Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management

Pain, Postoperative Clinical Trial

Official title:

Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Unilateral Deep Inferior Epigastic Perforator Free Flap Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284930
• Other study ID #: 15-1535
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: November 2017

Study information

• Verified date: December 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.

Description:

Critical to patient recovery, and can contribute to faster patient mobilization, shorter hospital stays and reduced health care costs. The administration of local anesthetics via wound infiltration is standard of care and an effective practice for post surgical pain management, However this method only provides relatively brief analgesia, usually lasting only 12 hours. Other FDA approved delivery systems using an indwelling fusion pump catheter (On-Q pump) are currently being used in our practice and may be used to extend the duration of action of locally administered analgesia by continuously infusing anesthetic into the wound. Alternatively, a depot form of bupivacaine has been FDA approved and currently used to deliver a single dose administered via wound infiltration for prolonged analgesia by allowing for the diffusion of the drug over an extended period of time. Both of these products are used as a standard practice during DIEP free flap reconstructions. However, no studies compare the efficacy of these two methods patients undergong unilateral DIEP flap reconstructions has been done in a prospective, randomized control manner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non pregnant women

• age 18 years or older

• scheduled to have unilateral DIEP flap breast reconstruction.

• Must have ASA physical status classification of 1,2, or 3

Exclusion Criteria:

• concurrent or recent medical condition that could interfere with study participation

• history of any of the following:

• hepatitis

• alcohol/substance abuse

• uncontrolled psychiatric disorders

• known allergy/ contraindication to any of the following:

• amide-type local anesthetics

• opioids

• propofol

• Body weight of less than 50 kg

• have participated in another study involving an investigational medication with in the past 30 days

• taking analgesics, antidepressants, or glucocorticoids within the 3 days before surgery

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Depobupivacaine
surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia.
• OnQ pump
group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure.
• 0.25% Bupivacaine
group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Narcotic Usage	Post-op pain measured by total post-op Morphine equivalents	total hospital stay, an average of 3 days