Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine

Pain, Postoperative Clinical Trial

Official title:

Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996227
• Other study ID #: 16-1449 -EXPLANE Block
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: October 2019

Study information

• Verified date: January 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine

Description:

The investigator goal is to compare the analgesic efficacy of TAP blocks with liposomal bupivacaine (Exparel) and continuous epidural blocks in patients who are scheduled for major lower abdominal surgery. To assess whether TAP block with Exparel is noninferior to continuous epidural analgesia on pain management, defined as noninferior for both pain control and total opioid consumption for 72 hours, in patients who had major lower abdominal surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: October 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• 18-85 years old

• ASA Physical Status 1-3

• Scheduled for elective open or laparoscopic abdominal surgery, including colorectal and hysterectomy surgeries

• Anticipated hospitalization of three nights

• Expected requirement for parenteral opioids for at least 72 hours for postoperative pain

• Able to use IV PCA systems.

Exclusion Criteria:

• Hepatic disease, e.g. twice the normal levels of liver enzymes

• Kidney disease, e.g. twice the normal level of serum creatinine

• Bupivacaine sensitivity or known allergy

• Women who are pregnant or breastfeeding

• Anticoagulants considered to be a contraindication for epidural or TAP blocks.

• Surgeries with high port sites will be excluded

Related Conditions & MeSH terms

• Major Abdominal Surgery
• Pain, Postoperative

Intervention

Procedure:
• TAP block
Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.
• Epidural analgesia
Epidural catheters will be inserted preoperatively.

Drug:
• EXPAREL
Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.
• Bupivacaine
Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of Hypoxemia	ViSi mobile (Sotera Wireless) patient monitoring system will be used to obtain vital signs including SpO2 of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. The outcome is area-under-the-curve for saturation over time with the threshold set at 90%.	Data was recorded at 15-s intervals during the initial 72 postoperative hours.
Other	Persistent Postoperative Incisional Pain- MBPI Pain Intensity	Defined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = "no pain" and 10 = "pain as bad as you can imagine."; and for interference items, 0 = "does not interfere" and 10 = "interferes completely." The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely).	At the 90-day follow up
Other	Persistent Postoperative Incisional Pain- MBPI Pain Interference	Defined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = "no pain" and 10 = "pain as bad as you can imagine."; and for interference items, 0 = "does not interfere" and 10 = "interferes completely." The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely).	At the 90-day follow up
Primary	VRS Pain Score	Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced. The VRS will be recorded every 4 hours for 72 hours after discharge from the PACU. Summary statistics of pain scores are reported as means ± standard deviations of average pain during the first 72 postoperative hours	The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.
Primary	Total Opioid Consumption	Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery.	During the 72 hours after discharge from the PACU.
Secondary	Cumulative Duration of Activity	defined as the total duration of time patients spent sitting or standing, as determined by the mobile monitoring system during the initial 72 postoperative hours.	During the initial 72 postoperative hours.
Secondary	Opioid-related Side Effect	We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate the frequency, severity, and bothersomeness of: nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating,drowsiness or difficulty staying awake, feeling lightheaded or dizzy,feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth, and headache. Severity: 1=Slightly severe 2=Moderately severe 3=Severe 4=Very severe; Frequency: 1=Rarely 2=Occasionally 3=Frequently 4=Almost constantly; Bothersomeness (rescaled to a 4-point scale): 0.8=not at all 1.6=a little bit 2.4= somewhat 3.2=quite a bit 4.0=very much. If a patient did not experience the symptom in the past 24 hours, a score of 0 was assigned to each domain. Opioid-related side effect is the sum of the patient's frequency, severity, and bothersomeness, scored from 0 to 12. Higher scores indicate greater severity.	The first, second and third postoperative mornings
Secondary	Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.	Visi mobile patient monitoring system will be used to obtain the blood pressure of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. We re-defined postoperative hypotension as any MAP <65 mmHg, because few patients experienced such profound hypotension as originally planned and because papers published since the trial were designed to identify 65 mmHg as the harm threshold for both myocardial and renal injury. Summary statistics of hemodynamic instability are reported as means ± standard deviations of average MAP during the first 72 postoperative hours.	Data was recorded at 15-s intervals during the initial 72 postoperative hours.
Secondary	Quality of Recovery After Anesthesia	Quality of recovery (QoR) will be measured using QoR-15 questionnaire which includes 15 11-point numerical rating scale. For positive items, 0 = "none of the time [poor]" to 10 = "all of the time [excellent]"; Conversely, for negative items, 10 = "none of the time [excellent]" to 0 = "all of the time [poor]". Quality of recovery is the sum of all the 15 questions, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR).	The first and third postoperative mornings
Secondary	Length of Hospital Stay	The length of hospital stay will be measured as days.	From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks