Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Bupivacaine

Dexmedetomidine

Anesthetics

Anesthetics, Local

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Ultrasonography (USG) guided bilateral TAP block:20 ml %0,25 concentration bupivacain

Ultrasonography (USG) guided bilateral TAP block: 20 ml %0,25 concentration bupivacain+ 0.5 mcg/kg dexmedetomidine

Ultrasonography (USG) guided bilateralTAP block:20 ml %0,25 concentration bupivacain

Bupivacain

bupivacain+dexmedetomidine

Beyza Seker, MD

Hazal E Guran Aytug, MD

Transversus abdominis plane (TAP) block is an anesthesia method that provides somatic analgesia to the anterior and lateral abdominal walls. Thus, TAP block is widely implemented in perioperative management of colorectal cancer patients.

Researchers aimed to evaluate the analgesic effectiveness and duration of effect of dexmedetomidine added to bupivacaine in the TAP block applied in colorectal cancer surgeries.

Transversus abdominis plane (TAP) block is an anesthesia method that provides somatic analgesia to the anterior and lateral abdominal walls. With the increasing use of ultrasound guidance during peripheral nerve blocks, trunk blocks such as the transversus abdominis plane (TAP) block are widely used for analgesia after abdominal surgery.

The advantages of TAP block include being less invasive than epidural analgesia, lower incidence of hypotension, and shorter hospital stay. Due to these advantages, TAP block has become a widely preferred method.

Researchers aimed to evaluate the analgesic effectiveness and duration of effect of dexmedetomidine added to bupivacaine in the TAP block applied in colorectal cancer surgeries. The study will be conducted in a tertiary oncology hospital in Turkey and 84 colorectal cancer patients will be included.

The Effectiveness of Bupivacaine and Bupivacaine+Dexmedetomidine Combination in Transversus Abdominis Plane* Block

Comparison of the Effectiveness of Bupivacaine and Bupivacaine+Dexmedetomidine Combination in Transversus Abdominis Plane* Block in Colorectal Cancer Surgery

Numeric Rating Scales of two groups in postoperative period. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Resident Anaesthesiologist

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Nervous System Diseases

Pain, Postoperative

Leiomyoma

Myofibroma

Pain

Postoperative Complications

Neurologic Manifestations

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).

Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).

30cc IM injection in each quadratus lumborum muscle (60cc total).

Saline

Catherine P Haering, BA

Joseph Findley, MD

This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is becoming a standard of anesthesia and surgical care. Since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. The investigators will be comparing patients who receive the QL block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the QL block (in addition to standard care). The participants will be randomly assigned to one of the two groups and may or may not actually receive the block.

QL Block in Laparoscopic Myomectomy

Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.

RASS is measured from -5 to +4 with -5 being no response to voice or physical stimulation and +4 being overtly combative, violent, immediate danger to staff

VAS is a pain scale from 0-10 with 0 being no pain and 10 being the worst pain ever.

Pain management scale with 1 being very disappointed in pain management with 10 being highly satisfied with pain managment.

Joseph Findley MD

University Hospitals Department of Reproductive Endocrinology and Infertility

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Pharmaceutical Solutions

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.

Liposomal bupivacaine

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.

Young B Kim, MD

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. 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.

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.

The investigators 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.

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.

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:

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)

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.

Pilot: Intraoperative TAP Block and Post-operative Pain Control for Minimally Invasive Hysterectomy for Endometrial Cancer

A Randomized, Controlled, Observer-blinded Pilot Trial of Laparoscopic Large Volume, Multisite Transversus Abdominal Plane (TAP) Block With Liposomal Bupivacaine in Patients Undergoing Minimally Invasive Hysterectomy for Endometrial Cancer

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

Demonstrate a change in proportion of subjects that are opiate-free on postoperative days 0-7.

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

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

Specific AEs measured will be nausea, headache, rash, itching, hematoma, ecchymosis, seizures

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effectiveness of Bupivacaine and Bupivacaine+Dexmedetomidine Combination in Transversus Abdominis Plane* Block	NCT06370949	Colorectal Canc... Colorectal Neop...	Bupivacain bupivacain+dexm...	18 Years - 65 Years	Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
QL Block in Laparoscopic Myomectomy	NCT05979493	Postoperative P... Fibroid Uterus	Bupivacain Saline	18 Years - 45 Years	University Hospitals Cleveland Medical Center
QL Block in Laparoscopic Myomectomy	NCT05979493	Postoperative P... Fibroid Uterus	Bupivacain Saline	18 Years - 45 Years	University Hospitals Cleveland Medical Center
The Effectiveness of Bupivacaine and Bupivacaine+Dexmedetomidine Combination in Transversus Abdominis Plane* Block	NCT06370949	Colorectal Canc... Colorectal Neop...	Bupivacain bupivacain+dexm...	18 Years - 65 Years	Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Pilot: Intraoperative TAP Block and Post-operative Pain Control for Minimally Invasive Hysterectomy for Endometrial Cancer	NCT05763667	Post Operative ... Gynecologic Can...	Liposomal bupiv... Bupivacain	18 Years - 80 Years	Tufts Medical Center
Pilot: Intraoperative TAP Block and Post-operative Pain Control for Minimally Invasive Hysterectomy for Endometrial Cancer	NCT05763667	Post Operative ... Gynecologic Can...	Liposomal bupiv... Bupivacain	18 Years - 80 Years	Tufts Medical Center

Spots Global Cancer Trial Database for bupivacain

Every month we try and update this database with for bupivacain cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bupivacain

Every month we try and update this database with for bupivacain cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bupivacain cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.