Analgesia Effects of Nalbuphine vs Sulfentanil
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| ClinicalTrials.gov Identifier: NCT02604797 |
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Recruitment Status : Unknown
Verified October 2015 by Sun Shen, Fudan University.
Recruitment status was: Not yet recruiting
First Posted : November 13, 2015
Last Update Posted : November 13, 2015
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Cesarean section may result in great trauma and postoperative pain. Besides incision pain, uterine contraction pain is another source of postoperative pain after cesarean section. In clinical practice, a large amount of uterine contraction agent is routinely applied after cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage, which also causes great uterine contraction pain. Acute pain is the risk factor of chronic pain, and may postpone the recovery from labour and influence the quality of life of parturient. Though various analgesia modules have been attempted, more than 20% parturients still experience severe postoperative pain, and pain management after cesarean section remains a challenge to anesthesiologists.
This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on patient-controlled intravenous analgesia after cesarean section.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| C.Delivery; Surgery (Previous), Gynecological | Drug: Nalbuphine Drug: Sufentanil Drug: flurbiprofen axetil Drug: ramosetron | Not Applicable |
Cesarean section may result in great trauma and postoperative pain. Besides incision pain, uterine contraction pain is another source of postoperative pain after cesarean section. In clinical practice, a large amount of uterine contraction agent is routinely applied after cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage, which also causes great uterine contraction pain. Acute pain is the risk factor of chronic pain, and may postpone the recovery from labour and influence the quality of life of parturient. Though various analgesia modules have been attempted, more than 20% parturients still experience severe postoperative pain, and pain management after cesarean section remains a challenge to anesthesiologists.
Opiate drugs constitute the baseline medication for postoperative analgesia. However, pure μ opioid receptor agonist like morphine and fentanyl may induce adverse effects such as nausea, vomiting, dizziness, drowsiness and respiratory depression. Nalbuphine hydrochloride is an opiate-like substance structure-related oxymorphone, which is a κ receptor agonist/μ receptor partial antagonistic type analgesia drug. Specific κ receptor agonist and gene knockout experiment reveals that κ receptor agonist depresses the visceral pain induced by chemical stimulation, the effect of which outperforms pure μ opioid receptor agonist. Studies have discovered that some κ receptor agonists can reduce or inhibit the side effects of μ receptor agonist such as tolerance or dependence. The adverse effects of μ receptor agonist such as pruritus, nausea, vomiting, delayed gastric emptying are caused by the drug on peripheral opioid receptor, and can be relieved by opioid receptor agonist. The structure of nalbuphine hydrochloride is related to naloxone, an opioid receptor antagonist, therefore, the incidence of adverse effects of nalbuphine hydrochloride is lower than that of μ receptor agonist. In recent years, nalbuphine hydrochloride has become more and more popular in postoperative analgesia. There has been reports on intrathecal administration of nalbuphine hydrochloride for analgesia after cesarean section, while the effect of intravenous administration of nalbuphine hydrochloride on analgesia after cesarean section remains undetermined. This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on patient-controlled intravenous analgesia after cesarean section.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Analgesia Effects of Nalbuphine vs Sulfentanil in Patient-controlled Intravenous Analgesia After Cesarean Section |
| Study Start Date : | January 2016 |
| Estimated Primary Completion Date : | January 2017 |
| Estimated Study Completion Date : | January 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Nalbuphine
Nalbuphine group: nalbuphine 100 mg, ramosetron 0.3mg, background dose 1ml/h,patient-controlled analgesia(PCA) 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation.
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Drug: Nalbuphine
patient-controlled intravenous analgesia
Other Name: nalbuphine 100 mg Drug: flurbiprofen axetil patient-controlled intravenous analgesia
Other Name: flurbiprofen axetil 50mg Drug: ramosetron patient-controlled intravenous analgesia
Other Name: ramosetron 0.3mg |
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Experimental: Sufentanil
Sufentanil group: sufentanil 100ug, ramosetron 0.3mg, background dose 1ml/h, PCA 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation.
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Drug: Sufentanil
patient-controlled intravenous analgesia
Other Name: sufentanil 100ug Drug: flurbiprofen axetil patient-controlled intravenous analgesia
Other Name: flurbiprofen axetil 50mg Drug: ramosetron patient-controlled intravenous analgesia
Other Name: ramosetron 0.3mg |
- Pain scores of nalbuphine group [ Time Frame: up to 24 months ]
- Pain scores of sufentanil group [ Time Frame: up to 24 months ]
- Usage of nalbuphine of nalbuphine group [ Time Frame: up to 24 months ]
- Usage of sufentanil of sufentanil group [ Time Frame: up to 24 months ]
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- For primipara with selective cesarean section
Exclusion Criteria:
- Severe preeclampsia,
- pregnancy complicated with diabetes mellitus
- pregnancy complicated with cardiac disease,
- gestation age<37W
- recently use of opiate drugs or nonsteroidal antiinflammatory drugs within 48 h before operation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604797
| Contact: Shen Sun | sunshen1980@126.com |
| Study Director: | Shaoqiang Huang | Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China |
| Responsible Party: | Sun Shen, Principal Investigator, Fudan University |
| ClinicalTrials.gov Identifier: | NCT02604797 |
| Other Study ID Numbers: |
SShen |
| First Posted: | November 13, 2015 Key Record Dates |
| Last Update Posted: | November 13, 2015 |
| Last Verified: | October 2015 |
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Flurbiprofen Flurbiprofen axetil Sufentanil Dsuvia Nalbuphine Ramosetron Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous |
Anesthetics, General Anesthetics Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiemetics Autonomic Agents Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |