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Female Urogenital Diseases and Pregnancy Complications

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Levobupivacaine

Tramadol

Ketoprofen

In the first group, patients will receive intravenous, systemic, multimodal analgesia: paracetamol 1 gram and ketoprofen 100 mg every 8 hours for 24 hours. Analgesia will start immediately after surgery. If the pain persists, the patient will be given "rescue" analgesia: tramadol 50 mg intravenously up to a maximum dose of 400 mg / 24 h and other analgesics if needed.

In the second group there will be patients in who will be given the TAP block. The TAP block will be given postoperatively before waking. It will be given bilaterally in the before mentioned anatomic region (the so-called lateral TAP block) of 0.25% levobupivacaine in 40 ml bilaterally. If such analgesia is not satisfactory, tramadol 50 mg intravenously, up to a maximum dose of 400 mg / 24h, and other analgesics will be given at the request of the patient.

In the third group there will be patients who will be treated with TAP block in addition to systemic, mutimodal analgesia. If such analgesia is not satisfactory, tramadol 50 mg intravenously, up to a maximum dose of 400 mg / 24h, and other analgesics will be given at the request of the patient.

Paracetamol 1 gram and ketoprofen 100 mg every 8 hours for 24 hours. Analgesia will start immediately after surgery. If the pain persists, the patient will be given "rescue" analgesia: tramadol 50 mg intravenously up to a maximum dose of 400 mg / 24 h and other analgesics if needed.

Systemic multimodal analgesia administered intravenously

The TAP block will be given postoperatively before waking. It will be given bilaterally in the before mentioned anatomic region (the so-called lateral TAP block) of 0.25% levobupivacin in 40 ml bilaterally. If the pain persists, the patient will be given "rescue" analgesia: tramadol 50 mg intravenously up to a maximum dose of 400 mg / 24 h and other analgesics if needed.

Transversus abdominis plane block (TAP block)

TAP block in addition to systemic, mutimodal analgesia. If such analgesia is not satisfactory, tramadol 50 mg intravenously, up to a maximum dose of 400 mg / 24h, and other analgesics will be given at the request of the patient.

Combined transversus abdominis plane block (TAP block) with systemic multimodal analgesia administered intravenously

Dean Markić, MD, PHD, Prof.

Ivana Miletović, MD

Irena Hrstić, MD,PHD, Assoc. Prof.

Herman Haller, PHD, MD, prof.

Ines Krištofić, MD

Tomislav Perkov, MD

This study evaluates the influence of the transversus abdominis plane block on the intensity of postoperative pain and the concentration of proinflammatory and pain factors after hysterectomy by laparotomy. The patients will be randomized in three groups.In the first group, patients will receive intravenous, systemic, multimodal analgesia.In the second group there will be patients in who will be given the TAP block. The TAP block will be given postoperatively before waking. It will be given bilaterally in the before mentioned anatomic region (the so-called lateral TAP block). In the third group there will be patients who will be treated with TAP block in addition to systemic, mutimodal analgesia. The research will be based on completing a questionnaire (VAS scale and QoR questionnaire) and taking peripheral blood out. We expect that the concentration of proinflammatory and pain factors in patients treated with a TAP block will be lower and the quality of recovery will be better than that of patients receiving standard analgesic therapy (systemic multimodal analgesia).

The influence of the transversus abdominis plane block on the intensity of postoperative pain and the concentration of proinflammatory and pain factors after laparotomy for gynecological procedures

Showing the problem

Hysterectomy is one of the most commonly performed surgical operations. Indications for hysterectomy are numerous and include benign and malignant etiology. Symptomatic leiomyomas, pelvic organ prolapse, abnormal uterine bleeding, endometriosis, chronic pain, and premalignant lesions are the most commonly benign indications for hysterectomy. The uterus can be removed using an abdominal, vaginal or laparoscopic approach. Each of these approaches is related to postoperative pain as well as on an increase in inflammatory factors that may adversely affect the recovery of patients. Therefore, pain management has become one of the major quality of life issues in the postoperative period. Post-operative pain is not only a limitation for the patient but the long-term pain can have deleterious effects on respiratory, cardiocirculatory and neuroendocrine function. Adverse physiological changes due to inadequate or insufficient postoperative analgesia can lead to increased morbidity and mortality to the patients.

