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临床试验/NCT05432934
NCT05432934招募中1 期

Transversus Abdominis Plane Blocks With and Without Dexamethasone: A Randomized Clinical Trial in Minimally Invasive Colorectal Surgery

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Total postoperative opioid consumption in the first 48 hours after surgery (hydromorphone equivalents.

研究概览

简要总结

Dexamethasone will be used as an adjunct to local anesthetics (bupivacaine) to prolong the duration of laparoscopically-placed transversus-abdominis plane blocks in elective colorectal resection.

详细描述

Advances in minimally invasive surgery have reduced postoperative morbidity and enhanced recovery. Despite increased use of minimally invasive techniques, postoperative pain remains a challenging aspect of surgical treatment of colorectal diseases and is typically treated with multimodal analgesia, yet the backbone of analgesia continues to be opioid therapy. As analgesics, opioids are effective but fraught with side effects, including delay in return of bowel function, sedation, and potential for dependency.

Minimally invasive colorectal surgery has dramatically improved postoperative outcomes, resulting in significantly shorter length of stay, pain, and overall cost. Despite the advances in multimodal analgesia and enhanced-recovery pathways, the optimal strategy for perioperative analgesia has not yet been defined, and there may be a role for expanded use of regional anesthesia in minimally invasive surgery.

Regional anesthesia, specifically the transversus abdominis plane block, has been shown to reduce postoperative pain and opioid requirements even in the context of minimally invasive surgery. Surgeon-performed, laparoscopically placed TAP blocks are equivalent, or perhaps superior, to ultrasound-guided TAP blocks . Long-acting local anesthetics, specifically liposomal bupivacaine, have been shown to prolong the effect of TAP blocks over non-liposomal bupivacaine , and has also suggested a reduced length of stay and less overall cost, despite the high cost of the formulation. These findings suggest improved outcomes can be expected if a longer block is achieved.

Liposomal bupivacaine is not available and Canada and is very costly. Regional anesthetic supplemented with dexamethasone, a potent corticosteroid, has shown improved efficacy and prolonged duration of anesthetic in other regional anesthetic techniques. The investigators hypothesize that addition of dexamethasone to bupivacaine can prolong the duration of block to be similar to that achieved with liposomal bupivacaine, but at a much lower cost.

Ample evidence exists validating TAP block as an effective adjunct to minimally invasive surgery. Robust data also support the additional benefit of dexamethasone in regional anesthesia. No studies have been published specifically assessing any benefit of combining dexamethasone with local anesthetic to improve the TAP block, and none can be found registered at clinicaltrials.gov. This will be the first such trial to evaluate a promising technique that could reduce postoperative pain and opioid requirements. If found to be effective, this technique would profoundly impact surgical practice around the world.

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, Care Provider)

入排标准

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

入选标准

  • age > 18
  • ASA class I-III
  • elective or urgent inpatient laparoscopic/laparoscopic assisted colorectal surgery.

排除标准

  • emergency surgery
  • open surgery
  • contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum)
  • ASA class 4
  • age < 18
  • pregnant or breastfeeding women
  • significant cardiorespiratory/hepatic/renal disease
  • allergy to any study drugs
  • inability to consent
  • inability to respond to pain assessments
  • inability to use the patient-controlled analgesia device (PCA)
  • preoperative chronic opioid use

研究组 & 干预措施

Dexamethasone

Experimental

Dexamethasone 16mg will be added to local anesthetic solution for TAP blocks. 4mg will be injected at 4 anterior abdominal wall sites in a laparoscopically-administered TAP block. This is a single intraoperative dose.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Total postoperative opioid consumption in the first 48 hours after surgery (hydromorphone equivalents.

时间窗: 48 hours

次要结局

  • Opioid consumption in the post-anesthetic care unit (PACU)(48 hours)
  • Length of stay in hospital (days).(3-7 days)
  • Length of stay in post-anesthetic care unit (minutes).(60-120 minutes)

研究者

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

Nathan Ginther

Assistant Professor

University of Saskatchewan

研究点 (1)

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