Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

Hysterectomy Clinical Trial

Official title:

Mixture of Liposomal Bupivicaine and Bupivicaine Hydrogen Chloride (HCl) May Provide Faster and Longer Lasting Analgesia in Transversus Abdominis Block for Patient Having Open Abdominal Hysterectomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250507
• Other study ID #: IRB 10655
• Status: Completed
• Phase: Phase 4
• Start date: March 13, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: November 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.

Description:

All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective open abdominal hysterectomy with midline incision, age > 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.

Exclusion Criteria:

• Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Drug:
• Bupivacaine
0.25% bupivacaine for TAP block
• Liposomal bupivacaine
Exparel for TAP block
• Saline
Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)	Total opioid consumption	0 - 72 hours post-operatively
Primary	Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given	time to first opioid given	0 - 72 hours post-operatively
Secondary	Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied	Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.	0 - 72 hours post-operatively
Secondary	Length of Stay in the Hospital	Length of stay in the hospital, maximum time until discharge from the hospital	until the patient is discharged from the hospital
Secondary	Number of Patients With Local Anesthetic Toxicity	Presence of local anesthetic toxicity	0 - 72 hours post-operatively
Secondary	Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure	Presence of hemodynamic instability	0 - 72 hours post-operatively
Secondary	Pain Scores Using Visual Analogue Scale ( 0-10)	Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.	0-24 postoperative pain scores