The main assumption of the so-called "preventive analgesia" is to try to prevent the influx of nociceptive stimuli (surgical trauma) to the spinal cord and thus reduce postoperative pain. For this purpose, various anesthesiologic regional techniques (epidural analgesia, transversus abdominis plane block) are used for trying to reduce the activation of postoperative pain. Timely application of "preventive analgesia" and its long enough and intense action are essential as they could be captured all afferent nociceptive impulses. In the choice of optimal analgesia, the type and location of the procedure, the duration of the analgesic therapy required, individual risk factors and contraindications are of great importance. Preventive analgesia may be initiated immediately before the onset of tissue injury (eg epidural or spinal analgesia), immediately after surgery using regional blocks or intravenous analgesia for a well-defined period of time (eg at intervals of 3 to 6 hours). The goal of quality treatment of acute pain is not only optimal analgesia, but also for reducing complications. One of the newer techniques for postoperative analgesia is a transversus abdominis plane block (TAP), which is part of regional anesthesia techniques. It is a peripheral nerve block that blocks nerves located in the fascia layer between the m. transversus abdominis and the m. obliqus internus, which innervate the anterolateral abdominal wall. These nerves include the intercostal (Th7-Th11), subcostal (Th12), iliohypogastric and ilioinguinal (L1) nerves. A local anesthetic administered in the layer between the m. transversus abdominis and the m. obliqus internus results in anesthesia of the anterolateral abdominal wall. This technique achieves analgesia of the skin, subcutaneous, muscle, and parietal peritoneum in a given region. The blockage of these nerves is useful primarily for postoperative analgesia after abdominal surgery, including gynecologal too.

In major surgical procedures such as uterine removal (hysterectomy), pain and stress caused by surgical tissue injury stimulate a strong pro-inflammatory response, so establishing effective postoperative analgesia which adequately relieved the pain is of great importance. In this study, investigators will evaluate the effect of a transversus abdominis plane block on the severity of postoperative pain as well as its effect on proinflammatory and pain factors in patients following gynecologic surgery performed with a laparotomy approach. The investigators will also compare the use of standard systemic multimodal analgesia and the TAP block (as well as their combination) in the control of postoperative pain. Studies have shown that both approaches are effective in controlling postoperative pain, but comparative studies are rare, and none has so far examined the concentration of proinflammatory and pain factors in operated patients.

Hypothesis

The basic hypothesis is that a transversus abdominis plane block reduces postoperative pain in patients after gynecologic surgery performed with a laparotomic approach. The expectation is that the concentration of proinflammatory and pain factors in patients treated with a TAP block will be lower and the quality of recovery will be better than that of patients receiving standard analgesic therapy (systemic multimodal analgesia).

Objectives of the research

1. Compare the three forms of postoperative analgesia dividing patients in the three groups (TAP block only, systemic multimodal analgesia only and combined TAP block with systemic multimodal analgesia) after gynecological surgeries to show which one has the highest value in controlling postoperative pain.
2. Analyze the impact of the TAP block on postoperative pain, using a visual analogue scale (VAS) in patients after gynecological surgery.
3. Analyze the impact of TAP block combined with systemic, multimodal analgesia on postoperative pain, using the VAS scale, in patients after gynecological surgery.
4. Analyze the concentration of proinflammatory cytokines and pain factors (IL-1ß, IL-6, cortisol, catecholamines) in the plasma of patients who will receive a TAP block after gynecological surgery.
5. Analyze the impact of the TAP block on the quality of recovery, measured with quality of recovery (QoR) questionnaire in patients after gynecological surgery.
6. Correlate values of subjective assessment of postoperative pain intensity using VAS scale with concentration of proinflammatory and biomarkers for pain (IL-1ß, IL-6, cortisol, catecholamines) in patients in whom postoperative pain after gynecological surgery will be treated with TAP block or systemic multimodal analgesia.

Construction of the study

The structure will be a prospective, randomized, single-blind study.

Subjects (Material)

The number of women enrolled in the study will be 75. Patients will be interviewed in detail prior to surgery to be informed of planned anesthesia, surgery and postoperative pain control, and will sign informed consent and consent to participate in the study.

From each patient by standard technique venous blood will be taken out from peripheral vein at certain intervals after surgery. The patients will be asked by the examiner to complete VAS scale or and the QoR questionnaire.

