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Completed

NCT Number: NCT04781075

Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery

Single Blind, Randomized Controlled study to see if TAP Block with Exparel provides better pain relief than TAP Block with bupivicaine. Differences in Pain Scale, Length of Stay, and Total Narcotic use in the hospital will be evaluated.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

About this study

Subjects recruited into the study will undergo surgery as scheduled. During the procedure they will receive a TAP Block with one of the pain medications. TAP Block in the experimental arm will be performed with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline. The control arm will have a TAP Block performed with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline. These doses are consistent with prior studies of TAP Block with liposomal bupivacaine. Subjects will be monitored for pain as per standard of care and will be given pain medication as needed.

Subject Recruitment and Screening Patients will be recruited from the Ochsner Colorectal Surgery Clinic at the time of a preoperative visit.

Study Procedures

Screening & Baseline Visit After obtaining informed consent the subjects relevant medical and surgical history will be documented. Demographics and vitals will be documented. Current use of pain medication will be recorded. A physical exam will be performed.

Day of Surgery Routine vital signs will be obtained preoperatively. During the operation subject will receive a TAP Block containing their randomized local injection mixture as described above. Following surgery the subject will recover the PACU and pain medication will be provided on demand. Initial postoperative vital signs and pain scores will be obtained at this time.

Post-Operative Course Postoperatively subject will have regularly scheduled vital signs and pain scores obtained, and recorded for study use. Narcotic and non-narcotic pain medication will be provided on demand; dosages will be recorded for study use. Subjects will be followed until they are discharged at which time study participation will be complete.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients age 18-75 years undergoing planned laparoscopic colon or rectal resection

Exclusion criteria

  • Patients younger than 18 or older than 75 years old
  • Pregnant women
  • Patients who have taken steroids or other immunomodulators within the last 6 months
  • Patients on home narcotics
  • Patients allergic to Exparel or bupivacaine

Treatment and study plan

pain scale

Other

Maximum Daily Pain Scale will be recorded daily until discharge (typically under 7 days)

Exparel Injectable Product

Drug

Given at the beginning of the surgery for post-operative pain management

Bupivacaine Injection

Drug

Given at the beginning of the surgery for post-operative pain management

Primary outcomes

  1. Pain Scale

    Time frame: daily through study completion (up to 30 days)

    Daily Pain Scale using Wong-baker FACES Pain Rating Scale 0 (no pain) - 10 (worst pain imaginable)

Secondary outcomes

  1. Length of stay

    Time frame: daily through study completion (up to 30 days)

    Duration of hospitalization post-operatively

  2. Narcotic use

    Time frame: daily through study completion (up to 30 days)

    Total amount of narcotic used for pain control postoperatively

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Registry information

Official study title

TAP (Transverse Abdominis Plane) Block With Exparel (Liposomal Bupivicaine) vs. Bupivicaine Post-op Pain Management

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 4, 2021
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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