Clincosm LogoSign in Get a demo

Intraoperative TAP Block and Post-operative Pain Control for Minimally Invasive Hysterectomy

Sponsor
Tufts Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05763667
Collaborator
(none)
144
Enrollment
1
Location
3
Arms
12
Anticipated Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Modern postoperative pain management aims to optimizing pain relief while minimizing opiate usage. While opiates are effective for pain relief, they result in common adverse effects such as nausea, constipation, and urinary retention, and most importantly present a long-term risk of abuse and dependency [1,2]. Commonly used approaches include non-opiate pain medications such as acetominophen and non-steroidal anti-inflammatory agents, as well as regional nerve blocks such as epidurals [3].

The transversus abdominis plane (TAP) block is a fascial plane block performed by injecting local anesthetic into the plane superficial to the transversus abdominis muscle where the anterior rami of the spinal nerves course to provide sensory innervation to the abdominal wall. The injections are generally placed either subcostally or at the midaxillary line bilaterally [4-6]. The TAP block has been shown to be effective in reducing pain scores and opiate usage in some randomized studies but not others in patients undergoing various abdominal surgeries [7]. There is great variation in method of administration, sites injected, and local anesthetics used, which may in part account for the heterogeneity of trial results.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

We believe that the disappointing results thus far with TAP blocks in minimally invasive hysterectomy may relate to several factors. A combination of short and long-acting anesthetic agents may provide the optimal analgesic effect. Large volumes of injection may promote spread of the anesthetics for better coverage, especially as long-acting agents are known to diffuse minimally. Lastly, multiple injections may provide better coverage of the nerves that innervate the abdominal wall.

We also believe that laparoscopic TAP blocks, administered by the surgeon, have advantages over the more commonly used ultrasound-guided approach typically performed by anesthesiologists [22-24]. The laparoscopic approach is quick, on the order of a few minutes, whereas the ultrasound approach can be time-consuming. There is also less risk of visceral injury since the injection is performed under direct laparoscopic view. There are now 2 randomized studies suggesting that the laparoscopic approach is equivalent to the ultrasound approach [25,26].

An additional potential reason why most studies have been negative is that patients undergoing minimally invasive hysterectomy do not generally experience severe pain, making it more difficult to demonstrate pain reduction with any given intervention. However, the studies to date do indicate that these patients experience moderate pain and do use opiates [15-21]. An intervention that markedly reduces or even eliminates opiate use would be of potential benefit.

We have used a TAP block technique that is performed intraoperatively by the surgeon under direct laparoscopic view. We use a mixture of plain and liposomal bupivacaine injected at multiple sites and in large volume to distribute the drugs widely, potentially resulting in longer and improved efficacy. This method has not been previously studied in a randomized trial. We propose to demonstrate that this technique markedly decreases opiate usage and pain scores in patients undergoing minimally invasive hysterectomy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Potential subjects will be identified in the GYN specialty clinics at Tufts Medical Center and approached for possible study participation. Eligibility criteria will be assessed by the PI or co-I. Eligible subjects who wish to participate in the study will be consented for the study by the PI or co-I. Informed consent for the study may be obtained up to the day of the surgery, prior to anesthesia induction. The following demographics will be collected from the medical record and de-identified: age, race, ethnicity, height, weight, ASA class. On the day of surgery, the subject will be randomized using a random number generator to one of 3 groups: No TAP block TAP block with liposomal and plain bupivacaine: 20 mL liposomal bupivacaine, 30 mL 0.25% bupivacaine, 150 mL normal saline (200 mL total) TAP block with plain bupivacaine alone: 60 mL of 0.25% bupivacaine, 140 mL of normal saline (200 mL total)Potential subjects will be identified in the GYN specialty clinics at Tufts Medical Center and approached for possible study participation. Eligibility criteria will be assessed by the PI or co-I. Eligible subjects who wish to participate in the study will be consented for the study by the PI or co-I. Informed consent for the study may be obtained up to the day of the surgery, prior to anesthesia induction. The following demographics will be collected from the medical record and de-identified: age, race, ethnicity, height, weight, ASA class.On the day of surgery, the subject will be randomized using a random number generator to one of 3 groups:No TAP block TAP block with liposomal and plain bupivacaine: 20 mL liposomal bupivacaine, 30 mL 0.25% bupivacaine, 150 mL normal saline (200 mL total) TAP block with plain bupivacaine alone: 60 mL of 0.25% bupivacaine, 140 mL of normal saline (200 mL total)
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The pharmacy will prepare the solutions for groups 2 and 3, reflecting the usual practice of this PI and his mentees. No solution will be prepared for group 1, as this is a form of standard care for patients undergoing minimally invasive hysterectomy. As the liposomal bupivacaine has a cloudy appearance whereas plain bupivacaine and saline are clear, the surgeon will not be blinded.
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled, Observer-blinded Trial of Laparoscopic Large Volume, Multisite Transversus Abdominal Plane (TAP) Block With Liposomal Bupivacaine in Patients Undergoing Minimally Invasive Hysterectomy.
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: No TAP block
Active Comparator: TAP block with liposomal and plain bupivacaine

