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Showing 1-20 of 110 trials
NCT07454629
This prospective observational study aims to examine the relationship between fluctuations in anesthesia depth, measured by bispectral index (BIS) monitoring during surgery, and changes in patients' postoperative recovery quality. BIS monitoring is routinely used during general anesthesia to assess the depth of anesthesia, but BIS values often fluctuate over time rather than remaining stable. The clinical significance of this variability is not well understood. In this study, BIS variability during anesthesia induction and maintenance will be evaluated and compared with changes in postoperative recovery quality. Recovery quality will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which will be administered before surgery and again on the first postoperative day. The primary outcome of the study will be the change in QoR-15 score from the preoperative baseline to postoperative day one (ΔQoR-15). Delirium screening and routine perioperative clinical data will also be collected. No additional interventions beyond standard anesthesia care will be performed. The results of this study may help improve understanding of how intraoperative anesthesia stability relates to patient recovery after surgery.
NCT06743919
Laparoscopic cholecystectomy (LC) is one of the commonly performed surgical procedures associated with a moderate degree of postoperative pain especially on the 1st postoperative day. Adequate postoperative analgesia allows early patient ambulation, decreases analgesic requirements, and hospital stay. Moreover, it has been hypothesized that intense acute pain after LC may predict development of chronic pain (e.g., post laparoscopic cholecystectomy syndrome). So, aggressive perioperative analgesia is needed. the aim of the study is To compare the analgesic effect of magnesium sulfate combined with bupivacaine versus bupivacaine combined dexmedetomidine via OSCTAB block on postoperative pain control for 24 hours in patients scheduled for LC.
NCT06885086
This clinical study aims to evaluate the effects of multimodal analgesia management administered within an ERAS (Enhanced Recovery After Surgery) protocol on postoperative pain, length of hospital stay, early complications, and additional opioid requirements in patients undergoing laparoscopic cholecystectomy. The key questions addressed are: * Does ERAS-based multimodal analgesia reduce postoperative pain? * Does it shorten the hospital stay and lower early complication rates? * What is its potential to reduce the need for additional opioids? Participants: * Prospective Group: Patients managed with an ERAS multimodal analgesia protocol (including paracetamol, NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), and local wound infiltration analgesics) between April and July 2025. * Retrospective Group: Patient records from 2024 who were treated with a routine analgesia protocol. Based on a power analysis, a minimum of 60 patients per group (total of 120 patients) will be included in the study (If the required sample size determined by the power analysis cannot be reached, the number of patients within the predefined time frame will be accepted as the sample).
NCT07450781
Laparoscopic cholecystectomy has become the gold standard for the operative treatment of gallbladder disease due to its minimally invasive nature and improved patient outcomes. However, postoperative pain remains a significant concern following this procedure, affecting patient comfort, recovery, potential for same day discharge and overall satisfaction. However, visceral pain, port-site pain, and referred shoulder pain are occasionally reported in laparoscopic cholecystectomy patients . Postoperative shoulder pain is a common complication following laparoscopic cholecystectomy, often attributed to diaphragmatic irritation.
NCT07473388
This randomized controlled trial compares the operative outcomes of clipless laparoscopic cholecystectomy using a harmonic scalpel (HS) versus conventional clip-based laparoscopic cholecystectomy (CLC) in patients with gallstone disease. The primary goals are to determine if the clipless HS technique reduces operative time and intraoperative blood loss. Secondary outcomes include the length of postoperative hospital stay and the rate of port-site infections.
NCT06651450
Laparoscopic (closed) surgery provides several advantages over open surgery, such as smaller surgical incisions, postoperative recovery, and shorter hospital stay. However, increased intra-abdominal pressure (IAP) during surgery may have adverse effects on some systems such as circulation and respiration. Increased IAP may reduce blood return to the heart. Some studies have shown that some values calculated from surface electrocardiography are associated with changes in heart rhythm. Changes in blood pressure, nervous, and hormonal systems that may be seen due to increased IAP in laparoscopic surgery may cause arrhythmias in patients.Therefore, researchers aimed to investigate the effects of increased IAP on electrocardiography in patients undergoing laparoscopic cholecystectomy.
NCT07457905
This descriptive observational study aims to examine the relationship between preoperative fear of postoperative pain and postoperative pain intensity in patients undergoing cholecystectomy. Postoperative pain is one of the most common and significant clinical problems following surgical procedures. Psychological factors such as anxiety and fear of pain are known to influence pain perception and recovery outcomes. Preoperative fear related to postoperative pain may increase perceived pain intensity and negatively affect the postoperative recovery process. The study will be conducted in the general surgery clinics of a tertiary care hospital. A total of 106 adult patients scheduled for cholecystectomy will be included. Preoperative fear of postoperative pain will be assessed one day before surgery using the Postoperative Pain Fear Scale. Postoperative pain intensity will be evaluated using the Numeric Rating Scale at the 4th, 12th, and 24th hours after surgery. The findings of this study are expected to contribute to a better understanding of the relationship between preoperative pain-related fear and postoperative pain severity, and to provide evidence to improve perioperative nursing care and pain management strategies.
