Analgesic Efficacy of Paravertebral Morphine

Analgesic Efficacy of Paravertebral Morphine for Acute Postoperative Pain: Randomized Multicenter Clinical Trial

The investigator will test the analgesic efficacy of paravertebral morphine as an adjuvant to local anesthetics for acute postoperative pain following breast surgery and renal surgery

Study Overview

• Status: Unknown
• Conditions: Acute Pain
• Intervention / Treatment: Drug: PVB morphine; Drug: PVB bupivacaine

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assuit
    • Assiut, Assuit, Egypt, 71515
      • Recruiting
      • Diab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Adult patients subjected to mastectomy or renal surgery

Exclusion criteria

• Patients complaining of coagulopathies
• Patients with vertebral anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PVB morphine	Drug: PVB morphine; The PVB was performed under ultrasonographic guidance in the sitting position. Surgical disinfection of thoracoabdominal paravertebral area was done. A linear high-frequency transducer (10-12 MHz, Sonosite, Bothell, WA, USA) was used. The scanning process (Longitudinal out-of-plane technique) was started at 5-10 cm lateral to the spinous process of thoracic vertebrae to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until the transverse processes are identified as more squared structure deeper to the ribs. A 100 mm needle was inserted out-of-plane to contact the transverse process of thoracic vertebra and then, walked off above the transverse process 1-1.5 cm deeper searching for loss of resistance injecting 10 ml of 0.25% bupivacaine + 3 mg morphine for group PVB morphine in incremental doses of 3 ml.
Active Comparator: PVB bupivacaine	Drug: PVB bupivacaine; the same steps mentioned in group PVB morphine but the solution used for paravertebral block contain bupivacaine only 10 ml of 0.25% bupivacaine injected in in incremental doses of 3 ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour postoperative morphine consumption	the quantity of analgesic (morphine) consumed by the patient in the first postoperative 24 hour	the first postoperative 24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS pain score (visual analogue pain score)	a scle in which 0 = no pain and 10 = maximum tolerable pain	we will assess every 4 hour in the first postoperative 24 hour

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: December 17, 2017
• First Submitted That Met QC Criteria: December 17, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: SECI-IRB-IORG0006563-404

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No