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TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy

2019年1月14日 更新者:University of Minnesota

Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy

Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. To augment this pain there are many different analgesic techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP) block is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet different analgesic approach is that of direct injection of local anesthetic into the incision by the surgeon during or just after surgical procedures. These two approaches have both been proven to decrease post-operative pain in patients for many procedures, but never compared to one another.

調査の概要

詳細な説明

This is a double blinded randomized study. All patients will receive one form of local anesthetic pain relief either from TAP or infiltration. Patients will be randomized to one of two study arms in a double-blinded, placebo controlled study. All patients will receive a TAP infiltration and all patients will receive infiltration into the incision.

In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.

In the second arm the bilateral TAP infiltration will consist of 30 mL of normal saline per side. In the same arm the surgeon infiltration will consist of 10 mL of 0.25% bupivacaine per port site. The surgeon infiltration will consist of 5 ml of 0.25% bupivacaine prior to incision and 5 ml of 0.25% bupivacaine prior to closure at each port site.

A TAP infiltration is an injection of local anesthetic under the covering of the transversus abdominis muscle layer which provides effective post operative analgesia.2-5 This layer is found using an ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound the investigators can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is infiltrated into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and facial layers of the abdomen. This is currently standard of care at our institution and will be performed within one hour of surgical incision. The injection will consist of 10 mL of 0.25% bupivacaine with epinephrine followed by 20 mL of liposomal bupivacaine saline mixture or 10 ml of saline followed by 20 ml of saline and then repeated on the contralateral side.

Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.

Investigational Drug Service (IDS) pharmacy will be charged with the blinding of medications vs. saline for these procedures.

Following the procedure, all individuals will receive scheduled acetaminophen (1 gram every 6 hours), scheduled ibuprofen (800 mg every 8 hours), and PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.

研究の種類

介入

入学 (実際)

87

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55455
        • University of Minnesota

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Inclusion Criteria:

  • ASA physical status I-III
  • Females >/=18-years of age
  • Scheduled for laparoscopic/robot-assisted hysterectomy.

Exclusion Criteria

  • Contraindication to surgical infiltration or regional blockade
  • History of long term opioid intake (greater than 3 weeks prior to surgery) or chronic pain disorder
  • Inability to understand the informed consent and demands of the study
  • Surgery scheduled to start after 1700

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的:TAP-Block with liposomal bupivacaine
TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.
In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side.
他の名前:
  • エクスパレル
An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane
TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine.
all individuals will receive scheduled acetaminophen (1 gram every 6 hours),
all individuals will receive scheduled ibuprofen (800 mg every 8 hours)
all individuals will receive PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.
アクティブコンパレータ:Surgical infiltration with bupivacaine
Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.
An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane
all individuals will receive scheduled acetaminophen (1 gram every 6 hours),
all individuals will receive scheduled ibuprofen (800 mg every 8 hours)
all individuals will receive PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.
Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Total Opioid Use for Pain Control
時間枠:72 hours
total opioid used from time 0 after surgery through 72 hours after surgery was complete.
72 hours

二次結果の測定

結果測定
メジャーの説明
時間枠
Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)
時間枠:0-72 hours post-procedure
the Numerical rating scale goes from 0 (lowest) to 10 (highest). Higher values are a worse outcome. The maximal number for maximal pain scores from 0-72 hours is 30. Thus the range for this outcome is 0 to 30 with 30 being a worse outcome. This is because the 0-72 hour maximal pain scores are additive from the 0-24, 24-48, and 48-72 hours. Each 24 hour subset has a maximal score of 10 and adding all three results in maximal score of 30.
0-72 hours post-procedure
Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
時間枠:0-24 post-procedure
0-24 post-procedure
Quality of Recovery 15 (QoR15) Score
時間枠:72 hours post-procedure
The quality of recovery is a survey given to patients. It is 15 questions. The scale of the QOR 15 Score is 0 to 150. 150 is a better outcome.
72 hours post-procedure
Overall Benefit of Analgesia Score (OBAS)
時間枠:72 hours post-procedure
The overall benefit of analgesia score is based off 7 questions given to patients it is scored 0-28. 28 is considered a worse outcome.
72 hours post-procedure
Number of Participants With Nausea and Vomiting
時間枠:72 hours post-procedure
72 hours post-procedure
Length of Time in Phase 1 and Phase 2 of Recovery
時間枠:an expected average of 120 mins
time from start of recovery until patient was deemed ready to discharge from phase 2 recovery. Phase 2 recovery is the phase of the post anesthesia care where patients are readied to be discharge form the post anesthesia care unit. There are guidelines with regards to when patients are able to be discharged and when those points are met by the patient they are deemed ready to discharge.
an expected average of 120 mins
Number of Patients Admitted Post Operatively
時間枠:72 hours post-procedure
72 hours post-procedure
Opioid Used From 24-48 Hours Post Surgery
時間枠:24-48 hours after the end of surgery
opioids in mg of morphine equivalents used from 24-48 hours after surgery
24-48 hours after the end of surgery
Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
時間枠:48-72 hours after end of surgery
opioid use from time 48-72 hours in mg morphine equivalents
48-72 hours after end of surgery
Patient Satisfaction With Pain Management
時間枠:at 72 hours after surgery
number of patients who answered yes to if they were satisfied with their pain management
at 72 hours after surgery
Maximal Pain Score of Patient From Time 0-24 Hours After Surgery
時間枠:0-24 hours after surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
0-24 hours after surgery
Maximal Pain Score for Patient From Time 24-48 Hours After Surgery
時間枠:24-48 hours after surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
24-48 hours after surgery
Maximal Pain Score Patient Felt From 48-72 Hours After Surgery
時間枠:48-72 hours after surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
48-72 hours after surgery

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年7月1日

一次修了 (実際)

2017年5月1日

研究の完了 (実際)

2017年6月1日

試験登録日

最初に提出

2015年7月28日

QC基準を満たした最初の提出物

2015年8月5日

最初の投稿 (見積もり)

2015年8月10日

学習記録の更新

投稿された最後の更新 (実際)

2019年2月8日

QC基準を満たした最後の更新が送信されました

2019年1月14日

最終確認日

2019年1月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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