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临床试验/NCT05672680
NCT05672680已完成2 期

Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Pain Score at Rest

研究概览

简要总结

The aim of this double-blind clinical trial is to examine outcomes and pain control after surgery in patients who underwent laparoscopic inguinal hernia repair (IHR) with the use of perioperative transabdominal plane (TAP) block.

Research Question: Does transabdominal plane block improve pain when undergoing inguinal hernia repair? The endpoints include whether preoperative TAP blocks improve pain score (primary end point) and decrease opioid use (secondary endpoint) after an inguinal hernia repair. Other end points- complications after surgery.

详细描述

Protocol:

After receiving approval for the study, the researchers will conduct a prospective single institution randomized clinical trial assessing if using a TAP block perioperatively can reduce pain scores after surgery. Other endpoints include whether there are differences in pain medication usage and complications.

Patients will be screened by research team members and attending surgeons. If the patient is interested, the researchers will consent the participants for the study after understanding the study details, procedures, and expectations. The researchers will then consent using IRB approved study consent forms and procedures. Patients will undergo a laparoscopic inguinal hernia repair according to standard procedures. The study will assess if a TAP block impacts pain scores. Patients will be randomized to receive the intervention or placebo. Sequentially numbered sealed opaque envelopes with group allocation inside will alert the anesthesiologist & surgeon to order Tap block composed of 0.25% bupivacaine or placebo (normal saline).

Inguinal hernia repair will be performed in standard fashion that each individual surgeon is familiar with. No additional tests or blood work outside the standard of care for IHR will be performed for research purposes. In addition, some patients will be given TAP blocks before surgery to help in pain management. Patients will be discharged with a worksheet on which the participants are to record analgesic use and pain scores on postoperative days one, two, three and four. The participants are expected to bring the completed log to their two-week follow up visit with their surgeon. Patients may also expect to receive a phone call from a member of the surgical team to remind them to record these metrics.

The TAP block is done pre-procedure using 0.25% bupivacaine. If patients weigh<100 kg, the patients will receive a total of 50 ml (25 ml on each side of the abdominal wall). If patients weigh>100 kg, the patients will receive a total of 60 ml (30ml on each side of the abdominal wall). The TAP plane is identified using ultrasound. All anesthesiologists (not surgeons) working with the attendings involved in this study have been trained in this technique; it is a routine part of their practice. It is anesthesiologists who will be performing the block.

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

入选标准

  • Patients undergoing laparoscopic inguinal hernia repair at the Mount Sinai Hospital

排除标准

  • patients who are younger than 18 years old,
  • have a history of chronic opiate usage, liver or kidney disease, pain syndromes,
  • allergy to bupivacaine,
  • are pregnant or
  • are unable to independently give consent

研究组 & 干预措施

Placebo

Placebo Comparator

Normal Saline:

For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

Normal Saline:

For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.

干预措施: TAP block (Procedure)

Experimental

Experimental

0.25% bupivacaine: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.

干预措施: 0.25% Bupivacaine (Drug)

Experimental

Experimental

0.25% bupivacaine: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.

干预措施: TAP block (Procedure)

结局指标

主要结局

Pain Score at Rest

时间窗: All post-op (average 4 days)

On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain.

Pain Score at Movement

时间窗: All post-op (average 4 days)

On the pain score instrument, patients will score their pain score at movement. The full scale is scored between 1-10, with higher score indicating more pain.

次要结局

  • Number of Patients Per Anesthesiologist(during procedure)
  • Number of Opioid Pills(All post-op (average 4 days))
  • Number of Non-opioid Pain Medication(All post-op (average 4 days))
  • Number of Intraoperative Complications(up to 2 weeks post-surgery)
  • Number of Participants With Contents in the Hernia(during procedure)
  • Number of Surgical Tacks Used Per Repair(during procedure)
  • Procedure Time(during procedure)
  • Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss(during procedure)

研究者

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

Celia M. Divino

The Edelman Professor of Surgery

Icahn School of Medicine at Mount Sinai

研究点 (1)

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