TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy

Acute Pain Clinical Trial

Official title:

Ultrasound Guided Subcostal Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine vs Bupivacaine in Robotic Hysterectomy Patients: A Prospective Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289079
• Other study ID #: 1305m34041
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare pain control after robotic hysterectomy surgery using either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are standard of care in these types of surgeries.

Description:

Treatment technique: The patient will be in the supine position. The transversus abdominis muscle layer will be identified with the ultrasound. Using sterile technique, skin infiltration with 2% lidocaine will occur, 2 cm medial to the ultrasound probe. An 22g Nerve block needle will then be inserted and advanced under ultrasound guidance until it is below the fascial covering of the transversus abdominis muscle layer. Gentle aspiration for air, or blood will be performed and either 30 cc of 0.25% bupivacaine with 1/200,000 parts epinephrine or 30 mL of liposomal bupivacaine mixed 1:1 with normal saline will be injected under ultrasound guidance. For each 5cc of local anesthetic injected, aspiration will be performed. Upon completion of the injection, the needle will then be removed. This will then be completed on the contralateral side. The patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure. When the operation is complete the patient will either be discharged home or brought to the ward where each day a member of the research team will evaluate the patient for signs of complications and ask the patient their minimum and maximum pain score. If patients have met criterion for discharge to home including pain <4/10, independence of intravenous analgesia, and are stable for discharge medically, but are awaiting placement, the time of discharge for the purposes of the study will be the day they have met such criterion as opposed to the day of actual discharge, as this can vary depending on patient placement. If the patient is discharged prior to 72 hours post injection, then the patient will receive one phone call at 24 hours post injection, 48 hours post injection , and 72 hours post injection +/- 5 hours. During this phone call the patient will be asked about pain score, narcotic use, overall satisfaction via a recorded patient questionnaire, quality of recovery via a quality of recovery survey, and assessed if any adverse events have occurred. Adequate analgesia will be defined as <3 VAS at rest, and if VAS is greater than 3 adjustments in oral or intravenous pain medications will be given as determined by the nurse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• those who present for elective robotic assisted hysterectomy

Exclusion Criteria:

• non english speaking
• chronic pain
• on opioids greater than 1 weeks
• chronic anticoagulation
• allergy to local anesthetics
• use of spinal or epidural for surgery
• lack of patient cooperation
• contraindication to regional anesthesia

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Bupivacaine

• liposomal bupivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Opioid Use	To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block	0-72 hours after injection
Secondary	Numerical Rating Scale	This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.	48-72 hours
Secondary	Post Operative Length of Stay	To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block	up to 30 days after surgery
Secondary	Patient Satisfaction as Assessed Via Patient Survey	To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.	assessed at 72 hours after injection