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Comparison of Intraperitoneal Bupivacaine and Saline Irrigation for Pain Relief After Laparoscopic Cholecystectomy

13. juni 2026 opdateret af: Wah Medical college , POF hospital

Comparison of Intraperitoneal Bupivacaine and Normal Saline Irrigation for Postoperative Pain Relief After Laparoscopic Cholecystectomy

This randomized clinical trial compared intraperitoneal irrigation of bupivacaine(a local anesthetic) vs a control group receiving normal saline for relief of post operative pain following laparoscopic gallbladder surgery. A total of 106 patients divided into two equal groups, with one group receiving bupivacaine and the other treated using normal saline(control).Previous studies on the subject found that bupivacaine significantly reduced postoperative pain. Although conventional intravenous analgesics remain widely used, bupivacaine may be a better option, especially in difficult surgical cases.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

This randomized clinical trial was conducted to compare the effectiveness of intraperitoneal bupivacaine and normal saline for relief of post operative pain following laparoscopic cholecystectomy. A total of 106 patients undergoing elective laparoscopic gallbladder surgery were enrolled and randomly assigned into two equal groups. Non-probability consecutive sampling technique will be used to recruit patients.Patients with clinical findings of choledocholithiasis/pancreatitis/cholecystitis, who need intraoperative conversion to an open procedure, are pregnant or lactating, do not have the capacity to express pain, or have any contraindication to the drugs under study, will be excluded.In Group A, the patients received intraperitoneal irrigation of bupivacaine , while in Group B, only normal saline was used. The standard procedure of laparoscopic cholecystectomy will be similar in both groups, except for the difference that group A patients will undergo intraperitoneal instillation of 500ml normal saline solution, whereas those allocated into group B will have peritoneal irrigation using 20ml of 10% bupivacaine solution diluted in 480ml of normal saline to make a 500ml irrigation solution at the time of peritoneal closure. To ensure double blinding, the primary surgeon and patient will be blinded to the type of solution used. The time of extubation will be noted, which will be used to determine the duration of analgesia. Patients will be followed up for VAS scores at time intervals of 1, 2, 4, 6, 12, and 24 hours postoperatively. When the patient complains of pain, intravenous tramadol of 37.5mg mixed with an antiemetic will be administered.To reduce confounding, all procedures are done by the same consultant surgeon; no additional postoperative analgesic advised, and a blinded surgeon will evaluate the patient for the pain scores at these intervals, with due recording of the dosages of rescue analgesics and duration of analgesia.Past literature has provided some insight into the efficacy of bupivacaine in reducing postoperative pain, but existing evidence is not enough to establish clinical practice guidelines. Our study has the rationale of strengthening the existing body of evidence by extending the research.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

106

Fase

  • Fase 4

Kontakter og lokationer

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Studiekontakt

Studiesteder

    • Punjab Province
      • Wāh, Punjab Province, Pakistan, 47040
        • Rekruttering
        • Wah Medical College, POF Hospital Wah cantt Wāh
        • Kontakt:
        • Ledende efterforsker:
          • Muhammad asad Janjua, MBBS

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

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • • Adult consented patients of any gender aged 18 to 60 years Fit to undergo elective laparoscopic cholecystectomy

Exclusion Criteria:

  • • Patients who had developed choledocholithiasis or pancreatitis pre-operatively

    • Where conversion to open cholecystectomy is needed intraoperatively
    • Pregnant or lactating
    • Inability to express pain appropriately, like in psychiatric disorders
    • With any contraindication to the use of bupivacaine or normal saline, e.g., hypersensitivity

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental : group A: bupivacaine
Group A is the arm where patients have received intraperitoneal bupivacaine during laparoscopic gallbladder surgery, and their post operative pain is compared .
In group A intraperitoneal bupivacaine is used for pain relief
Andre navne:
  • Gruppe A
Placebo komparator: Placebo : group B: saline
Placebo : group B: saline Group B is the arm where patients have received only intraperitoneal normal saline .
In group B intraperitoneal saline is used for pain relief as placebo.
Andre navne:
  • Gruppe B

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post operative pain relief
Tidsramme: From the completion of the procedure til one hour after surgery
The study primarily aimed to compare post operative pain relief following intraperitoneal irrigation of bupivacaine vs normal saline.
From the completion of the procedure til one hour after surgery

Samarbejdspartnere og efterforskere

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

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 (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

6. juni 2026

Først indsendt, der opfyldte QC-kriterier

13. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

1 year after publication of article in journal

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • CSR

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Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Bupivacain

Abonner