Maneuvers to Reduce Laparoscopic Pain
Optimal Maneuver to Reduce Postoperative Pain Following Elective Laparoscopic Surgeries
Laparoscopic surgery has revolutionized surgical care by reducing morbidity and improving post operative recovery. Laparoscopic surgery involves the use of carbon dioxide for insufflation to achieve optimal visualization. There is literature that demonstrates higher insufflation pressures being associated with increased postoperative pain - particularly shoulder pain - and opioid use1-3. The ideal amount of intraperitoneal pressure is still under debate as other studies demonstrate that reduced pneumoperitoneum insufflation has also shown to negatively impact surgeon satisfaction and trended with longer operative time and greater blood loss without impacting pain4.
Residual intraperitoneal carbon dioxide can also contribute to postoperative discomfort. Studies have shown the effectiveness of various maneuvers in removing residual gas to reduce postoperative pain, such as intraperitoneal saline instillation5, pulmonary recruitment6,7, and gas aspiration via smoke evauator8.
Despite these advantages, there is a lack of a clear consensus on the optimal method for reducing residual intraperitoneal gas. Conversely, literature has mixed results regarding the true significance in pain reduction3,5,9.
Given the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, we propose a prospective, patient-blinded, randomized controlled trial. We aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain. We hope our findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Michigan
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Detroit, Michigan, Spojené státy, 48202
- Henry Ford Hospital
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Kontakt:
- Ilinca Lupea, MD
- Telefonní číslo: 3134254567
- E-mail: ilupea1@hfhs.org
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Vrchní vyšetřovatel:
- Ilinca Lupea, MD
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Patients age 18 to 65
- Benign, elective laparoscopic surgeries
Exclusion Criteria:
- Ages <18 and age >65
- Emergency or urgent surgeries
- Surgeries for chronic pelvic pain, malignancy
- Surgeries during pregnancy
- Severe cardiopulmonary disease
- Prior extensive abdominal surgeries (more than 2 abdominal or pelvic surgeries)
- Inability to consent
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Smoke Evacuation Group
Active gas removal via smoke evacuator for 30 seconds at the end of case
|
the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, we propose a prospective, patient-blinded, randomized controlled trial.
We aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain.
We hope our findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.
|
|
Experimentální: Recruitment Breath Group
Repeated pulmonary inflation maneuvers: 3 consecutive manual ventilations at maximum of 30 cm H2O at the end of case
|
the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, we propose a prospective, patient-blinded, randomized controlled trial.
We aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain.
We hope our findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.
|
|
Komparátor placeba: Control Group
Passive desolation of the pneumoperitoneum at the end of the laparoscopic surgery
|
the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, we propose a prospective, patient-blinded, randomized controlled trial.
We aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain.
We hope our findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Post operative pain
Časové okno: From enrollment until 1 week post surgery
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Post-operative pain: Patients will be assessed using the Numeric Rating Scale (NRS) by rating their pain on a scale from 0 (no pain) to 10 (worst pain imaginable) immediately prior to leaving the post-anesthesia care unit, on post-operative day 2, and post-operative day 7.
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From enrollment until 1 week post surgery
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Opioid use for the management of post operative pain
Časové okno: Time of enrollment until their post operative appointment up to 2 weeks from the time of surgery
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Opioid use: Patients will be asked how many of the opioid pain medication pills they were discharged with were consumed, at either their 2-week post-operative in-person visit or phone call question.
Patients will be instructed to either count the number of pills that were taken or bring the bottle to their visit.
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Time of enrollment until their post operative appointment up to 2 weeks from the time of surgery
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 18542-01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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