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Pain, Postoperative clinical trials

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NCT ID: NCT05187520 Not yet recruiting - Cesarean Section Clinical Trials

Naldebain for Control of Post-Cesarean Section Pain

Start date: September 1, 2022
Phase: Phase 2
Study type: Interventional

Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Patient-controlled epidural analgesia (PCEA) is considered as the standard pain management strategy for post-cesarean pain. However, correct placement of epidural catheter for effective postoperative pain management is more technical demanding, and accidental dural puncture is associated with increased risk of postdural puncture headache. It also increases risk of other complications, including urinary retention, systemic toxicity of local anesthetics and formation of epidural hematoma. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard PCEA and prevent the development of CPSP.

NCT ID: NCT05187390 Recruiting - Postoperative Pain Clinical Trials

Incidence of Chronic Pain After Video-Assisted Thoracic Surgery

Start date: December 14, 2021
Phase:
Study type: Observational

Video-assisted thoracic surgery (VATS) is frequently performed in thoracic surgery. It is widely accepted that VATS causes acute pain. Many factors such as postoperative analgesia treatment plan, operation time, number of chest tubes, and duration of chest tube stay can affect acute pain. This acute pain prolongs the discharge time of the patients and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Postoperative acute pain may cause chronic pain in the later period, and may adversely affect the quality of life of the patients. This study, it was aimed to analyze the symptoms of chronic pain in the 1st and 3rd months postoperatively in patients who had undergone VATS.

NCT ID: NCT05186532 Completed - Pain, Postoperative Clinical Trials

Dry Heat Versus Sitz Bath On Episiotomy Wound Heating And Pelvic Pain

Dry_Heat
Start date: January 5, 2021
Phase: N/A
Study type: Interventional

Objective: To compare the effect of dry heat versus moist heat application on episiotomy wound healing and pain among postnatal mothers. Research hypothesis H0: Postnatal mothers who apply dry heat on their episiotomy wound experience the same wound healing and pain as those who apply moist heat. H1: Postnatal mothers who apply dry heat on their episiotomy wound experience faster wound healing and less pain than those who apply moist heat. H2: Postnatal mothers who apply moist heat on their episiotomy wound experience faster wound healing and less pain than those who apply dry heat.

NCT ID: NCT05186467 Recruiting - Clinical trials for Post Operative Pain, Acute

Pain After Laparoscopy Results From the Incision, Manipulation of the Abdominal Organs, and Retained CO2(Back Pain)

Start date: September 2, 2021
Phase: Phase 2
Study type: Interventional

Postoperative pain after laparoscopy may be localized pain resulting from incision due to many (two or three) punctures (somatic pain) or due to manipulation of the intra-abdominal organs as ovaries, uterus, omentum, and intestine (visceral pain) or shoulder and back pain caused by retained CO2 in the peritoneal cavity with its irritation effect on the diaphragm.Patients will be divided into two groups: Intraperitoneal (IP) group (20 patients):They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy. Intravenous (IV) group (20 patients):They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy

NCT ID: NCT05186454 Recruiting - Post Operative Pain Clinical Trials

Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally

Start date: May 23, 2021
Phase: Phase 2
Study type: Interventional

Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam. Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine

NCT ID: NCT05185752 Completed - Postoperative Pain Clinical Trials

Comparative Analysis of Three Locoregional Anesthesia Methods in Breast Tumour Pathology Surgery

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The present study compares the Erector Spinae Plane (ESP) block, Pectoral (PECS II) block, and Serratus-Intercostal Fascial Plane (SIFP) block. This is the first article to compare these three locoregional nerve block techniques in acute and chronic postoperative pain in breast tumour surgery. From June 1, 2018, to June 30, 2019, 103 patients undergoing breast cancer surgery were randomised to undergo one of three locoregional techniques (35 for ESP block, 34 for PECS II block, 34 for SIFP block). Locoregional techniques were performed under light sedation and then, general anaesthesia was used for the breast cancer surgery. Outcomes measured included pain (visual analog scale [VAS] in immediate postoperatory and at 24 hours. It also was collected opioid use at 24 hours, adverse events, and length of stay (for acute postoperatory). Moreover, at 3 months, a telephone interview was conducted with the patient and VAS was questioned. A year later, the patient was questioned again and asked for VAS, location of her pain, and pharmacological treatment. It was collected if patients were assisted or not by a Pain Unit.

