Analgesia Effects of Nalbuphine vs Sulfentanil

Analgesia Effects of Nalbuphine vs Sulfentanil in Patient-controlled Intravenous Analgesia After Cesarean Section

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.

Study Overview

• Status: Unknown
• Conditions: C.Delivery; Surgery (Previous), Gynecological
• Intervention / Treatment: Drug: Nalbuphine; Drug: flurbiprofen axetil; Drug: ramosetron; Drug: Sufentanil

Detailed Description

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
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Nalbuphine; patient-controlled intravenous analgesia; Other Names: nalbuphine 100 mg; Drug: flurbiprofen axetil; patient-controlled intravenous analgesia; Other Names: flurbiprofen axetil 50mg; Drug: ramosetron; patient-controlled intravenous analgesia; Other Names: ramosetron 0.3mg
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.	Drug: flurbiprofen axetil; patient-controlled intravenous analgesia; Other Names: flurbiprofen axetil 50mg; Drug: ramosetron; patient-controlled intravenous analgesia; Other Names: ramosetron 0.3mg; Drug: Sufentanil; patient-controlled intravenous analgesia; Other Names: sufentanil 100ug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain scores of nalbuphine group	up to 24 months
Pain scores of sufentanil group	up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Usage of nalbuphine of nalbuphine group	up to 24 months
Usage of sufentanil of sufentanil group	up to 24 months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Estimate): November 13, 2015
• Last Update Submitted That Met QC Criteria: November 11, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Serotonin Agents; Serotonin Antagonists; Adjuvants, Anesthesia; Nalbuphine; Sufentanil; Dsuvia; Flurbiprofen; Flurbiprofen axetil; Ramosetron
• Other Study ID Numbers: SShen