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Gall Bladder Bed Infiltration Analgesia

16. september 2020 opdateret af: Alaa Mazy Mazy

The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy

Early postoperative pain is a common complaint after elective laparoscopic cholecystectomy. Persistent acute postoperative pain is the dominating complaint and the primary reason for a prolonged stay after this procedure. This pain can be superficial incisional wound pain (somatic), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic), all of which may require systemic analgesia. Hypothesis: Laparoscopic pain can be superficial incisional wound pain (somatic pain), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic pain), so the block must be periportal for incisional wound pain, intraperitoneal to decrease pain caused by pneumoperitoneum, and of the bladder bed to decrease the deep visceral pain. This combination can give the maximum analgesia after laparoscopic cholecystectomy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Bladder bed irrigation with Bupivacaine was an effective method for reducing pain during the first postoperative hours after laparoscopic cholecystectomy. The intraperitoneal administration of lidocaine solution (total dose, 3.5 mg/kg) will be done as follows: immediately after creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space. In order to allow the sprayed solution to diffuse under the diaphragmatic space, the Trendelenburg position will be maintained for 2 minutes.

In the infiltration group will be administrating 5 ml lidocaine at each port site before incision, then the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space then 50 ml will be infiltrated in the bladder bed after clamping of the cystic duct and cystic artery. CO2 will be humidified and wormed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
    • Al-Dakahleia
      • Mansourah, Al-Dakahleia, Egypten, 35516
        • Gastro-enterolgy surgical center, Mansoura University

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

20 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Scheduled to undergo elective laparoscopic cholecystectomy.
  • American Society of Anesthesiologists physical status (ASA) I or II.

Exclusion Criteria:

  1. Patient in receipt of analgesics or sedatives 24 h before scheduled surgery.
  2. Patient with spillage or cholelithiasis with known common bile duct pathology.
  3. Body Mass Index > 40 Kg/m2.
  4. Patient underlying severe systemic disease.
  5. Patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: the infiltration group
a cocktail of 5 mg/Kg lidocaine normal saline in a volume of 3 ml/Kg 5 mcg/ml adrenaline. We will administrate 5 ml lidocaine at each port site before incision, then immediately after the creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space and another 50-75ml over the parietal peritoneum. The Trendelenburg position will be maintained for 2 minutes. Then 50 ml will be infiltrated in the bladder bed and pedicle after clamping of the cystic duct and artery. Infiltration will be through a laparoscopic suction needle, diameter 0.9 /330 mm (Zhejiang, China).
Medicin: the infiltration group
  • 15-20 ml periportal,
  • 50 ml in gallbladder bed,
  • The rest (about 150 ml in 70 Kg patient) will be intraperitoneal
Placebo komparator: the control group
the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.
Medicin: the control group
the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The total postoperative analgesic consumption
Tidsramme: postoperative, for 24 hours
ketorolac and morphine in mg .
postoperative, for 24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The time to the first request of analgesia
Tidsramme: postoperative, for 24 hours
hours
postoperative, for 24 hours
The intraoperative fentanyl requirements.
Tidsramme: intraoperative
microgram
intraoperative
postoperative pain score: VAS
Tidsramme: postoperative at 0, 2, 4, 8, 12, 16 and 24 hours
visual analog score from 0-10, zero is no pain, 10 is the most imaginable pain,
postoperative at 0, 2, 4, 8, 12, 16 and 24 hours
heart rate
Tidsramme: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
beat/ minute
basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
mean blood pressure
Tidsramme: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
mmHg
basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
incidence of vomiting
Tidsramme: postoperatively, during the first 24 hours
number
postoperatively, during the first 24 hours
the sleep quality
Tidsramme: postoperatively, after the first night.
through a score 0-2, where 0= good quite sleep, 1= fair sleep, 2= bad quality of sleep.
postoperatively, after the first night.
Patient satisfaction regards analgesia:
Tidsramme: postoperative after 24 hour.
using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.
postoperative after 24 hour.
Surgeon satisfaction regards the technique:
Tidsramme: postoperative within 1 hour.
using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.
postoperative within 1 hour.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alaa Mazy Mazy

Efterforskere

  • Studieleder: alaa mazy, MD, faculty of medicine, Mansoura

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)

10. september 2018

Primær færdiggørelse (Faktiske)

1. juni 2019

Studieafslutning (Faktiske)

11. juli 2019

Datoer for studieregistrering

Først indsendt

1. oktober 2018

Først indsendt, der opfyldte QC-kriterier

2. oktober 2018

Først opslået (Faktiske)

3. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2020

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MS.18.09.277

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