NCT ID: NCT05179928 Recruiting - Post Operative Pain Clinical Trials

Erector Spinae Plane Block Versus Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes. Background: Supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. Because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. Previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses. ESPB provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. RSB provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. The dermatomal distribution of ESPB and RSB makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them. Patients and Methods: This was a prospective, randomized (1:1), double-blind clinical trial; carried out on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group E; general anesthesia with postoperative bilateral ultrasound-guided ESPB, whereas in group R; general anesthesia with postoperative bilateral ultrasound-guided RSB.

NCT ID: NCT05178680 Recruiting - Anxiety Clinical Trials

Combination of Music and Relaxing Light on the Patient's Anxiety After Cardiac Surgery in the Intensive Care Unit

RéaRelax
Start date: May 13, 2022
Phase: N/A
Study type: Interventional

Cardiac surgery is not trivial. It requires opening the thorax in certain indications: coronary artery bypass grafting, valve replacements or plasties, aortic dissection, etc. These different procedures, both pre- and post-op, generate anxiety in the patient, the effects of which can be harmful to the recovery process and general well-being. It can be increased by the resuscitation environment during the immediate postoperative management. This environment also favors the development of delirium. It is possible to improve this environment by using non-drug and inexpensive techniques. Indeed, making the stay in the ICU better while respecting the safety of the patient and the efficiency of the care, could reduce anxiety as well as the appearance of delirium. Studies have been carried out on the effectiveness of music in health care with a positive impact on anxiety and pain. The proposed study aims to evaluate the implementation of relaxation moments adapted to the resuscitation sector from the day after surgery. They target the senses available and accessible at that moment, such as hearing (relaxing music chosen by the patient will be played) and sight (a multi-effect light projector and a bubble column will be deployed). Environmental stressors will be minimized, while maintaining an optimal level of safety. The primary objective is to compare anxiety before and after the first session in cardiac surgery patients in the cardiothoracic and vascular surgery (CCTV) resuscitation unit between the group with the usual rest session and the group with the rest session combining soft music and light. The secondary objectives are based on an evaluation of anxiety over different time periods, patient comfort, occurrence of postoperative delirium, patient pain, average length of stay (LOS). This is a pilot, comparative, monocentric, randomized, interventional research with minimal risks and constraints in 2 parallel groups. 110 patients will be included over a period of 12 months In the experimental group, once a day, a relaxation session with the association of soft music and light will be proposed by adapting the environment of the patient's resuscitation room. The control group will have the usual rest session.

NCT ID: NCT05178615 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Investigation of the Effect of Preoperative Education on Postoperative Outcomes in Total Knee Arthroplasty Patients

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Total knee arthroplasty surgery is a common surgical procedure used in the treatment of patients in the end stages of osteoarthritis. Arthroplasty surgery is a process that creates physical and psychological stress on the patient. Preoperative education can reduce anxiety and improve postoperative outcomes. In the studies on education in the literature, it is seen that there are trainings in the form of seminars, trainings made with video recordings, trainings in the form of brochures. Studies in the literature have shown that training given synchronously (live) by a healthcare professional is more effective in reducing anxiety in one-on-one or small-person groups. Less anxiety does not significantly reduce pain levels, but improves patients' ability to cope with pain and increases their perception of preparedness. Together, these two factors can improve patients' overall experience by increasing their sense of control and comfort.

NCT ID: NCT05177991 Recruiting - Inguinal Hernia Clinical Trials

Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs

Start date: March 1, 2022
Phase: Early Phase 1
Study type: Interventional

While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine (Exparel) to bupivacaine alone in formulation of the TAP block is particularly scarce. Therefore, we designed a prospective, randomized trial comparing the postoperative pain control in minimally invasive ventral and inguinal hernia repair patients who receive an Exaparel-based TAP block compared to the traditional bupivacaine (Marcaine) TAP block.