Paravertebral Block vs no Block in Open Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

Official title:

Paravertebral Block vs no Block in Open Pancreaticoduodenectomy: Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820997
• Other study ID #: 22-012297
• Status: Recruiting
• Phase: Phase 4
• Start date: April 24, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Mauricia Buchanan
• Phone: 904-953-2077
• Email: Buchanan.Mauricia[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare intra and postoperative pain control between Paravertebral block vs no block in open pancreaticoduodenectomy. Length of stay, and complications will also be recorded. For this study the investigator plans to randomize to obtain objective data for clinical decisions and improve patient outcomes. Following surgery patients in both groups, data will be collected from the first 48 hours after surgery and at discharge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients willing and have signed consent.
• Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB)

Exclusion Criteria:

• Not able or unwilling to sign consent.
• Currently pregnant or lactating.
• Patients with chronic pain, requiring daily opiate use at time of surgery.
• Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

Intervention

Drug:
• Ropivacaine
Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean post-operative pain score	Measured using pain visual analog scale, with pain scale ranging from 0 to 10 (0=no pain; 10=worst possible pain)	First 48 hours after surgery
Secondary	Hospital Length of Stay	Total number of days subjects were admitted to the hospital following surgery	Approximately 2-4 days
Secondary	Number of subjects with a bowel obstruction	Number of subjects to experience a bowl obstruction following surgery	Approximately 2-4 days