Analgesic Efficacy of Paravertebral Morphine

NCT ID: NCT03379987

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-08-31

Brief 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

Conditions

Acute Pain

Study Design

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

Study Groups

PVB morphine

Group Type: EXPERIMENTAL

PVB morphine

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

PVB bupivacaine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients subjected to mastectomy or renal surgery

Exclusion Criteria

• Patients complaining of coagulopathies
• Patients with vertebral anomalies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Diab Fuad Hetta

anesthesia and pain management departmewnt, SECI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Diab

Asyut, Assuit, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Diab Hetta, MD

Role: primary

diabgetta25@gmail.com

+201091090009

Other Identifiers

SECI-IRB-IORG0006563-404

Identifier Type: -

Identifier Source: org_study_id