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

14. ledna 2019 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

87

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Minnesota
      • Minneapolis, Minnesota, Spojené státy, 55455
        • University of Minnesota

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Ostatní jména:
  • Exparel
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.
Aktivní komparátor: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Total Opioid Use for Pain Control
Časové okno: 72 hours
total opioid used from time 0 after surgery through 72 hours after surgery was complete.
72 hours

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)
Časové okno: 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
Časové okno: 0-24 post-procedure
0-24 post-procedure
Quality of Recovery 15 (QoR15) Score
Časové okno: 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)
Časové okno: 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
Časové okno: 72 hours post-procedure
72 hours post-procedure
Length of Time in Phase 1 and Phase 2 of Recovery
Časové okno: 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
Časové okno: 72 hours post-procedure
72 hours post-procedure
Opioid Used From 24-48 Hours Post Surgery
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2016

Primární dokončení (Aktuální)

1. května 2017

Dokončení studie (Aktuální)

1. června 2017

Termíny zápisu do studia

První předloženo

28. července 2015

První předloženo, které splnilo kritéria kontroly kvality

5. srpna 2015

První zveřejněno (Odhad)

10. srpna 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. února 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. ledna 2019

Naposledy ověřeno

1. ledna 2019

Více informací

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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