Systemic Lidocaine Infusion or Quadratus Lumborum Block (in Addition to Intrathecal Morphine) Versus Intrathecal Morphine Alone as Part of a Gynecology-Oncology Surgery Early Recovery Protocol
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- PACU Post-operative opioid consumption
研究概览
简要总结
This study may provide evidence for whether or not systemic lidocaine infusion offers significant advantage over truncal regional blocks in gynecology oncology surgery patients in terms of post-operative analgesia, recovery, and safety profile. Further, it may show whether there is any increased efficacy of adding truncal regional block or systemic lidocaine versus intrathecal opioid administration alone.
详细描述
Systemic administration of intravenous lidocaine has a number of observed and theoretical advantages in the perioperative period. Systematic review of perioperative lidocaine infusions has shown a reduction in early post-operative pain scores in patients undergoing abdominal surgery, positive effects for GI recovery, reduction in post-operative opioid requirements, reduction in the incidence of post-operative nausea and vomiting, and decreased length of hospital stay. They have been shown to modulate the surgery-induced stress response in colorectal surgery and abdominal hysterectomy. Thoracic epidural analgesia was better as compared to intravenous lidocaine in a RCT of patients undergoing laparoscopic colorectal surgery as part of an enhanced recovery program, though there was similar impact on recovery of bowel function.
Truncal regional anesthesia has been utilized in open and closed abdominal operations with various levels of efficacy. A statistically significant, though marginal clinical analgesic benefit, by recorded opioid consumption, has been concluded by meta-analysis in patients undergoing abdominal laparotomy, laparoscopy, or cesarean delivery after US-guided TAP block. There was not found to be any additional benefit of TAP block in patients who received a spinal anesthetic that included a long-acting opioid. The interpretation of results was noted to be limited by the heterogeneity of the included studies and analysis, though. The conclusions of one study of open prostatectomy, as part of an ERP, was that neither systemic lidocaine nor TAP block improved post-operative analgesia. Both IV lidocaine and TAP block groups showed a reduction in post-operative opioid consumption, though to an insignificant degree. It was noted as a possibility that the other interventions as part of the ERP, such as scheduled administration of IV acetaminophen, could have resulted in the non-significant decrease in post-operative opioid requirement. A recent review of the use of TAP blocks in major gynecological, non-obstetric, surgery, including total abdominal hysterectomy, concluded that TAP blocks may contribute to early post-operative analgesia, with marginal additional benefit if multimodal analgesic regimens including NSAIDs and acetaminophen are added. It was hypothesized by the authors that some of the limited benefit might be due to the fact that US-guided TAP blocks are primarily useful for somatic pain, but that major gynecologic surgery has a large visceral pain component. There are limited randomized studies involving Quadratus Lumborum block (QL) at this time. QL block has shown improved analgesia in abdominal operations as compared to TAP block and is thought to have potentially greater relief of visceral pain. There is a case report of motor weakness following anterior, lateral QL block for gynecologic laparoscopy, thought to be related to spread of the block to affect the L2 dermatome on one side. It has not been determined if this is a common occurrence or may be affected by the type of QL block performed.
Prior to this study, truncal regional anesthesia was used in the UAB Gynecology-Oncology Surgery Enhanced Recovery Program as an analgesic alternative for those who were not good candidates for intrathecal opioid injection. A comparison of QL block versus systemic lidocaine infusion or whether either of these interventions has utility over intrathecal opioid administration alone has yet to be described.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Eligible patients will undergo current standard enhanced recovery protocol (ERP) gyn-oncology protocol. All patients will receive intrathecal morphine as part of the existing ERP. They will then be randomized to receive; either lidocaine infusion, regional anesthesia truncal block (quadratus lumborum block), or intrathecal morphine alone. Patients will be randomized into either lidocaine (group 1), QL block (group 2), or intrathecal opioid alone (group 3) groups. There will be blinding of the patient and personnel involved in data collection, and patients will undergo either a posterior QL block with local anesthetic (group 2) or simulated QL block (groups 1 and 3; subcutaneous local anesthetic only) pre-operatively. All patients will also undergo a loading dose of lidocaine (groups 1) or saline (group 2 and 3) followed by continuous lidocaine infusion in the lidocaine group (group 1). Primary and secondary endpoints will be measured post-operatively.
入排标准
- 年龄范围
- 18 Years 至 69 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult patients undergoing gynecologic-oncology surgery involving a mid-line laparotomy incision and as part of the local ERP, who are initially identified as an outpatient
- •18 years of age or older
排除标准
- •Pregnancy,
- •Age >70,
- •Actual weight <65 kg
- •Severe COPD
- •Severe asthma
- •Other severe respiratory disease (ILD, etc.)
- •Local anesthetic allergy
- •History of cardiac arrhythmia or heart block
- •Use of oral anti-arrhythmia agents or lidocaine analogues (i.e. mexiletine)
- •Inability to be a candidate for intrathecal opioid injection based on medical history and provider judgement
研究组 & 干预措施
Lidocaine Bolus Infusion
Patients will also undergo a loading dose of lidocaine, followed by continuous lidocaine infusion in the lidocaine group.
Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively.
Patients will undergo a simulated QL block.
干预措施: Lidocaine Bolus Infusion (Drug)
Lidocaine Bolus Infusion
Patients will also undergo a loading dose of lidocaine, followed by continuous lidocaine infusion in the lidocaine group.
Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively.
Patients will undergo a simulated QL block.
干预措施: Saline Bolus Infusion (Drug)
Lidocaine Bolus Infusion
Patients will also undergo a loading dose of lidocaine, followed by continuous lidocaine infusion in the lidocaine group.
Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively.
Patients will undergo a simulated QL block.
干预措施: Simulated QL block (Procedure)
QL Block & Saline Bolus Infusion
Patients will undergo a posterior QL block.
Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively.
Patients will receive a saline bolus infusion.
干预措施: QL block (Procedure)
结局指标
主要结局
PACU Post-operative opioid consumption
时间窗: From 0 to 12 hours post surgery
Total opioid consumption (measured in oral morphine equivalents)
次要结局
- Length of PACU admittance to time of readiness for discharge from PACU(Time of PACU admittance to the time of PACU readiness for discharge, generally not more than 12 hours)
- PACU Sedation Scores(From 0 to 12 hours post surgery)
- Length of hospital stay(Time of admission until time of discharge, generally not over 1 week)
- Ambulation on POD 0 and POD1(From 0 to 96 hours post surgery)
- Return to bowel function(From 0 to 96 hours post surgery)
- Total Opioid Dose Utilized During Surgery(From one hour before surgery start time to one hour after procedure stop time)
- Presence or Absence of Patient Controlled Analgesia(From 0 to 96 hours post surgery)
- Time to First Opioid Use(From 0 to 96 hours post surgery)
- Average PACU Pain Score(From 0 to 12 hours post surgery)
- Post Operative Pain Scores(From 0 to 72 hours post surgery)
- Average PACU opioid consumption(From 0 to 12 hours post surgery)
- Post-operative opioid consumption(From 0 to 72 hours post surgery)
研究者
Prentiss Lawson
Principal Investigator
University of Alabama at Birmingham
