- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02519023
TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy
Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
Andre navne:
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.
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Aktiv komparator: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Total Opioid Use for Pain Control
Tidsramme: 72 hours
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total opioid used from time 0 after surgery through 72 hours after surgery was complete.
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72 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)
Tidsramme: 0-72 hours post-procedure
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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.
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0-72 hours post-procedure
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Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
Tidsramme: 0-24 post-procedure
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0-24 post-procedure
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Quality of Recovery 15 (QoR15) Score
Tidsramme: 72 hours post-procedure
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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.
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72 hours post-procedure
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Overall Benefit of Analgesia Score (OBAS)
Tidsramme: 72 hours post-procedure
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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.
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72 hours post-procedure
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Number of Participants With Nausea and Vomiting
Tidsramme: 72 hours post-procedure
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72 hours post-procedure
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Length of Time in Phase 1 and Phase 2 of Recovery
Tidsramme: an expected average of 120 mins
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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.
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an expected average of 120 mins
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Number of Patients Admitted Post Operatively
Tidsramme: 72 hours post-procedure
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72 hours post-procedure
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Opioid Used From 24-48 Hours Post Surgery
Tidsramme: 24-48 hours after the end of surgery
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opioids in mg of morphine equivalents used from 24-48 hours after surgery
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24-48 hours after the end of surgery
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Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
Tidsramme: 48-72 hours after end of surgery
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opioid use from time 48-72 hours in mg morphine equivalents
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48-72 hours after end of surgery
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Patient Satisfaction With Pain Management
Tidsramme: at 72 hours after surgery
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number of patients who answered yes to if they were satisfied with their pain management
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at 72 hours after surgery
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Maximal Pain Score of Patient From Time 0-24 Hours After Surgery
Tidsramme: 0-24 hours after surgery
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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.
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0-24 hours after surgery
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Maximal Pain Score for Patient From Time 24-48 Hours After Surgery
Tidsramme: 24-48 hours after surgery
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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.
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24-48 hours after surgery
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Maximal Pain Score Patient Felt From 48-72 Hours After Surgery
Tidsramme: 48-72 hours after surgery
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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.
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48-72 hours after surgery
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
- Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
- Feierman DE, Kronenfeld M, Gupta PM, Younger N, Logvinskiy E. Liposomal bupivacaine infiltration into the transversus abdominis plane for postsurgical analgesia in open abdominal umbilical hernia repair: results from a cohort of 13 patients. J Pain Res. 2014 Aug 16;7:477-82. doi: 10.2147/JPR.S65151. eCollection 2014.
- Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Moller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.
- Singh M, Chin KJ, Chan V. Ultrasound-guided transversus abdominis plane (TAP) block: a useful adjunct in the management of postoperative respiratory failure. J Clin Anesth. 2011 Jun;23(4):303-6. doi: 10.1016/j.jclinane.2010.05.012.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Smerte
- Neurologiske manifestationer
- Akut smerte
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Autonome agenter
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Bedøvelsesmidler
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Antipyretika
- Adrenerge alfa-agonister
- Adrenerge agonister
- Analgetika, Opioid
- Narkotika
- Bedøvelsesmidler, lokale
- Bronkodilatatorer
- Anti-astmatiske midler
- Respiratoriske midler
- Adrenerge beta-agonister
- Sympatomimetika
- Vasokonstriktormidler
- Mydriatics
- Acetaminophen
- Bupivacain
- Ibuprofen
- Adrenalin
- Oxycodon
Andre undersøgelses-id-numre
- 7152222222
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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