NCT07195331
Introduction: This protocol outlines a randomized phase IV clinical trial designed to compare the efficacy of two different doses of indocyanine green (ICG) used in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy (LC)-the current gold standard treatment for symptomatic cholelithiasis. Despite its effectiveness, LC is still associated with significant risks, particularly bile duct injury (BDI), a severe complication that this study aims to mitigate. Phase: Phase IV Study design: Multicenter, randomized, open-label, parallel-group clinical trial (modified intention-to-treat). Objectives: Primary objective: * To analyze differences between treatment groups (standard dose 2.5 mg \>3h preoperative vs reduced dose 0.25 mg immediate preoperative 15-30 min) during laparoscopic cholecystectomy in: * Visualization of extrahepatic biliary structures * Degree of visualization * Degree of background liver fluorescence interference * Perceived utility of the technique Secondary objectives: * Influence of BMI, biliary pathology type, surgery type, prior inflammation, surgical difficulty, previous instrumentation, and laparoscopic imaging system on results * Intraoperative and postoperative complication rates * 30-day mortality * Impact on operative time and hospital stay * Correlation between subjective and objective fluorescence assessment (ducts-to-liver fluorescence ratio) Population: Patients ≥18 years indicated for laparoscopic cholecystectomy (elective, early or urgent deferred). Main inclusion criteria: * Age ≥18 years * Signed informed consent * Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis, gallbladder polyps with surgical indication) Main exclusion criteria: * Age \<18 years * Pregnancy or lactation * Chronic kidney disease (stage \>IIIb) * ICG or iodinated contrast allergy * Functional thyroid disease * Emergency non-deferrable surgery * Open approach * Suspicion of gallbladder carcinoma * Inability to understand the study Investigational product: Indocyanine green (ICG), intravenous administration This multicenter study involves two hospitals in Castilla y León, Spain, and plans to enroll 122 adult patients meeting specific clinical criteria for LC. Participants will be randomized into two treatment arms and will receive ICG accordingly: * Group 1: 2.5 mg \>3h before surgery * Group 2: 0.25 mg 15-30 min before surgery Fluorescence will be assessed both subjectively by the surgical team and objectively through digital image analysis using specialized software to calculate the bile duct-to-liver fluorescence ratio (RFBH). Endpoints: * Rates and degree of biliary structure identification pre- and post-dissection * Perceived utility of cholangiography * Liver background fluorescence interference * Ducts-to-liver fluorescence ratio Duration: 12 months recruitment + 1 month follow-up = total 13 months Countries: Spain Ethics: The study will be conducted in accordance with ICH-GCP, EU Clinical Trials Regulation No 536/2014, and applicable national regulations. Beyond comparing the diagnostic performance of two dosing strategies, this study seeks to provide evidence supporting a more practical and logistically feasible approach for implementing ICG fluorescence cholangiography in routine surgical practice, without compromising diagnostic accuracy or patient safety.
NCT07437599
This research was designed as a randomized controlled trial to determine the effects of coffee sniffing on pain and physiological parameters in patients undergoing cholecystectomy surgery.
NCT07018258
This randomized clinical study aims to compare the postoperative analgesic efficacy, analgesic consumption, and patient satisfaction of erector spinae plane (ESP) block administered in three different patient positions-lateral, prone, and sitting-in individuals undergoing elective laparoscopic cholecystectomy. The study also evaluates the variation in skin-to-block site distance depending on patient positioning.
NCT07440940
This prospective randomized controlled trial aims to evaluate whether the timing of ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) affects postoperative pain in patients undergoing laparoscopic cholecystectomy. Participants will be randomly assigned to receive the combined regional blocks either before surgical incision or after completion of surgery. The primary outcome is postoperative pain intensity measured using a numerical rating scale. Secondary outcomes include opioid consumption, incidence of postoperative nausea and vomiting, and other recovery parameters. The results of this study may help optimize the timing of abdominal wall blocks to improve postoperative analgesia and recovery following laparoscopic cholecystectomy.
NCT07400237
This is a multicenter, prospective, interventional clinical trial designed to evaluate and compare two intraoperative imaging modalities: laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), for the identification of biliary anatomy in technically challenging laparoscopic cholecystectomy. All enrolled subjects will undergo both LUS and ICG during the index procedure, following a standardized sequence, in order to allow intra-subject comparison. LUS will be performed first, followed by fluorescence cholangiography prior to Calot's triangle dissection. The primary endpoint is the successful identification of the critical junction. Secondary endpoints include visualization of individual biliary structures, time to visualization, total operative time, intraoperative and postoperative complications.
NCT07321639
Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described abdominal wall block performed by injecting local anesthetic between the rectus abdominis muscle and the costal cartilage of the 7th rib. Due to the cranial attachment of the rectus muscle, this technique provides effective analgesia to the sternal, epigastric, and upper-mid abdominal regions, corresponding to the T6-T10/11 dermatomal levels. RIFPB may be used as an adjunct technique for thoracic procedures or as a standalone block for abdominal surgery. Ultrasound-guided transversus abdominis plane block (TAPB) is performed by injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles. TAPB provides sensory blockade of the anterolateral abdominal wall at the T6-L1 dermatomal levels and is widely used for postoperative analgesia following abdominal surgeries, including laparoscopic cholecystectomy. This study aims to compare the effectiveness of US-guided RIFPB and TAPB on postoperative pain control after laparoscopic cholecystectomy.
