Transverse Abdominus Plane Block Study

Surgery Clinical Trial

— TAP  

Official title:

Effect of Laparoscopic-Guided Transversus Abdominus Plane (TAP) Block on Opioid Consumption Using Dual-Adjunct Therapy With Dexmedetomidine and Dexamethasone Versus Liposomal Bupivacaine (Exparel®) Following Minimally Invasive Colorectal Surgery: A Single-Blinded Randomized Clinical Trial.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05216055
• Other study ID #: 20-2574.cc
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 19, 2022
• Est. completion date: December 27, 2022

Study information

• Verified date: March 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery.

Description:

This is a non-inferiority single-blinded randomized trial aiming to study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery. This study aims to continue improving our current hospital wide effort in reducing opioid consumption and, consequently, the acute and long-term consequences of opioids. It will also complement the current ongoing efforts of the Department of Surgery's quality and safety improvement project in opioid stewardship. Additionally, this dual adjunct TAP solution combination is inexpensive ($28 per injection) and may result in a significant cost savings for the hospital.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 27, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• provision to sign and date the consent form.
• stated willingness to comply with all study procedures and be available for the duration of the study.
• Male and female patients aged 18 and older
• Benign or malignant colorectal disease undergoing laparoscopic, robotic, or a "hybrid" (minimally invasive dissection with a 6-8 cm incision to complete the surgery) colorectal resection with or without an ostomy

Exclusion Criteria:

• Pregnant or breastfeeding patients
• Medical conditions that may interfere with the use of the study medications (e.g., drug allergy),
• Patients with opioid dependence defined as chronic opioid use more than 3 times per week preoperatively
• Incarcerated individuals
• Age less than 18 years-old
• Urgent/emergent operations as defined by need for operation within 24 hours
• Other conditions or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
• Enrollment in another concurrent study with use of investigational drugs

Related Conditions & MeSH terms

• Colorectal Disorders
• Surgery

Intervention

Combination Product:
• Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline
Ropivacaine 0.5% HCl, 40 mL (5 mg per mL) (200 mg) Dexmedetomidine HCl, 0.50 ml (100 ug per mL) (50 ug) Dexamethasone sodium phosphate, 1 mL (10 mg per mL) (10 mg) Normal saline 0.9%, 18.5mL

Drug:
• Liposomal bupivacaine
Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative opioid consumption in the first 72 hours	Total amount of both intravenous and oral opioid use in the first 72 hours after surgery measured in morphine milligram equivalents.	72 hours
Primary	Post-operative opioid consumption over hospital stay	Total morphine dose equivalents administered throughout hospital stay	2 months
Primary	Visual analog scale pain scores in the PACU	Visual analog scale (VAS) pain scores in the PACU	72 hours
Primary	Visual analog scale pain scores 12 hours post op	Visual analog scale pain scores 12 hours post op	12 hours
Primary	Visual analog scale pain scores 24 hours post op	Visual analog scale pain scores 24 hours post op	24 hours
Primary	Visual analog scale pain scores 36 hours post op	Visual analog scale pain scores 36 hours post op	36 hours
Primary	Visual analog scale pain scores 48 hours post op	Visual analog scale pain scores 48 hours post op	48 hours
Primary	Visual analog scale pain scores 72 hours post op	Visual analog scale pain scores 72 hours post op	72 hours
Primary	Epidural need	Need for an epidural post-operatively. Reviewed using the EMR.	2 months
Primary	Need for postoperative patient-controlled analgesia (PCA)	Determined by review of EMR. Patients use or non-use of PCA.	72 hours
Primary	Need for adjunctive systemic nonopioid pain medications	Adjunctive systemic nonopioid pain medications	2 months
Primary	Prescribed opioid at discharge	Amount of opioid prescribed at discharge	2 months
Primary	Outpatient narcotic refill	Use the EMR to determine outpatient narcotic refill	2 months
Secondary	Length of hospital stay	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on length of hospital stay following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Calculating the length of hospital stay will allow for evaluation of effectiveness of dual adjunct therapy in context of ERAS protocol compared to liposomal bupivacaine	2 months
Secondary	Use of antiemetics in the first 12 hours post op	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.	12 hours
Secondary	Use of antiemetics in the first 24 hours post op	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.	24 hours
Secondary	Use of antiemetics in the first 36 hours post op	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.	36 hours
Secondary	Use of antiemetics in the first 48 hours post op	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.	48 hours
Secondary	Use of antiemetics in the first 72 hours post op	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.	72 hours
Secondary	Time to first flatus	Days from surgery to first flatus postoperatively. Reviewed using the EMR.	2 months
Secondary	Time to first bowel movement	Days from surgery to first bowel movement postoperatively. Reviewed using the EMR.	2 months
Secondary	Need to insert nasogastric tube	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Reviewed using the EMR.	2 months