Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery

Not Applicable

Completed

• Conditions: Conditions Requiring Colorectal Surgery
• Interventions: Drug: Intrathecal hydromorphone; Drug: EXPAREL

• Registration Number: NCT02356198
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is prospective, randomized trial in which EXPAREL TAP block is compared to standard IT opioid administration, in relieving postoperative pain, decreasing length of stay, and use of narcotic medication.

Detailed Description

Primary Objective To assess efficacy of EXPAREL TAP blocks in improving pain scores for 48 hours postoperatively, and in reducing total oral morphine equivalents (OME) use, compared to standard Intrathecal opioid administration (IT).

Secondary Objective Assess the length of stay (LOS), postoperative ileus (POI) incidence, and the use of intravenous patient controlled analgesia (PCA) in patients that had EXPAREL TAP blocs compared to IT.

Study Timeline

• Study First Submitted: 2015-01-31
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-05
• Study Start: 2015-03
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Results First Submitted: 2019-01-15
• Results First Submitted QC: 2019-01-15
• Results First Posted: 2019-02-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

• • All patients undergoing elective laparoscopic or open colorectal resections who are eligible for IT

  • Age >18 years
  • BMI <40
  • Ability to understand and read English

Exclusion Criteria

• • Not able or unwilling to sign consent.

  • Currently pregnant or lactating.
  • Patients with chronic pain, requiring daily opiate use at time of surgery.
  • Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
  • Patients requiring emergent surgery.
  • Abdominoperineal resections
  • Any contraindications to neuraxial analgesia (coagulopathy, localized infection at the potential site of injection, pre-existing spinal canal pathology)
  • Patients with a diagnosis of inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal opioid (IT)	Intrathecal hydromorphone	single injection intrathecal hydromorphone analgesia given preoperatively
TAP block (EXPAREL)	EXPAREL	After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.

Primary Outcome Measures

Name	Time	Method
Mean Pain Score	First 48 hours post operative	Postoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation.
Total Morphine Milligram Equivalents Use (MME)	First 48 hours post operative	The total cumulative use of opioids administered within 48 hours after surgery. MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies.

Secondary Outcome Measures

Name	Time	Method
Use of Intravenous Patient-controlled Analgesia	First 48 hours post-operative	The total number of patients that used patient-controlled analgesia within 48 hours after surgery.
Total Length of Hospital Stay	post-operative to discharge	Length of stay was defined as the total number of nights spent in the hospital after surgery.
Number of Participants With Post-operative Ileus	24 hours post-operatively	Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States