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临床试验/NCT03105193
NCT03105193已完成4 期

Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections

University of Auckland, New Zealand1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年8月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Morphine consumption

研究概览

简要总结

The aim of this study is to investigate the analgesic effects of intraperitoneal lignocaine (IPL) compared with intravenous lignocaine (IVL) after laparoscopic colon resections. We plan to run a 2 group randomized, double blind, clinical trial which will look into morphine consumption as the primary outcome.

Group 1 (IV lignocaine)- IV bolus of lignocaine and a 3 day post operative IV lignocaine infusion. Intra peritoneal (IP) bolus of normal saline + 3 day post operative IP normal saline infusion

Group 2 (IP lignocaine)- IV bolus of normal saline and a 3 day post operative IV normal saline infusion. IP bolus of lignocaine + 3 day post operative IP lignocaine infusion

详细描述

Over the last 20 years, laparoscopic colonic surgery has become an accepted first-line treatment for colon cancer. A population-based study showed that laparoscopic colonic resections can be performed with lower hospital costs up to 90 days after discharge when compared to open surgery. Laparoscopic colonic resections have also been associated with fewer postoperative complications and lower mortality.

New Zealand has one of the highest rates of bowel cancer in the world, and it is the second highest cause of cancer deaths in New Zealand. With the implementation of a bowel screening programme in New Zealand, the projected numbers of stage 1 bowel cancers are expected to increase. More avenues to improve perioperative care need to be explored to improve patient outcomes.

Controlling postoperative pain effectively has been shown to reduce the length of hospital stay and improve patient/clinical outcomes. Opioids work as μ-receptor agonists in the spinal cord and brain, and although opioids are excellent at reducing pain, they are associated with nausea, vomiting, dizziness, decreased blood pressure, and urinary retention. Epidurals have been incorporated into Enhanced Recovery After Surgery protocols for controlling post-operative pain. However, epidurals are an invasive procedure with significant side effects such as hypotension, urinary retention, respiratory depression, motor blockade and rarely epidural abscess and meningitis. It has also been shown that up to 30 percent of epidural catheters dislodge, block or leak. These complications have led to a movement towards other regional analgesia techniques which allow local anaesthetic (LA) to target the abdominal wound specifically.

Intraperitoneal local anaesthetic (IPLA) has shown promise in reducing pain after colonic surgery with a meta-analysis9, and a recent IPLA colorectal study conducted at Counties Manukau health showing that it reduces pain and opioid use over and above the effect of an epidural10, which is primarily aimed at the abdominal wound. After an IPLA bolus serum local anaesthetic levels are detectable within 2 minutes. Some studies show reduced early postoperative pain and opioid consumption with intravenous lignocaine infusion alone. The question remains however if there is a benefit from using intraperitoneal local anaesthetic compared to administering it intravenously as the IPLA should block both the intraabdominal wound, via a local action, and the skin wound via a systemic action.. This has been investigated in four studies, however none of these studies compared intravenous local anaesthetic (IVLA) and IPLA for colon resection.

The aim is that, by optimising analgesia regimes using local anaesthetic, we can improve patient experience of pain and recovery thereby achieving an earlier discharge and early recovery from surgery. This has significant economic benefits for all involved.

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)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • consecutive consenting patients undergoing elective laparoscopic colonic resections will be recruited from surgical outpatient clinics at Manukau Super Clinic.

排除标准

  • under 16 years of age
  • acute colonic resection
  • those with ASA >= 4
  • previous adverse reaction/allergy to local anaesthetic,
  • surgery for rectal lesions which was defined as lesion within 15 cm of the anal verge
  • preoperative systemic steroid dependence
  • hepatic dysfunction, opioid use greater than 6 months
  • a diagnosis of Chronic Pain Syndrome
  • inability to consent or complete data scores in the study questionnaires due to cognitive impairment and/or language barrier.

研究组 & 干预措施

Intraperitoneal Lignocaine

Experimental

IP Lignocaine

干预措施: IV Saline bolus and infusion (Drug)

Intraperitoneal Lignocaine

Experimental

IP Lignocaine

干预措施: IP Lignocaine bolus and infusion (Drug)

Intravenous lignocaine

Experimental

IV lignocaine

干预措施: IP Saline bolus and infusion (Drug)

Intravenous lignocaine

Experimental

IV lignocaine

干预措施: IV lignocaine bolus and infusion (Drug)

结局指标

主要结局

Morphine consumption

时间窗: 3 days

Total morphine consumption at day 3

次要结局

  • Systemic Local Anesthetic Level(every morning post op starting day 1 until day 4 post op)
  • Length of stay(Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks)
  • Pain scores(0, 6, 12 hours and Postoperative day (POD) 1, 2, 3, 4 and 7)
  • Systemic Inflammatory Response (CRP and WBC)(very morning post op starting day 1 until day 4 post op)
  • Surgical recovery scores (SRS)(Up to 60 days post op)
  • Readmissions complications(30 days post op)
  • Return of bowel function(Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks)

研究者

发起方
University of Auckland, New Zealand
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS

Prof.

University of Auckland, New Zealand

研究点 (1)

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