A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Technique Versus Laparoscopic Transversus Abdominis Plane Nerve Block Technique Versus No Block on Postoperative Opioid Consumption After Major Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- Morphine Requirement
研究概览
简要总结
Postoperative pain can pose significant challenges in the postoperative recovery of patients undergoing major colorectal surgery. Traditionally, opioids have played an important role in treating postoperative pain. It is well established that opioids are highly effective in relieving pain; however opioids are associated with numerous side effects that include nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus, drowsiness, sedation, and allergic reaction. These opioid side effects, which range in severity, can significantly interfere with discharge home following colorectal surgery. Significant interest exists in the use of local anesthetic based regional anesthesia techniques as a means to extend the analgesic window for patients undergoing colorectal surgery. Specifically, the use of the transversus abdominis plane (TAP) block as an adjunct in postoperative pain control has been widely reported in the anesthesia and colorectal surgery literature. Historically, the block was performed in a blind fashion with relative success and presently the block is typically performed either with ultrasound guidance or laparoscopic visualization. While TAP block has shown to be effective in post-operative pain control, the techniques used to place the block have not formally been compared.
The investigators are purposing a prospective, patient-blinded, randomized study of patients undergoing major colorectal surgery to compare TAP block under ultrasound guidance versus laparoscopic visualization versus no TAP block. The investigators hypothesize that laparoscopic-guided TAP block is non-inferior to ultrasound-guided TAP block with respect to perioperative pain control and either technique is superior to no TAP. In addition the investigators will measure procedural time, any adverse events related to the block, overall postoperative analgesic requirement, analgesic duration, postoperative pain scores, length of postoperative hospital stay, incidence of postoperative ileus, and overall patient satisfaction between the three groups.
详细描述
The proposed study is a patient-blinded, prospective randomized study to compare ultrasound-guided block of the TAP versus laparoscopic-guided TAP block versus no TAP block in patients undergoing major colorectal surgery. The primary outcome measure is analgesic requirement in morphine equivalents in the first 24 hours after surgery. Secondary outcome measures include overall postoperative analgesic requirement, postoperative pain scores, length of postoperative hospital stay, any adverse events related to TAP block, overall perioperative complications in the 30-day postoperative period and overall patient satisfaction after major colorectal surgery.
All groups will receive general anesthesia as the primary mode of anesthesia. Patients randomized to one of two treatment arms will also undergo either ultrasound-guided or laparoscopic-guided TAP block in the operating room at the conclusion of the procedure. Patients randomized to no TAP will not have a TAP block performed but will receive all routine intraoperative and postoperative analgesia as deemed appropriate by the anesthesia and primary surgical team. A standardized preoperative non-opioid pain regimen will be utilized. In the recovery room, short acting opioids for breakthrough pain will be available. Opioids will also be administered for rescue if need be. All patients will receive postoperative intravenous narcotics via patient controlled analgesia (PCA) device.
STUDY METHODS
I. Recruitment
- Patients of the investigators will be recruited for this study during their preoperative outpatient appointments approximately one week before surgery. The study material packet containing the HIPAA and the informed consent form will be emailed to the patient for review. Thus the patient will have adequate time to ask questions and consider the study prior to scheduled surgery.
- The patients will be contacted by one of the study investigators the morning of surgery at which time a signed consent will be obtained.
- Only patients who have provided their written consent and indicated that they have been introduced to the study prior to meeting with the anesthesiologists on the day of surgery will be able to participate.
- Screening procedures will make sure patients meet all inclusion criteria.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness and ability to sign an informed consent document
- •No allergies to anesthetic or analgesic medications
- •American Society of Anesthesia (ASA) physical status Class I - III adults of either sex
- •Aged 18-90 years
排除标准
- •Refusal to participate in the study
- •Age <18 or > 90 years
- •Contraindications to regional blockage including but not limited to:
- •Patient refusal to regional blockade
- •Infection at the site of needle insertion
- •Systemic infection
- •Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory evaluation)
研究组 & 干预措施
PLACEBO
No TAP block performed
干预措施: Placebo (Other)
US TAP Bupivacaine/Epinephrine
Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.
干预措施: US TAP Bupivacaine/Epinephrine (Drug)
Lap TAP Bupivacaine/Epinephrine
Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.
干预措施: Lap TAP Bupivacaine/Epinephrine (Drug)
结局指标
主要结局
Morphine Requirement
时间窗: 24 hours
Compare ultrasound-guided block of the transversus abdominis plane (TAP) vs laparoscopic-guided TAP block, versus no TAP block on opioid consumption in the first 24 hours. Patients hospital chart was queried for use of any intravenous opioid in the first 24 hours after surgery including fentanyl or hydromorphone and conversion to morphine per standard opioid dose conversion. Total morphine equivalents then summed for the 24 hour postoperative period and compared between groups.
次要结局
未报告次要终点
研究者
Karen Zaghiyan
Clinical Professor of Surgery
Cedars-Sinai Medical Center