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

Postoperative Pain Clinical Trial

— LATAP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02400645
• Other study ID #: 14-132
• Status: Terminated
• Phase: Phase 1
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: March 2015
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Pre-incisional wound infiltration
Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions
• Laparoscope to place TAP block with liposomal bupivacaine
Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%

Drug:
• Liposomal bupivacaine
Use of Liposomal bupivacaine in laparoscopic TAP block
• Bupivacaine
20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.
• Ketorolac
Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Benefit of Anesthesia scores (OBAS) on postoperative days 1,2 and 7	Overall Benefit of Anesthesia Scores (OBAS) Questionnaires at postoperative days 1,2 and 7.; OBAS covers pain, vomiting, itching, sweating, freezing, dizziness and overall satisfaction on a scale of 0 to 10.	One week
Primary	Visual Analog pain scores (VAS)	Postoperative pain at 1 hour and 2 hours after arrival to recovery using Visual Analog Pain Scores (VAS); VAS: 0 (no pain) TO 10 (worst possible pain)	Two hours
Secondary	Narcotic pain medication usage	Narcotic pain medication usage intraoperative and in recovery assessed as morphine equivalents	2 hours postoperative
Secondary	Narcotic pain medication following surgery	Narcotic pain medication pill counts up to one week postoperatively	1 week