Recruiting
Phase 3

Local Anesthetic

Sponsor:

Ascension Health

Code:

NCT04173312

Conditions

Pain Control

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine infusion

Saline

Study Details

Brief summary:

Efficacy of using continuous infusion of local anesthetic for post operative pain control following laparotomy.

Conditions

Pain Control

Study ID

NCT04173312

Start date

Jan 4, 2021

Status verified date

Feb, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Jan, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

- Patients scheduled for elective laparotomy

Exclusion Criteria:

  • Emergency laparotomy
  • Pregnancy
  • Patients on chronic pain medication

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Infused analgesic

Patients will be assigned to receive local anesthetic through continuous infusion by pump.

placebo comparator: Infused saline

Patients will be assigned to receive saline through continuous infusion by pump.

Interventions

Bupivacaine infusion

Local systemic Infusion of anesthetic

Saline

Local systemic infusion of saline

Primary outcome measure

  • Self Reported Pain [ Time Frame: 5 days ]

Central Contacts and Locations

Central contacts

Tarik Wasfie, MD

8108539900twasfie@gmail.com

Kimberly Barber, PhD

8106067724kimberly.barber@ascension.org

Locations

Ascension Genesys Hospital

Recruiting

Grand Blanc, Michigan, United States, 48439

Contacts

Tarik Wasfie, MD

810-853-9900twasfie@gmail.com

Sandra Watt, RN

810-6067713sandra.watt@ascension.org

More Information

Sponsor

Ascension Health

Last update posted

Feb 23, 2022

Last verified

Feb, 2022

Keywords

  • local anesthetic
  • continuous infusion
  • pain control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ascension Health on 2022-02-23.