Pilot: Intraoperative TAP Block and Post-operative Pain Control for Minimally Invasive Hysterectomy for Endometrial Cancer
NCT ID: NCT05763667
Last Updated: 2025-04-24
Study Results
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Basic Information
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COMPLETED
PHASE3
15 participants
INTERVENTIONAL
2024-01-01
2024-09-09
Brief Summary
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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. 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. 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.
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Detailed Description
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The investigators also believe that laparoscopic TAP blocks, administered by the surgeon, have advantages over the more commonly used ultrasound-guided approach typically performed by anesthesiologists. 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.
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. An intervention that markedly reduces or even eliminates opiate use would be of potential benefit.
The investigators have used a TAP block technique that is performed intraoperatively by the surgeon under direct laparoscopic view. The investigators 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. The investigators propose to demonstrate that this technique markedly decreases opiate usage and pain scores in patients undergoing minimally invasive hysterectomy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
On the day of surgery, the subject will be randomized using a random number generator to one of 3 groups:
1. No TAP block
2. TAP block with liposomal and plain bupivacaine: 20 mL liposomal bupivacaine, 30 mL 0.25% bupivacaine, 150 mL normal saline (200 mL total)
3. TAP block with plain bupivacaine alone: 60 mL of 0.25% bupivacaine, 140 mL of normal saline (200 mL total)
TREATMENT
DOUBLE
Study Groups
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No TAP block
No interventions assigned to this group
TAP block with liposomal and plain bupivacaine
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.
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.
TAP block with plain bupivacaine alone
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients undergoing laparoscopic or robotic hysterectomy; may include other procedures (e.g. lymph node removal)
3. Endometrial cancer or endometrial intraepithelial neoplasia
4. Able to consent to study
Exclusion Criteria
2. ASA IV or V
3. Emergency surgery
4. Current chronic opiate use
5. Current pregnancy or breastfeeding
6. Severe hepatic or renal impairment
7. Hysterectomy is not for endometrial cancer or endometrial intraepithelial neoplasia
18 Years
80 Years
FEMALE
No
Sponsors
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Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Young B Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Countries
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References
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Other Identifiers
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Pending
Identifier Type: -
Identifier Source: org_study_id
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