Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery
18. juni 2019 opdateret af: Icahn School of Medicine at Mount Sinai
The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients
This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The goal of the study is to investigate acupuncture at the time of gynecological surgery as a way to decrease post-operative pain which would decrease narcotic intake and hospitalization time.
To do this, the researchers will recruit non-pregnant patients over the age of 18 who are undergoing laparoscopic surgery for a benign gynecological indication.
These patients will be randomized using a computer generated randomization system to receive either acupuncture or sham acupuncture pre-operatively after the induction of anesthesia.
The acupuncture points used will be points proven in the literature to be associated with decreasing general pain, pelvic pain and nausea and vomiting.
The needles will be placed by a anesthesiologist trained in acupuncture and they will be left in place for 15 minutes while the patient is prepped for the surgery.
The sham points will be on the hands and feet and chosen at random by the gynecologic surgeon who is not trained in acupuncture.
For both groups, the acupuncture needles will be removed before the first incision of the surgery.
All patients will be blinded to their group allocation.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
110
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
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New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- female patients
- over the age of 18
- scheduled for laparoscopic gynecological procedures for benign conditions of the uterus, fallopian tubes and/or adnexa
Exclusion Criteria:
- male patients
- pregnancy
- suspected or known malignant disease
- immunocompromised
- known or persistent abuse of medications, drugs or alcohol
- chronic pain for greater than 3 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Acupuncture
Receives acupuncture during gynecological surgery at 5 known points for pain control.
Needles will be placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient is prepped for surgery.
They will be in place for 15 minutes.
|
Acupuncture needles (29 and 30 gauge) used to perform the acupuncture
|
|
Sham-komparator: Sham acupuncture
Receives acupuncture during gynecological surgery at sham points not associated with pain control.
Needles will be placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery.
The needles will be removed immediately after placement.
|
Acupuncture needles (29 and 30 gauge) used to perform the acupuncture
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Morphine Equivalent Usage While in the Hospital
Tidsramme: Intra-operative and 24 hours post-operatively
|
Effectiveness of intra-operative acupuncture in post-operative pain control as measured by narcotic use in the 24 hours post-operatively.
Narcotic use monitored either through hospital records if patient is still admitted to the hospital or over the phone if the patient is discharged home prior to 24 hours post-operative.
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Intra-operative and 24 hours post-operatively
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Pain Medication Tablets Used at Home Post-Operatively
Tidsramme: 7 days post-operatively
|
Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.
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7 days post-operatively
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Number of Patients Readmitted to the Hospital
Tidsramme: 2 weeks post-operatively
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Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.
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2 weeks post-operatively
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Pain Score
Tidsramme: up to 4 hours post operatively
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Pain Score.
Patients asked to rate pain score total from 0-10 with higher score indicating more pain
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up to 4 hours post operatively
|
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Pain Score at Home Post-Operatively
Tidsramme: up to 7 days post operatively
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Pain Score from 0-10 with higher score indicating more pain
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up to 7 days post operatively
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Charles Ascher-Walsh, MD, Icahn School of Medicine at Mount Sinai
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. august 2016
Primær færdiggørelse (Faktiske)
5. december 2017
Studieafslutning (Faktiske)
5. december 2017
Datoer for studieregistrering
Først indsendt
29. juli 2016
Først indsendt, der opfyldte QC-kriterier
1. august 2016
Først opslået (Skøn)
4. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. juni 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2019
Sidst verificeret
1. juni 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCO 16-1120
Plan for individuelle deltagerdata (IPD)
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