Methods

Hysterectomy and / or adnexectomy will be performed in patients included in the study due to benign gynecological pathology with a laparotomy approach. Baseline patient data will be determined based on a detailed medical history and medical records, clinical examination of each patient and imaging tests. A definitive diagnosis of benign gynecological pathology will be obtained after a histopathological analysis of the tissue. A detailed interview will be done with the patients before surgery, and patients will be informed about the planned anesthesia, surgery and postoperative pain control. After that patients will sign an informed consent and the consent for participating in the study. For the purpose of the study, patients will be randomized into three groups regarding to the treatment technique for postoperative pain. The doctor ( researcher) will, by the computer program Datlnf Ranolist do the randomization. So that way the researcher will determine the type of analgesia the patient will receive. In the first group, patients will receive intravenous, systemic, multimodal analgesia: paracetamol 1 gram and ketoprofen 100 mg every 8 hours for 24 hours. Analgesia will start immediately after surgery. If the pain persists, the patient will be given "rescue" analgesia: tramadol 50 mg intravenously up to a maximum dose of 400 mg / 24 h and other analgesics if needed. In the second group there will be patients in who will be given the TAP block. The TAP block will be given postoperatively before waking. It will be given bilaterally in the before mentioned anatomic region (the so-called lateral TAP block) of 0.25% levobupivacin in 40 ml bilaterally. If such analgesia is not satisfactory, tramadol 50 mg intravenously, up to a maximum dose of 400 mg / 24h, and other analgesics will be given at the request of the patient. In the third group there will be patients who will be treated with TAP block in addition to systemic, mutimodal analgesia. If such analgesia is not satisfactory, tramadol 50 mg intravenously, up to a maximum dose of 400 mg / 24h, and other analgesics will be given at the request of the patient. The standardized protocol will determine the general information of each patient to be included in the study: ID, age and gender. 25 patients will be included in each group. The research will be based on completing a questionnaire (VAS scale and QoR questionnaire) and taking peripheral blood out. Blood will be taken from the peripheral vein by standard technique in a volume of 10 ml before surgery and 6, 24 and 48 hours after surgery. VAS scale (at rest and in motion) will be determined before surgery and 3, 6, 12, 24 and 48 hours after surgery. The QoR questionnaire will be examined before surgery, 24 hours after surgery and 30 days after surgery. The concentrations of individual cytokines (IL-1ß, IL-6) and hormones (catecholamines, cortisol) related to inflammation and pain will be determined by standard laboratory methods from peripheral blood. Cytokine and hormone concentrations will be determined by enzyme immunofluorescence method according to the manufacturer's instructions. All results obtained through the questionnaire or blood test will only serve for the purpose of the study and will not have diagnostic, therapeutic or prognostic value for the patients included in the study.

Statistical methods

Statistical data processing will be performed in the Statistica 12.0 computer program (StatSoft, Inc., Tulsa, OK, USA). When calculating differences between experimental groups, investigators will use the Kruskal Walis ANOVA nonparametric test for small independent samples. Changes will be considered statistically significant with p \<0.05. We will use the Mann-Whitney U test subsequently to determine between which two of the more comparable groups there is statistical significance. Correlations will be examined by Pearson or Spearman correlation test, depending on the results of the data distribution analysis. Differences between variables expressed at nominal level will be examined using the chi-square test. Image and spreadsheet views of the results will be made in Microsoft Excel and Statistica 12.0.

Expected scientific contribution

It is hoped that the results of the proposed study will shed light on the impact of various anesthesiologic techniques (transversus abdominis plane block, intravenous systemic multimodal analgesia and their combination) on postoperative pain and the concentration of proinflammatory and pain factors after gynecologic surgery performed with a laparotomy approach. Investigators expect that the use of regional analgesia technique (TAP block) will lead to a reduction in postoperative pain and proinflammatory factors and pain factors examined, thereby contributing to a faster recovery and better outcome of their treatment.

The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures

The Influence of the Transversus Abdominis Plane Block on the Intensity of Postoperative Pain and the Concentration of Proinflammatory and Pain Factors After Laparotomy for Gynecological Procedures

Self-reported pain intensity using a standard visual analogue scale (VAS, from 0 to 10) in patients after gynecological surgery.

