Transversus Abdominis Plane Blocks for Ileostomy Takedown: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- 24 Hour Postoperative Opioid Consumption
研究概览
简要总结
Consenting subjects will be randomized to receive injection of bupivacaine or placebo before surgery for ileostomy takedown (injection administered after general anesthesia has been administered). Pain and side effects will be assessed periodically after surgery using the verbal Numeric Rating pain Scores, including at the timepoint of 24 hours after surgery. All subjects in this study will be given toradol to ensure adequate pain control.
详细描述
Subject Enrollment
The charts of patients who are scheduled for ileostomy takedown surgery will be screened for eligibility the day before surgery by an investigator on this study. On the day of surgery, patients will be seen in their pre-operative holding area by a member of their anesthesia team or the acute pain team. They will be screened for eligibility for anesthesia and surgery. Once they are cleared for the operating room they will be seen by a resident, fellow, or attending for the acute pain service, who is an investigator on this study, to confirm eligibility for this study. A peripheral intravenous line will also be placed as is standard for the operating room. If it has been determined that they meet eligibility criteria they will have further discussion with the clinical trials coordinator or an investigator to determine if the patient would like to participate in this study. If they would like to proceed as a subject in this study they will be consented. The consent process will take place in a semi-enclosed space used in preoperative holding to consent for surgical procedures and anesthesia. Study investigators or coordinators will conduct the consent process.
Conduct of Study
Study Procedure Overview
The nurses will check the patient into the preoperative holding area and collect usual preoperative information. Once the patient has consented to be a part of this study they will be brought to the block room. Standard monitors will be placed and a time- out procedure will be performed, as is standard for all procedures which take place in the block room. Side of procedure will be verified. At this time the subject will be randomized to receive TAP block or placebo by random computer generated assignment that is in a sealed envelope. The study solution will be prepared by the regional anesthesiologist performing the procedure. The subject will receive sedation with midazolam and versed titrated to effect as is standard for all block placements. The subjects' abdomen on the side ipsilateral to the ileostomy will be sterilely prepared. The ultrasound will have a sterile dressing placed over the probe and a standard 21 gauge or 22 gauge b-bevel, 10 cm block needle will be flushed with the study solution. A syringe of 1% lidocaine will also be prepared to anesthetize the skin prior to insertion of the block needle. The ultrasound will be placed on the abdomen. Once a good view of the 3 muscle layers of interest is visualized (internal oblique, external oblique and transverses abdominis) the probe will be held still and the 1% lidocaine will be used to numb the skin. The block needle will be placed "in line" with the probe so that the entirety of the needle may be visualized during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having an ileostomy takedown alone, on one side of abdomen
- •Ages 18-80 inclusive
- •English speaking
- •BMI less than 40
- •Ability to understand verbal pain scale
- •American Society of Anesthesiologists (ASA) Physical Status 1-3
排除标准
- •Allergy to local anesthetics
- •History of recent/current local or generalized infection
- •Immunocompromised
- •Significant psychiatric disease
- •History of opioid dependence
- •Pregnancy or lactation
- •A prisoner.
- •Significant liver disease
- •Contraindication to ondansetron or dexamethasone
- •Clinically significant cardiac or pulmonary disease
研究组 & 干预措施
TAP block group
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
干预措施: Transversus abdominis plane block (Procedure)
Placebo
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
干预措施: Transversus abdominis plane block (Procedure)
结局指标
主要结局
24 Hour Postoperative Opioid Consumption
时间窗: 24 hours
We aim to evaluate whether patients consume less opioids, over the first 24 hours post-operatively following ileostomy takedown, with the addition of a pre-operative Transversus Abdominis Plane (TAP) block for analgesia.
次要结局
- Time to Hospital Discharge(Hours that patient spends in the hospital for their surgical procedure.)
- Pain Scores at 24 Hours Post-block(24 hours post-block)
- Time From PACU Recovery Room Admission Until Meeting Recovery Room Discharge Criteria(Approximately two hours post-anesthesia)
- Incidence of Post-operative Nausea(24 hours)
- Pain Scores at Post-anesthesia Care Unit (PACU) Discharge(Surgical PACU (Approximately 2 hours post-anesthesia))
- Intra-operative Opioid Use(Approximately 2-3 hours after block/placebo placement)
- PACU Opioid Use(Approximately two hours post-anesthesia)