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Intraperitoneal Ketamine Versus Fentanyl as Adjuvants to Bupivacaine in Laparoscopic Cholecystectomy

23. juni 2026 opdateret af: Tarek Mohamed Essa Tohamy, Assiut University

Intraperitoneal Instillation of Ketamine Versus Fentanyl as Adjuvants to Bupivacaine for Postoperative Pain Control in Laparoscopic Cholecystectomy _a Double-blinded Randomized Trial.

Laparoscopic cholecystectomy is the standard surgical treatment for gallbladder stones; however, the origin of pain after LC is multifactorial and complex in nature. Pain arising from incision sites is parietal pain, whereas pain from the gall bladder bed is mainly visceral in nature, and shoulder pain is mainly referred owing to the residual carbon dioxide irritating the diaphragm. Intraperitoneal administration of local anesthetics has been shown to improve postoperative pain control and reduce the need for systemic analgesics. The addition of adjuvant agents such as fentanyl or ketamine may further enhance analgesic efficacy. This randomized double-blind study aims to compare the effectiveness of intraperitoneal ketamine versus fentanyl as adjuvants to bupivacaine in reducing postoperative pain and analgesic requirements following laparoscopic cholecystectomy.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

Laparoscopic cholecystectomy (LC) is widely recognized as the gold standard for the treatment of gallbladder stones due to its significant advantages over the conventional open surgical approach. These benefits include faster postoperative recovery, reduced surgical morbidity, shorter hospital stay, and decreased postoperative pain. Despite these advantages, postoperative pain remains a major concern and is considered one of the primary factors affecting patient comfort and delaying discharge following surgery. Abdominal pain is usually most pronounced during the first 24 hours after the procedure, while shoulder pain commonly develops on the second postoperative day as a consequence of diaphragmatic irritation caused by residual carbon dioxide. Because postoperative pain after laparoscopic surgery is multifactorial in origin, a multimodal analgesic approach is widely recommended . Various strategies have been employed to improve pain control, including the use of local anesthetics administered alone or in combination with intraperitoneal opioid analgesics. Intraperitoneal (I.P.) administration of local anesthetics has become a popular and effective technique for postoperative pain management, as it can reduce the need for systemic analgesics and minimize the adverse effects associated with nonsteroidal anti-inflammatory drugs and opioids. This approach was first investigated in gynecological laparoscopic procedures and has since been extensively studied in patients undergoing LC. Several studies have demonstrated that the addition of adjuvants such as fentanyl, a potent synthetic opioid, and ketamine, an N-methyl-D-aspartate receptor antagonist, may enhance and prolong postoperative analgesia. Consequently, intraperitoneal instillation of local anesthetics with adjuvant agents represents a simple, safe, and effective method for improving postoperative pain control following LC.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

84

Fase

  • Fase 4

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

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

Ja

Beskrivelse

Inclusion Criteria:

  • Patients of age 20-50 years
  • Patients of either gender
  • Patients planned to undergo elective LC.
  • Patients have I-II of the American Society of Anaesthesiologists (ASA)

Exclusion Criteria:

  • Patient's refusal.
  • body mass index (BMI) ≥40 kg/m2.
  • History of hypersensitivity to the drugs being evaluated
  • Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.
  • chronic use of opioids and opioid addiction
  • Patients with acute cholecystitis or converted to open surgery.
  • Carcinoma of gall bladder
  • Pregnant female
  • Bleeding disorders

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: Fentanyl

Fentanyl used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose of 1 ug/kg is commonly added to the local anesthetic solution.

Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol.

Fentanyl used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose of 1 ug/kg is commonly added to the local anesthetic solution.

Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol.

Eksperimentel: ketamine

Ketamine used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose of 0.25 mg/kg is commonly added to the local anesthetic solution.

Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol.

Ketamine used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose of 0.25 mg/kg is commonly added to the local anesthetic solution.

Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time of first analgesic request.
Tidsramme: 24 hours
The primary outcome of the study is comparison of the post-operative analgesic effect regarding the time to first analgesic request of fentanyl versus Ketamine as adjuvants to bupivacaine in patients undergoing laparoscopic cholecystectomy
24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total analgesia consumption postoperatively.
Tidsramme: 24 hours
Total Nalphuine consumption in milligrams, in the first 24 hours postoperatively.
24 hours
Postoperative Numeric Rating Scale of pain
Tidsramme: 24 hours postoperatively.
Postoperative Numeric Rating Scale of pain.( in post-anaesthesia care unit, half hour, 2, 6, 12, 18, 24 hours postoperatively)
24 hours postoperatively.

Samarbejdspartnere og efterforskere

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Efterforskere

  • Ledende efterforsker: Tarek Mo Essa Tohamy, Assiut University

Publikationer og nyttige links

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Generelle publikationer

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. august 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2026

Sidst verificeret

1. juni 2026

Mere information

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