Symptoms and General Pathology

All Conditions

Neoplasms

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

Central Nervous System Depressants

All Drugs and Chemicals

Bupivacaine

Anesthetics

Anesthetics, Local

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).

Bupivacain

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

Anti-Arrhythmia Agents

Channel Blockers

Analgesics

Lidocaine

Morphine

Analgesics, Opioid

Sodium Channel Blockers

Diuretics, Potassium Sparing

Patients will also undergo a loading dose of lidocaine, followed by continuous lidocaine infusion in the lidocaine group.

Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively.

Patients will undergo a simulated QL block.

Patients will undergo a posterior QL block.

Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively.

Patients will receive a saline bolus infusion.

Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively.

Patients will undergo a simulated QL block.

Patients will receive a saline bolus infusion.

Patients will undergo Lidocaine Bolus infusion.

Lidocaine Bolus Infusion

Patients will undergo a posterior QL block pre-operatively

QL block

Patients will undergo Saline Bolus infusion.

Saline Bolus Infusion

Patients will undergo a simulated posterior QL block pre-operatively.

Simulated QL block

Prentiss Lawson, MD

This study may provide evidence for whether or not systemic lidocaine infusion offers significant advantage over truncal regional blocks in gynecology oncology surgery patients in terms of post-operative analgesia, recovery, and safety profile. Further, it may show whether there is any increased efficacy of adding truncal regional block or systemic lidocaine versus intrathecal opioid administration alone.

Systemic administration of intravenous lidocaine has a number of observed and theoretical advantages in the perioperative period. Systematic review of perioperative lidocaine infusions has shown a reduction in early post-operative pain scores in patients undergoing abdominal surgery, positive effects for GI recovery, reduction in post-operative opioid requirements, reduction in the incidence of post-operative nausea and vomiting, and decreased length of hospital stay. They have been shown to modulate the surgery-induced stress response in colorectal surgery and abdominal hysterectomy. Thoracic epidural analgesia was better as compared to intravenous lidocaine in a RCT of patients undergoing laparoscopic colorectal surgery as part of an enhanced recovery program, though there was similar impact on recovery of bowel function.

Truncal regional anesthesia has been utilized in open and closed abdominal operations with various levels of efficacy. A statistically significant, though marginal clinical analgesic benefit, by recorded opioid consumption, has been concluded by meta-analysis in patients undergoing abdominal laparotomy, laparoscopy, or cesarean delivery after US-guided TAP block. There was not found to be any additional benefit of TAP block in patients who received a spinal anesthetic that included a long-acting opioid. The interpretation of results was noted to be limited by the heterogeneity of the included studies and analysis, though. The conclusions of one study of open prostatectomy, as part of an ERP, was that neither systemic lidocaine nor TAP block improved post-operative analgesia. Both IV lidocaine and TAP block groups showed a reduction in post-operative opioid consumption, though to an insignificant degree. It was noted as a possibility that the other interventions as part of the ERP, such as scheduled administration of IV acetaminophen, could have resulted in the non-significant decrease in post-operative opioid requirement. A recent review of the use of TAP blocks in major gynecological, non-obstetric, surgery, including total abdominal hysterectomy, concluded that TAP blocks may contribute to early post-operative analgesia, with marginal additional benefit if multimodal analgesic regimens including NSAIDs and acetaminophen are added. It was hypothesized by the authors that some of the limited benefit might be due to the fact that US-guided TAP blocks are primarily useful for somatic pain, but that major gynecologic surgery has a large visceral pain component. There are limited randomized studies involving Quadratus Lumborum block (QL) at this time. QL block has shown improved analgesia in abdominal operations as compared to TAP block and is thought to have potentially greater relief of visceral pain. There is a case report of motor weakness following anterior, lateral QL block for gynecologic laparoscopy, thought to be related to spread of the block to affect the L2 dermatome on one side. It has not been determined if this is a common occurrence or may be affected by the type of QL block performed.

Prior to this study, truncal regional anesthesia was used in the UAB Gynecology-Oncology Surgery Enhanced Recovery Program as an analgesic alternative for those who were not good candidates for intrathecal opioid injection. A comparison of QL block versus systemic lidocaine infusion or whether either of these interventions has utility over intrathecal opioid administration alone has yet to be described.

Eligible patients will undergo current standard enhanced recovery protocol (ERP) gyn-oncology protocol. All patients will receive intrathecal morphine as part of the existing ERP. They will then be randomized to receive; either lidocaine infusion, regional anesthesia truncal block (quadratus lumborum block), or intrathecal morphine alone. Patients will be randomized into either lidocaine (group 1), QL block (group 2), or intrathecal opioid alone (group 3) groups. There will be blinding of the patient and personnel involved in data collection, and patients will undergo either a posterior QL block with local anesthetic (group 2) or simulated QL block (groups 1 and 3; subcutaneous local anesthetic only) pre-operatively. All patients will also undergo a loading dose of lidocaine (groups 1) or saline (group 2 and 3) followed by continuous lidocaine infusion in the lidocaine group (group 1). Primary and secondary endpoints will be measured post-operatively.

Participant eligibility is based on biological gender identity.

Lidocaine Infusion or Quadratus Lumborum Block and Intrathecal Morphine, Versus Intrathecal Morphine Alone

Systemic Lidocaine Infusion or Quadratus Lumborum Block (in Addition to Intrathecal Morphine) Versus Intrathecal Morphine Alone as Part of a Gynecology-Oncology Surgery Early Recovery Protocol

Total opioid consumption (measured in oral morphine equivalents)

This outcome measure will reflect the total amount of time required for the patient to be deemed suitable for discharge from the PACU, starting from the time of admittance to the PACU.

This score will be collected using the modified Aldrete scale, every 15 minutes for the first hour of PACU stay, and once per hour for any additional hour(s) of PACU stay using a method consisting of: Consciousness = fully awake (2 points), arousable (1 point), not responding (0 points). This scale is used to determine a participant's state of arousal. The range of the scale is from 0-2, with zero being the most unresponsive and two being the most responsive.

Number of minutes spent ambulating, per subject and/or nurse reporting

Return to bowel function (return of flatus, BM, ability to tolerate PO), per subject and/or nurse reporting

likely expressed as mcg of fentanyl but may be converted to morphine equivalent dose if multiple opioids are used

Whether or not a PCA is needed for post-operative analgesia (Y/N - per usual documentation in the EMR.

time from admission to the floor to administration of first opioid medication (per usual nursing documentation in the EMR).

This outcome will be measured by taking the average of the numerical pain scale used to assess a patient's pain levels throughout their time in the PACU. The numerical pain scale has a range of 0 to 10, with 0 being no pain and 10 being very severe pain.

This outcome will be measured by taking the value of the numerical pain scale used to assess a patient's pain levels throughout their time in the hospital that is closest to each 4 hours after the time of the anesthesia documentation finish

Average total amount of opioids consumed in the PACU

Post-operative opioid consumption (measured in oral morphine equivalents)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Lidocaine Infusion or Quadratus Lumborum Block and Intrathecal Morphine, Versus Intrathecal Morphine Alone	NCT03658109	Gynecologic Can...	Lidocaine Bolus... QL block Saline Bolus In... Simulated QL bl...	18 Years - 69 Years	University of Alabama at Birmingham

Spots Global Cancer Trial Database for ql block

Every month we try and update this database with for ql block 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 ql block

Every month we try and update this database with for ql block 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 ql block 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.