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临床试验/NCT03897764
NCT03897764已完成4 期

A Novel Analgesic Method for Postoperative Pain Relief After Cesarean Section: Intraoperative Superior Hypogastric Block

Maltepe University2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2019年1月2日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
154
试验地点
2
主要终点
Pain scores on rest and on movement at 24 th hour after surgery

研究概览

简要总结

Cesarean section is the most common inpatient surgical procedure in the United States with 1.3 million cesarean deliveries performed in 2015. Cesarean section frequency is increasing rapidly in worldwide, especially in middle and high income countries.

Postoperative pain is an expected outcome for patients following surgical procedures. Inadequate pain relief is still a common problem among hospitalized patients. Cesarean section ranked ninth for pain severity among 179 different surgical procedures.

Multimodal pain therapy has been suggested for postoperative pain management after cesarean delivery. The most commonly used modalities are systemic administration of opioids, either by intramuscular injection or IV by patient-controlled analgesia, and neuraxial injection of opioid as part of a regional anesthetic for cesarean delivery. These techniques have specific advantages and disadvantages.

Superior hypogastric plexus blockade (SHB) has been shown an effective method for pain relıef after gynecologic procedures, it has been shown that SHP can be easily performed intraoperatively during hysterectomy procedure In this study, we aimed to investigate the efficacy of SHB performed intraoperatively for postoperative pain relief after cesarean section. To our knowledge, this is the first study to use SHB intraoperatively for pain relief after cesarean section in the literature.

详细描述

Cesarean section is a life-saving surgical operation performed during pregnancy and labor. It is the most common inpatient surgical procedure in the United States with 1.3 million cesarean deliveries performed in 2015. Cesarean section frequency is increasing rapidly in worldwide, especially in middle and high income countries.

Postoperative pain is an expected outcome for patients following surgical procedures. Inadequate pain relief is still a common problem among hospitalized patients. A number of surveys report that 30%-70% of surgical patients experience moderate to severe pain (Breivik) At least 10.9% of women experience severe pain within 24 h after cesarean section. An analysis of 50523 patients from 105 hospitals questioning pain intensity on the first postoperative day revealed that cesarean section ranked ninth for pain severity among 179 different surgical procedures.

In this regard, multimodal pain therapy has been suggested for postoperative pain management after cesarean delivery. It requires the use of a combination of drugs with different mechanisms of action, and aims at achieving optimal analgesia through additive or synergistic drug action with small doses of opiates and decreased side effects. The most commonly used modalities are systemic administration of opioids, either by intramuscular injection or IV by patient-controlled analgesia, and neuraxial injection of opioid as part of a regional anesthetic for cesarean delivery. These techniques have specific advantages and disadvantages.

Recently, superior hypogastric plexus blockade (SHB) has been shown an effective method for pain relıef after gynecologic procedures, i.e. hysterectomy (kaynak). The superior hypogastric plexus (SHP) is a retroperitoneal structure located bilaterally at the level of the lower third of the fifth lumbar vertebral body and upper third of the first sacral vertebral body at the sacral promontory in which it is most accessible to block for pelvic pain relief. Besides it can be performed either by fluoroscopy-guided, ultrasound (US)-guided, or CT-guided techniques, it has been shown that SHP can be easily performed intraoperatively during hysterectomy procedure ().

In this study, we aimed to investigate the efficacy of SHB performed intraoperatively for postoperative pain relief after cesarean section. To our knowledge, this is the first study to use SHB intraoperatively for pain relief after cesarean section in the literature.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Patients were randomly allocated in two groups. The allocation sequence was generated by a random number table, and group allocation was concealed in sealed, opaque envelopes that were not opened until operation. During the operation the envelope was opened by a nurse outside the operating theatre. The nurse prepared a blind syringe with the study drug, which was then transferred to a sterile bowl in the operating room and injected. Both bupivacaine and saline are colourless and not possible to identify the solution by its visual appearance, or by smell. The envelope was then sealed again and not opened until the study was concluded. The patients, anesthesiologists, and nurses providing postoperative care were blinded to group assignment

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Term singleton pregnant women between ages 18 to 40 with no previous history of cesarean section or abdominal surgery were scheduled for elective cesarean operation under general anaesthesia. Only ASA 1-2 patients were included to the study.

排除标准

  • We excluded patients with suspected or manifest bleeding disturbances, chronic pelvic pain, allergy to NSAID's or opioids, atopia, bronchial asthma, diabetes mellitus, the presence of liver or kidney diseases, abuse of drugs or alcohol, and patients with pregnancy-induced hypertension or preeclampsia. The patients underwent emergency cesarean section were also excluded from the study.

研究组 & 干预措施

Superior Hypogastric Block group

Experimental

The group which superior hypogastric block performed intraoperatively

干预措施: Intraoperative superior hypogastric plexus block (Procedure)

placebo controlled group

Placebo Comparator

The group which placebo used

干预措施: Intraoperative superior hypogastric plexus block (Procedure)

结局指标

主要结局

Pain scores on rest and on movement at 24 th hour after surgery

时间窗: up to 24 hours

Postoperative pain assessed by the 10 cm visual analogue scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable

次要结局

  • length of surgery(Up to 1 hour)
  • Pain scores on rest and on movement at 2,6 and 48 th hour after surgery(Up to 48 hours)
  • Rate of nausea and vomiting(Up to 48 hours)
  • Opioid or NSAID requirement after surgery(Up to 48 hours)
  • Return of gastrointestinal function(Up to 48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berna Haliloglu Peker

Prof. Dr. Berna Haliloglu Peker

Maltepe University

研究点 (2)

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