last Updated: 2018-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2019-04-30

Brief Summary

Determine the effect of using oral pregabalin on the analgesic effects of IV infusion of morphine in patients with multiple fracture ribs.

Detailed Description

Blunt chest trauma accounts for a significant proportion of debilitating and life-threatening injuries. Rib fractures are notoriously painful and can lead to prolonged hospitalization,contribute to the development of pneumonia and respiratory failure, and delay outpatient recovery significantly.Flail chest, along with chest wall deformity, the most severe of chest wall injuries, is associated with significant acute morbidity and mortality.Flail chest injury has been associated with a high mortality rates historically and up to 16 % more recently. In-patients with physiologic flail visibly apparent paradoxical chest wall motion leads to inefficient respiratory effort and compression of the lung and diminishes the negative intra thoracic pressure essential for the passive movement of air into the bronchial tree. Atelectasis leads to increased lung resistance and decreased compliance, making the work of breathing much more difficult. Loss of the ability to generate negative intra thoracic pressure with breathing also impairs venous return, a passive process dependent on the negative intra thoracic pressure generated with each breath. In patients without a visible flail segment, i.e., an anatomic or radiologic flail,the physiologic derangements can be similarly destructive.There is mounting evidence that a patient's perception of pain in the early post-injury period is associated with chronic pain development . A recent prospective study of rib fracture patients found that pain and disability at 8 weeks post injury could be predicted by the pain intensity within the first few days after injury . Interestingly, the number of fractures and the bilaterality of fractures were not predictive. Thus, pain management in the early post-injury setting is likely paramount to obtaining a more favorable recovery. Opioids, are traditional first-line therapy for acute rib fracture pain. But because of chronic misuse potential and central desensitization concerns, pain researchers and clinicians are increasingly recommending that opioids be used only in combination with other analgesic modalities such acetaminophen, nonsteroidal anti-inflammatory medication(NSAID), the anticonvulsants gabapentin and pregabalin,and the topical lidocaine patch

Conditions

Fracture; Rib, Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

morphine

This group will receive only morphine infusion (20microgram/kg/h)

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

One group will receive morphine infusion 20 microgram/kg/h

pregabalin

This group will receive only morphine infusion (20microgram/kg/h) and oral pregabalin (150 mg)

Group Type: ACTIVE_COMPARATOR

Pregabalin 150mg

Intervention Type: DRUG

One group will receive oral pregabalin with morphine infusion

Morphine

Intervention Type: DRUG

One group will receive morphine infusion 20 microgram/kg/h

Interventions

Pregabalin 150mg

One group will receive oral pregabalin with morphine infusion

Intervention Type: DRUG

Morphine

One group will receive morphine infusion 20 microgram/kg/h

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients above 18 years old
• ASA [1] and ASA [2]
• mentally competent and able to give consent for enrollment in the study

Exclusion Criteria

• Patient coma scale less than 10
• Impaired kidney functions
• Chronic pain syndromes and patients with chronic opioid use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mina Medhat Mahfouz Eshak

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

khaled mohamad morsy, PhD

Role: CONTACT

khaledmorsy@gmail.com

01090477966

References

Cannon RM, Smith JW, Franklin GA, Harbrecht BG, Miller FB, Richardson JD. Flail chest injury: are we making any progress? Am Surg. 2012 Apr;78(4):398-402.

Reference Type: BACKGROUND

PMID: 22472394 (View on PubMed)

Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.

Reference Type: BACKGROUND

PMID: 8722735 (View on PubMed)

Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

Reference Type: BACKGROUND

PMID: 3785962 (View on PubMed)

Other Identifiers

pain in multiple fracture ribs

Identifier Type: -

Identifier Source: org_study_id