NCT07332546
This prospective, randomized, controlled, assessor-blinded trial will evaluate whether bilateral ultrasound-guided external oblique intercostal block (EOIB) reduces postoperative opioid consumption and improves pain control after laparoscopic cholecystectomy, compared with no block.
NCT06869837
The aim of the study was to evaluate the response of regional anesthesia to remifentanyl consumption in patients undergoing laparoscopic cholecystectomy surgery.
NCT07119203
This is a single-center, randomized controlled, parallel, non-inferiority trial. All adult patients with benign gallbladder disease with an indication for cholecystectomy will be assessed for eligibility and included after obtaining informed consent. A total of 276 patients will be randomized to undergo either robotic cholecystectomy (RC) or laparoscopic cholecystectomy (LC). The primary endpoint will be the incidence and severity of postoperative complications within 30 days after surgery. Secondary endpoints include perioperative outcomes, total health care utilization, health-related quality of life (HR-QoL) as assessed by patient-reported outcome measures, and cost-effectiveness. Follow-up assessments will be conducted at 7 and 30 days postoperatively. This is the first randomized controlled trial designed to compare RC with LC in the treatment of benign gallbladder disease. The trial aims to evaluate the safety and non-inferiority of RC relative to LC, providing important evidence to guide the progress and adoption of robotic surgery in clinical practice.
NCT06632184
Brief Summary Background: Laparoscopic cholecystectomy is a common procedure where postoperative pain and nausea/vomiting (PONV) remain significant issues, impairing recovery. Standardized multimodal analgesia (e.g., PROSPECT guidelines) is effective for pain, but PONV incidence stays high. Preliminary evidence suggests that adding ondansetron to the standard intraperitoneal saline lavage could provide additional analgesic and antiemetic benefits by blocking peripheral 5-HT3 receptors at the trauma site. Objective: This pilot study aims to evaluate if intraperitoneal lavage with saline + 8mg ondansetron reduces the total burden of postoperative pain over the first 24 hours (Area Under the Curve of the Visual Analog Scale, AUC-VAS/24h) compared to saline lavage alone, within a standardized multimodal protocol. Methods: This is a phase IV, pilot, randomized, controlled, triple-blind clinical trial. 40 adult patients (ASA I-II) undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis (Nassar Grade I-II difficulty) will be randomly assigned (1:1) to: Control Group: 500 ml of 0.9% saline intraperitoneal lavage. Intervention Group: 500 ml of 0.9% saline + 8 mg ondansetron intraperitoneal lavage. The lavage is performed for 5 minutes at the end of surgery, followed by complete aspiration. All patients receive a strict multimodal perioperative protocol, including pre-incisional port site infiltration with bupivacaine 0.75%, standardized anesthesia, and postoperative analgesics. The use of intravenous ondansetron is prohibited to avoid confounding. Primary Outcome: Total postoperative pain burden (AUC-VAS/24h). Secondary Outcomes (Exploratory): PONV incidence; time to first rescue analgesia; rescue analgesic consumption (buprenorphine); postoperative sleep quality (Richards-Campbell Sleep Questionnaire); safety and adverse events.
NCT06712498
Objective: Regional anesthesia techniques, such as peripheral nerve blocks, have a lower side effect profile and higher patient satisfaction compared to central blocks. With the introduction of Ultrasonography (USG), these techniques have become more commonly and reliably performed. The purpose of our study is to compare parameters such as intraoperative hemodynamics, postoperative analgesic requirement, and patient satisfaction between patients undergoing External Oblique Intercostal Plane Block (EOIB) with those who did not receive EOIB, which has few studies conducted on it.
NCT02085902
Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy can be performed as outpatient surgery. This approach is difficult in many centers because of post operative pain and nausea/vomiting. The use of postoperative morphine may be responsible for the state of nausea. The use of ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to have their surgery as an outpatient. Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was used for the infiltration holes trocar. In recent years, ropivacaine is used for the reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the many publications made on this subject. Its use in the investigators daily surgery, however, has not been evaluated in ambulatory surgery.
NCT07193836
This study aims to evaluate the effect of intravenous lidocaine on consciousness changes during anesthesia in patients undergoing laparoscopic cholecystectomy or gynecologic surgery. A total of 150 patients will be randomly assigned to one of three groups: a single-dose lidocaine group, a continuous-infusion group, or a placebo group. All patients will receive standard anesthesia care, and the study will monitor brain activity using EEG-based PSi values to measure anesthesia induction time, recovery time, and changes in consciousness. The goal is to determine whether lidocaine can reduce the amount of anesthetic used, shorten the time to fall asleep, and promote faster awakening after surgery. The results may help improve anesthesia safety and enhance recovery in surgical patients.