Analgesic Efficacy of Paravertebral Morphine

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03379987
• Other study ID #: SECI-IRB-IORG0006563-404
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 2019

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria

• Adult patients subjected to mastectomy or renal surgery

Exclusion criteria

• Patients complaining of coagulopathies

• Patients with vertebral anomalies

Related Conditions & MeSH terms

• Acute Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Diab	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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