Comparison of Pudendal Nerve Block With Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The incidence of postoperative CRBD
研究概览
简要总结
Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this study, the investigators will enroll male patients undergoing elective prostate surgery with urinary catheterization after anesthetic induction, and compare the efficacy of pudendal nerve block (PNB) and intravenous tramadol in prevention of CRBD.
详细描述
The PNB trial is an investigator-initiated, prospective, randomized controlled trial that will test the superiority of pudendal nerve block with 0.33% ropivacaine to intravenous tramadol 1.5mg/kg for CRBD prevention. A total of 94 patients undergoing elective prostate surgery at lithotomy position with urinary catheterization (16 G Fr Foley catheter) after anesthetic induction under general anesthesia will be enrolled at West China Hospital of Sichuan University. Patients will be divided randomly into two groups:
The PNB group: patients will be given bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) after the completion of surgery before extubation.
The TRAM group: patients will be given tramadol of 1.5mg/kg after the completion of surgery before extubation.
All patients will be evaluated by a research nurse who were blinded to the group assignments for outcomes at 0, 1, 2, 4, and 6h after patients' arrival in PACU, and after extraction of urinary catheter.
The primary outcome is the incidence of postoperative CRBD. The secondary outcomes include the severity of postoperative CRBD, postoperative tramadol requirement and number of patients with requiring postoperative tramadol, numeric rating scale (NRS) for postoperative pain, postoperative sufentanil requirement and number of patients with requiring postoperative sufentanil, postoperative side effects, and acceptance of indwelling urinary catheter after extraction of the catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18years to 75years.
- •American Society of Anesthesiologists (ASA) physical status I, II, or Ⅲ.
- •Undergoing elective prostate surgery at lithotomy position with urinary catheterization after anesthetic induction under general anesthesia.
- •Glasgow Coma Scale (GCS) score of
- •Ability to communicate.
排除标准
- •History of bladder dysfunction, such as over active bladder (OAB, urinary frequency: more than three times in the night or more than eight times in 24 h).
- •History of bladder outflow obstruction.
- •Neurogenic bladder.
- •Impaired renal function.
- •Coagulopathy.
- •Known allergies to any anesthetic agent.
- •Family history of malignant hyperthermia.
- •Impairment of communication or cognition.
- •Psychopathy.
- •Active participation in another trial where the primary endpoint follow-up is ongoing.
- •Unwillingness or inability to comply with protocol procedures.
研究组 & 干预措施
The PNB group
Bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) will be performed after the completion of surgery before extubation.
干预措施: Bilateral pudendal nerve block (Procedure)
The TRAM group
Intravenous tramadol of 1.5mg/kg will be administrated after the completion of surgery before extubation.
干预措施: Intravenous tramadol (Drug)
结局指标
主要结局
The incidence of postoperative CRBD
时间窗: 1 day
Patients complained about postoperative CRBD
次要结局
- Incidences of postoperative side effects(1 day)
- The severity of postoperative CRBD(1 day)
- Postoperative tramadol requirement(1 day)
- Numeric rating scale (NRS) for postoperative pain.(1 day)
- Postoperative sufentanil requirement(1 day)
- Acceptance of indwelling urinary catheter after extraction of the catheter(1 week)
研究者
Ren Liao
Associate Professor
West China Hospital