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临床试验/NCT02400645
NCT02400645终止1 期

Comparison of Laparoscopically Assisted Transversus Abdominis Plane Block Using Liposomal Bupivacaine With Pre-incisional Bupivacaine for Post-operative Pain Control in Patients Undergoing Laparoscopic or Robotic Hysterectomy

University of Tennessee0 个研究点目标入组 69 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
69
主要终点
Visual Analog pain scores (VAS)

研究概览

简要总结

In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.

详细描述

Patients undergoing laparoscopic or robotic assisted total hysterectomy at Erlanger Hospital will be randomized into one of two groups to receive either laparoscopic assisted TAP block with liposomal bupivacaine and bupivacaine (Group A) or pre-incisional bupivacaine (Group B). The remaining aspects of the perioperative care, including the general anesthesia care and postoperative care will be similar for all patients. Ideally, patients will be informed and consented for the study in the preoperative clinic setting. They will be randomized in the pre-anesthesia care unit.

Patients in Group A will receive laparoscopic-assisted bilateral TAP blocks using 10cc liposomal bupivacaine, 10cc Bupivacaine 0.25% and 10cc Normal Saline one each side. Patients in Group B will receive a total of 20cc pre-incisional Bupivacaine divided between each of the trocar sites. All patients will receive Ketorolac 30 mg, IV at the conclusion of surgery. All patients will be offered either oral pain medications or patient controlled anesthesia (PCA) opiate pain medication as indicated. Morphine equivalents will be calculated.

Postoperative pain control will be assessed using Visual Analog Pain Score (VAS). This will be done by recovery room personnel who will be blinded as to whether the patients received TAP block or pre-incisional anesthetic. VAS will be assessed at rest at 1 hour and 2 hours after arrival to PACU. Patients will be assessed with Overall Benefit of Anesthesia Score (OBAS) questionnaires at postoperative days 1, 2 and 7. OBAS questionnaires will be done by personnel blinded to anesthesia technique. Patients will also be blinded as to which group they were in. Total morphine equivalents of intraoperative and postoperative pain medications will be calculated through postoperative day 7.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA physical status 1-3,
  • Scheduled for laparoscopic or robotic assisted laparoscopic hysterectomy,
  • Able to participate personally or by legal representation in informed consent

排除标准

  • History of relevant allergy to the study drugs (Bupivacaine),
  • Chronic opioid use or drug abuse history,
  • Inability to understand the study protocol,
  • Refusal to provide written consent,
  • Soft tissue infection of the abdominal wall and skin

研究组 & 干预措施

Group A: pre-incisional bupivacaine

Active Comparator

Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.

干预措施: Pre-incisional wound infiltration (Procedure)

Group A: pre-incisional bupivacaine

Active Comparator

Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.

干预措施: Bupivacaine (Drug)

Group A: pre-incisional bupivacaine

Active Comparator

Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.

干预措施: Ketorolac (Drug)

Group B: laparoscope to place TAP block

Active Comparator

Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.

干预措施: Laparoscope to place TAP block with liposomal bupivacaine (Procedure)

Group B: laparoscope to place TAP block

Active Comparator

Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.

干预措施: Liposomal bupivacaine (Drug)

Group B: laparoscope to place TAP block

Active Comparator

Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.

干预措施: Bupivacaine (Drug)

Group B: laparoscope to place TAP block

Active Comparator

Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.

干预措施: Ketorolac (Drug)

结局指标

主要结局

Visual Analog pain scores (VAS)

时间窗: Two hours

1. Postoperative pain at 1 hour and 2 hours after arrival to recovery using Visual Analog Pain Scores (VAS) 2. VAS: 0 (no pain) TO 10 (worst possible pain)

次要结局

  • Narcotic pain medication usage(2 hours postoperative)
  • Narcotic pain medication following surgery(1 week)

研究者

申办方类型
Other
责任方
Sponsor

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