Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02356198
• Collaborator: (none)
• Enrollment: 209
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Conditions Requiring Colorectal Surgery	Drug: EXPAREL; Drug: Intrathecal hydromorphone	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 209 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery: A Prospective Randomized Trial
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TAP block (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.	Drug: EXPAREL; transversus abdominis plane injection; Other Names: liposomal bupivacaine
Active Comparator: Intrathecal opioid (IT) single injection intrathecal hydromorphone analgesia given preoperatively	Drug: Intrathecal hydromorphone; Intrathecal opioid administration; Other Names: dilaudid

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Dorin Colibaseanu, MD, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 2, 2017

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Dorin T. Colibaseanu, M.D., PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02356198
• Other Study ID Numbers: 14-003143
• First Posted: Feb 5, 2015
• Last Update Posted: Mar 7, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Hydromorphone; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	TAP Block (EXPAREL)	Intrathecal Opioid (IT)
Arm/Group Description	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. EXPAREL: transversus abdominis plane injection	single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration
Period Title: Overall Study
STARTED	104	105
COMPLETED	102	98
NOT COMPLETED	2	7

Baseline Characteristics

Arm/Group Title	TAP Block (EXPAREL)	Intrathecal Opioid (IT)	Total
Arm/Group Description	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. EXPAREL: transversus abdominis plane injection	single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration	Total of all reporting groups
Overall Participants	102	98	200
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	61	58	60
Sex: Female, Male (Count of Participants)
Female	45 44.1%	43 43.9%	88 44%
Male	57 55.9%	55 56.1%	112 56%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	102 100%	98 100%	200 100%

Outcome Measures

1. Primary Outcome

Title	Mean Pain Score
Description	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.
Time Frame	First 48 hours post operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block (EXPAREL)	Intrathecal Opioid (IT)
Arm/Group Description	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. EXPAREL: transversus abdominis plane injection	single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration
Measure Participants	102	98
Mean (95% Confidence Interval) [score on a scale]	3.0	2.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAP Block (EXPAREL), Intrathecal Opioid (IT)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Total Morphine Milligram Equivalents Use (MME)
Description	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.
Time Frame	First 48 hours post operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block (EXPAREL)	Intrathecal Opioid (IT)
Arm/Group Description	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. EXPAREL: transversus abdominis plane injection	single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration
Measure Participants	102	98
Median (95% Confidence Interval) [total morphine milligram equivalents]	47.5	32.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAP Block (EXPAREL), Intrathecal Opioid (IT)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.102
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Total Length of Hospital Stay
Description	Length of stay was defined as the total number of nights spent in the hospital after surgery.
Time Frame	post-operative to discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block (EXPAREL)	Intrathecal Opioid (IT)
Arm/Group Description	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. EXPAREL: transversus abdominis plane injection	single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration
Measure Participants	102	98
Median (95% Confidence Interval) [nights]	3	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAP Block (EXPAREL), Intrathecal Opioid (IT)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Number of Participants With Post-operative Ileus
Description	Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery.
Time Frame	24 hours post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block (EXPAREL)	Intrathecal Opioid (IT)
Arm/Group Description	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. EXPAREL: transversus abdominis plane injection	single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration
Measure Participants	102	98
Count of Participants [Participants]	11 10.8%	14 14.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAP Block (EXPAREL), Intrathecal Opioid (IT)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.454
	Comments
	Method	Chi-squared
	Comments

5. Secondary Outcome

Title	Use of Intravenous Patient-controlled Analgesia
Description	The total number of patients that used patient-controlled analgesia within 48 hours after surgery.
Time Frame	First 48 hours post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block (EXPAREL)	Intrathecal Opioid (IT)
Arm/Group Description	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. EXPAREL: transversus abdominis plane injection	single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration
Measure Participants	102	98
Count of Participants [Participants]	5 4.9%	1 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAP Block (EXPAREL), Intrathecal Opioid (IT)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.212
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Time Frame	The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
Arm/Group Title	TAP Block (EXPAREL)		Intrathecal Opioid (IT)
Arm/Group Description	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. EXPAREL: transversus abdominis plane injection		single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration
All Cause Mortality
	TAP Block (EXPAREL)		Intrathecal Opioid (IT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/102 (0%)		0/98 (0%)
Serious Adverse Events
	TAP Block (EXPAREL)		Intrathecal Opioid (IT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/102 (3.9%)		4/98 (4.1%)
Blood and lymphatic system disorders
Bleeding at injection site	0/102 (0%)	0	1/98 (1%)	1
Cardiac disorders
Myocardial infarction	0/102 (0%)	0	1/98 (1%)	1
Gastrointestinal disorders
Intra-abdominal abscess	1/102 (1%)	1	0/98 (0%)	0
Anastomosis leakage	1/102 (1%)	1	0/98 (0%)	0
Infections and infestations
Peristomal wound infection	0/102 (0%)	0	1/98 (1%)	1
Nervous system disorders
Spinal fluid leakage	0/102 (0%)	0	1/98 (1%)	1
Renal and urinary disorders
Acute kidney injury	1/102 (1%)	1	0/98 (0%)	0
Respiratory, thoracic and mediastinal disorders
Tachypnea with hypoxia	1/102 (1%)	1	0/98 (0%)	0
Other (Not Including Serious) Adverse Events
	TAP Block (EXPAREL)		Intrathecal Opioid (IT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/102 (0%)		0/98 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.