TAP Block Using Liposomal Bupivacaine for Post-cesarean Delivery Analgesia- Walking Towards Recovery

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04393207
Collaborator
(none)
200
Enrollment
1
Location
3
Arms
24.9
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The TAP block offers analgesia by blocking the sensory nerves of the anterior abdominal wall. The procedure is performed under ultrasound guidance, after identification of the external oblique, internal oblique and transverse abdominis muscle. Medication is injected in the neurofascial plane between the internal oblique and the tranversus abdominis muscle.

Previous studies have demonstrated limited (<24 hour) effect of the block when compared to the use of intrathecal morphine (considered to be the "gold standard" for postoperative analgesia). In a study by McMarrow et al., post-caesarian pain control combinations including TAP blocks with local anesthetic (Bupivacaine) or saline after a spinal anesthetic with or without intrathecal morphine were compared.

At 6 hours the Morphine consumption was slightly reduced in the patients that received both intrathecal morphine and TAP blocks with LA when compared to patients that received spinal saline and TAP with saline. At 24 hours the TAP block conferred no benefit in terms of opioid consumption. Similarly, the study by Lee et al. demonstrated better pain scores for the first 2 hours in patients receiving both intrathecal morphine and a TAP block with ropivacaine. At 24 hours there was no difference in the pain scores for patients that received both intrathecal morphine and TAP blocks.

On the contrary, a more recent study utilizing liposomal bupivacaine has been utilized for TAP blocks for post cesarean delivery analgesia, demonstrating opioid reductions for up to 72 hours. Liposomal bupivacaine is a novel, multivesicular formulation designed for rapid absorption, prolonged release of bupivacaine, and analgesia following a single intra-operative administration into the surgical wound or for TAP blocks.

Current anesthesia practices encourage the use of multimodal analgesia that aim at enhanced recovery after surgery (ERAS). The ERAS model aims to decrease immobility, pain and post-operative ileus. Pain and immobility may be closely related, and the latter has rarely been monitored in the post-operative setting. It is planned to use a research validated fit-bit like device (Actigraph GT3-X) to monitor patient steps (mobility).

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Detailed Description

This is a double blinded, randomized controlled trial. The study will be composed of 3 groups Group 1- Transverse abdominus plain block with liposomal bupivacaine + bupivacaine (LB) Group 2 - Transverse abdominus plain block with bupivacaine (BP) Group 3 - Control group (standard of care with no TAP)

  1. Patients will be asked to participate after meeting their anesthesia team and giving verbal consent to receive spinal anesthesia for their cesarean delivery.

  2. A computer-generated, single block randomization scheme will be used to allocate patients to one of the three groups (Control group Vs TAP LB group or BP group).

  3. In the OR, a spinal using 10-12 mg bupivacaine 0.75%, 10 mcg Fentanyl and 0.1 mg preservative free intrathecal morphine will be performed. Patients will receive IV acetaminophen 1 gram, before skin incision and ketorolac 30 mg after closure of fascia. All patients will receive the same postoperative analgesia orders, which include Tylenol, Ibuprofen and opioids for breakthrough pain. (standard of care)

After wound closure a TAP block will be performed according to randomization process as described above.

  1. The LB TAP block group will receive bilateral ultrasound guided block utilizing 10 ml of liposomal bupivacaine* and 20 ml of 0.25% bupivacaine. The BP TAP group will receive bilateral ultrasound guided block utilizing 20 ml of 0.25% bupivacaine.(Research procedure)

  2. The control group will be approached in the exact same way the TAP block group, that is, the ultrasound would be used to identify the muscle layer, but a covered needle will be used to simulate a TAP block. The randomization and procedure will be handled by a co-investigator not involved in the evaluation or data collection at the stablished time points. Patients will be recruited from 7am-5pm and for elective CD

  3. Once in the recovery room, the parturient will be asked to wear a fit-bit device (Actigraph Gt3X). The device would measure steps taken for a period of 72 hours, as an objective marker of mobility. (Research procedure)

  4. Patients will be asked to complete the ObsQoR-11 at 24 hours, 48 hours and 72 hours.

All patients in this study will be receiving the standard of care. The current standard of care is spinal anesthesia inclusive of intrathecal morphine.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Transverse Abdominis Plane Block Using Liposomal Bupivacaine for Post-operative Cesarean Delivery Analgesia- Walking Towards Recovery
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Sham Comparator: Control group

Patient will receive intrathecal morphine and a Sham TAP block.

Other: Control group
Sham block will be performed

Experimental: Liposomal Bupivacaine

Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%

Drug: Liposomal bupivacaine
Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with liposomal bupivacaine + bupivacaine or with bupivacaine alone.
Other Names:
  • Exparel
  • Drug: Bupivacaine
    ransverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
    Other Names:
  • Sensorcaine, Marcaine
  • Active Comparator: Bupivacaine

    Patient will receive intrathecal morphine + TAP block with only bupivacaine.

    Drug: Bupivacaine
    ransverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
    Other Names:
  • Sensorcaine, Marcaine
  • Outcome Measures

    Primary Outcome Measures

    1. MME [24 hours]

      Morphine milligram equivalents

    2. MME [48 hours]

      Morphine milligram equivalents

    3. MME [72 hours]

      Morphine milligram equivalents

    Secondary Outcome Measures

    1. Assessment of functional recovery [6 hours]

      Number of steps after delivery

    2. Assessment of functional recovery [12 hours]

      Number of steps after delivery

    3. Assessment of functional recovery [24 hours]

      Number of steps after delivery

    4. Assessment of functional recovery [36 hours]

      Number of steps after delivery

    5. Assessment of functional recovery [48 hours]

      Number of steps after delivery

    Other Outcome Measures

    1. Self assessed recovery survey [24 hours]

      Use of a validated questionnaire to measure recovery after cesarean delivery ObsQoR-11

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Patients between the ages of 18 and 45 presenting for cesarean delivery

    2. ASA-1, ASA-2, ASA-3

    3. No allergy to morphine

    4. No allergy to bupivacaine

    5. Patients with BMI > 45 will be excluded

    6. No history of anxiety

    7. No recent or chronic opioid use

    Exclusion Criteria:
    1. Need for Magnesium sulfate therapy

    2. Neonatal admission to neonatal intensive care unit

    3. Need for additional surgery other than cesarean delivery +/- bilateral tubal ligation (e.g. hysterectomy, cystotomy)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Yale UniversityNew HavenConnecticutUnited States06510

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: Antonio Gonzalez, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT04393207
    Other Study ID Numbers:
    • 2000027606
    First Posted:
    May 19, 2020
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2021