Drug: Liposomal bupivacaine
Liposomal bupivacaine is FDA-approved for use single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. The solution will be placed into 20 mL syringes on 18-gauge needles for injection. The injections will be performed percutaneously by the surgeon along the midaxillary line at 4 equidistant points from the anterior superior iliac spine to the costal margin, as well as a single injection subcostally at the anterior axillary line. 20 mL will be injected at each site, 5 sites per side bilaterally, total of 10 sites. The depth of injection will be judged by laparoscopic visualization of a diffuse bulge during injection, indicating injection in the correct plane, just superficial to the transversus abdominis muscle.
Other Names:
  • Exparel

    		•
    Active Comparator: TAP block with plain bupivacaine alone

    Drug: Bupivacain
    Bupivacaine is FDA-approved for use as a local or regional anesthetic for surgery. It is widely used in TAP blocks. The solution will be placed into 20 mL syringes on 18-gauge needles for injection. The injections will be performed percutaneously by the surgeon along the midaxillary line at 4 equidistant points from the anterior superior iliac spine to the costal margin, as well as a single injection subcostally at the anterior axillary line. 20 mL will be injected at each site, 5 sites per side bilaterally, total of 10 sites. The depth of injection will be judged by laparoscopic visualization of a diffuse bulge during injection, indicating injection in the correct plane, just superficial to the transversus abdominis muscle.
    Other Names:
  • Bupivacaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduced opiate use in both TAP block arms. [7 days]

      Demonstrate a statistically significant reduction in postoperative opiate use as measured in oral morphine milligram equivalents on postoperative days 0-7.

    Secondary Outcome Measures

    1. Increase in opiate-free participants by day 7 [7 days]

      Demonstrate an increased proportion of subjects that are opiate-free on postoperative days 0-7.

    2. Reduction in post-operative resting pain scores [7 days]

      Demonstrate a statistically significant reduction in maximum resting numeric rating scale (NRS) at the following time points in postoperative days: 0-1, 1-2, 2-3, 0-7.

    3. Improvement in patient satisfaction regarding pain control [7 days]

      Demonstrate improvement in patient satisfaction with regard to pain control (very satisfied, satisfied, unsatisfied).

    4. Establish safety of the TAP block technique [7 days]

      Establish safety of this technique. Specific AEs measured will be nausea, headache, rash, itching, hematoma, ecchymosis, seizures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age 18-80

    2. Patients undergoing laparoscopic or robotic hysterectomy; may include other procedures (e.g. lymph node removal); for benign or malignant indications

    3. Able to consent to study

    Exclusion Criteria:

    1. Known clinically significant allergy to bupivacaine or liposomal bupivacaine

    2. ASA IV or V

    3. Emergency surgery

    4. Current chronic opiate use

    5. Current pregnancy or breastfeeding

    6. Severe hepatic or renal impairment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tufts Medical Center Boston Massachusetts United States 02111

    Sponsors and Collaborators

    • Tufts Medical Center

    Investigators

    • Principal Investigator: Young B Kim, MD, Tufts Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tufts Medical Center
    ClinicalTrials.gov Identifier:
    NCT05763667
    Other Study ID Numbers:
    • STUDY00003529
    First Posted:
    Mar 10, 2023
    Last Update Posted:
    Mar 10, 2023
    Last Verified:
    Feb 1, 2023
    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
    Keywords provided by Tufts Medical Center
    hysterectomy
    minimally invasive surgery
    TAP block
    Additional relevant MeSH terms:
    Pain, Postoperative
    Bupivacaine

    Study Results

    No Results Posted as of Mar 10, 2023