TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain

Comparison of Laparoscopically Assisted Transversus Abdominis Plane Block Using Liposomal Bupivacaine With Pre-incisional Bupivacaine for Post-operative Pain Control in Patients Undergoing Laparoscopic or Robotic Hysterectomy

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02400645

Acronym

LATAP

Enrollment

Registered

2015-03-27

Start date

2015-03-31

Completion date

2016-05-31

Last updated

2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

laparoscopic hysterectomy, robotic assisted hysterectomy

Brief summary

In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.

Detailed description

Patients undergoing laparoscopic or robotic assisted total hysterectomy at Erlanger Hospital will be randomized into one of two groups to receive either laparoscopic assisted TAP block with liposomal bupivacaine and bupivacaine (Group A) or pre-incisional bupivacaine (Group B). The remaining aspects of the perioperative care, including the general anesthesia care and postoperative care will be similar for all patients. Ideally, patients will be informed and consented for the study in the preoperative clinic setting. They will be randomized in the pre-anesthesia care unit. Patients in Group A will receive laparoscopic-assisted bilateral TAP blocks using 10cc liposomal bupivacaine, 10cc Bupivacaine 0.25% and 10cc Normal Saline one each side. Patients in Group B will receive a total of 20cc pre-incisional Bupivacaine divided between each of the trocar sites. All patients will receive Ketorolac 30 mg, IV at the conclusion of surgery. All patients will be offered either oral pain medications or patient controlled anesthesia (PCA) opiate pain medication as indicated. Morphine equivalents will be calculated. Postoperative pain control will be assessed using Visual Analog Pain Score (VAS). This will be done by recovery room personnel who will be blinded as to whether the patients received TAP block or pre-incisional anesthetic. VAS will be assessed at rest at 1 hour and 2 hours after arrival to PACU. Patients will be assessed with Overall Benefit of Anesthesia Score (OBAS) questionnaires at postoperative days 1, 2 and 7. OBAS questionnaires will be done by personnel blinded to anesthesia technique. Patients will also be blinded as to which group they were in. Total morphine equivalents of intraoperative and postoperative pain medications will be calculated through postoperative day 7.

Interventions

PROCEDUREPre-incisional wound infiltration

Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions

PROCEDURELaparoscope to place TAP block with liposomal bupivacaine

Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%

DRUGLiposomal bupivacaine

Use of Liposomal bupivacaine in laparoscopic TAP block

DRUGBupivacaine

20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.

DRUGKetorolac

Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* ASA physical status 1-3, * Scheduled for laparoscopic or robotic assisted laparoscopic hysterectomy, * Able to participate personally or by legal representation in informed consent

Exclusion criteria

* History of relevant allergy to the study drugs (Bupivacaine), * Chronic opioid use or drug abuse history, * Inability to understand the study protocol, * Refusal to provide written consent, * Soft tissue infection of the abdominal wall and skin

Design outcomes

Primary

Measure	Time frame	Description
Visual Analog pain scores (VAS)	Two hours	1. Postoperative pain at 1 hour and 2 hours after arrival to recovery using Visual Analog Pain Scores (VAS) 2. VAS: 0 (no pain) TO 10 (worst possible pain)

Secondary

Measure	Time frame	Description
Narcotic pain medication usage	2 hours postoperative	Narcotic pain medication usage intraoperative and in recovery assessed as morphine equivalents
Narcotic pain medication following surgery	1 week	Narcotic pain medication pill counts up to one week postoperatively

Other

Measure	Time frame	Description
Overall Benefit of Anesthesia scores (OBAS) on postoperative days 1,2 and 7	One week	1. Overall Benefit of Anesthesia Scores (OBAS) Questionnaires at postoperative days 1,2 and 7. 2. OBAS covers pain, vomiting, itching, sweating, freezing, dizziness and overall satisfaction on a scale of 0 to 10.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026