Change in concentrations of individual cytokines (IL-1ß, IL-6) and hormones (catecholamines, cortisol) related to inflammation and pain

The impact of three forms of postoperative analgesia (TAP block, systemic multimodal analgesia and combined TAP block and systemic multimodal analgesia) on the quality of recovery in patients after gynecological surgery, measured by using a widely accepted 40-item Quality of Recovery (QoR) questionnaire

Clinical Hospital Center Rijeka

General Hospital Pula

Principal Investigator

Pelvic Pain

Hyperplasia

Endometrial Hyperplasia

Adenomyosis

Neoplasms, Connective Tissue

Connective Tissue Diseases

Stuart Hart, MD

This is an observational, exploratory study designed to collect (record) and analyze normal and abnormal sound data from the human bladder during surgery using a novel sensor-based catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes of baseline bladder and ureteral function. The Electronic Catheter Stethoscope device will measure acoustic and pressure data within the bladder. The measurements will be used to detect any leakage from the bladder and/or changes in baseline ureteral flow by correlation of sound data with surgical data reported by the surgeon. These data will be used to develop algorithms to detect changes of baseline bladder and ureteral function. The algorithms will be tested in future clinical trials.

Electronic Catheter Stethoscope

Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery

University of South Florida

Prostatic Neoplasms

Urinary Retention

Cystitis

Cystitis, Interstitial

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Urinary Bladder Diseases

Urologic Diseases

Urination Disorders

Kenneth Peters, MD

The purpose of initiating the Urology Database is to evaluate the outcomes of urology procedures and medical management to enhance the care and treatment of urology patients.

The current study population will include all patients having had a radical prostatectomy for the treatment of prostate cancer, surgical prolapse repair as well as patients having had InterStim sacral nerve stimulator implantation. The database will house data extracted from the medical records. Patient demographics, and preoperative, intra-operative, postoperative, and follow-up clinical data will be collected.

Urology Database to Evaluate Clinical Information and Improve Patient Care.

Urology Database for Outcomes Research

William Beaumont Hospitals

Nutritional and Metabolic Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Obesity

Hernia

Obesity, Morbid

Mediastinal Neoplasms

Hernia, Inguinal

Hernia, Ventral

Thymoma

Thymus Neoplasms

Hernia, Abdominal

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Thoracic Neoplasms

Lymphatic Diseases

Mediastinal Diseases

Thoracic Diseases

Respiratory Tract Diseases

Subjects scheduled to undergo robotic-assisted surgery

Robotic-assisted Surgery

This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.

Clinical Investigation of the da Vinci Surgical System

A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System

Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.

Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.

Intuitive Surgical

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures	NCT04172272	Leiomyoma Pelvic Organ Pr... Abnormal Uterin... Chronic Pain Premalignant Le... Endometriosis	Systemic multim... Transversus abd... Combined transv...	18 Years -	General Hospital Pula
Electronic Catheter Stethoscope	NCT01463462	Pelvic Organ Pr... Gynecologic Can... Uterine Leiomyo... Adenomyosis Endometrial Hyp... Other Abnormal ... Pelvic Mass Pelvic Pain		18 Years -	University of South Florida
Urology Database to Evaluate Clinical Information and Improve Patient Care.	NCT00376298	Incontinence Prostate Cancer Interstitial Cy... Urinary Retenti... Pelvic Organ Pr...		18 Years -	William Beaumont Hospitals
Clinical Investigation of the da Vinci Surgical System	NCT05682742	Thymoma Mediastinal Tum... Gynecologic Dis... Gynecologic Can... Pelvic Organ Pr... Prostate Diseas... Prostate Cancer Inguinal Hernia Ventral Hernia Obesity, Morbid	Robotic-assiste...	21 Years -	Intuitive Surgical
Urology Database to Evaluate Clinical Information and Improve Patient Care.	NCT00376298	Incontinence Prostate Cancer Interstitial Cy... Urinary Retenti... Pelvic Organ Pr...		18 Years -	William Beaumont Hospitals
Electronic Catheter Stethoscope	NCT01463462	Pelvic Organ Pr... Gynecologic Can... Uterine Leiomyo... Adenomyosis Endometrial Hyp... Other Abnormal ... Pelvic Mass Pelvic Pain		18 Years -	University of South Florida

Spots Global Cancer Trial Database for pelvic organ prolapse