- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07670052
Intraperitoneal Ketamine Versus Fentanyl as Adjuvants to Bupivacaine in Laparoscopic Cholecystectomy
Intraperitoneal Instillation of Ketamine Versus Fentanyl as Adjuvants to Bupivacaine for Postoperative Pain Control in Laparoscopic Cholecystectomy _a Double-blinded Randomized Trial.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Tarek Mo Essa Tohamy
- Telefonnummer: +201027342291
- E-mail: tarekessa970@gmail.com
Undersøgelse Kontakt Backup
- Navn: Eman Ah Ismail, MD
- Telefonnummer: +20 1060223750
- E-mail: emanismail@aun.edu.eg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
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
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
Sponsor
Efterforskere
- Ledende efterforsker: Tarek Mo Essa Tohamy, Assiut University
Publikationer og nyttige links
Generelle publikationer
- Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg. 2006 Sep;103(3):682-8. doi: 10.1213/01.ane.0000226268.06279.5a.
- Glick JL, Christensen T, Park JN, McKenzie M, Green TC, Sherman SG. Stakeholder perspectives on implementing fentanyl drug checking: Results from a multi-site study. Drug Alcohol Depend. 2019 Jan 1;194:527-532. doi: 10.1016/j.drugalcdep.2018.10.017. Epub 2018 Nov 13.
- Laisalmi M, Koivusalo AM, Valta P, Tikkanen I, Lindgren L. Clonidine provides opioid-sparing effect, stable hemodynamics, and renal integrity during laparoscopic cholecystectomy. Surg Endosc. 2001 Nov;15(11):1331-5. doi: 10.1007/s004640090126. Epub 2001 Aug 16.
- Khodorova A, Navarro B, Jouaville LS, Murphy JE, Rice FL, Mazurkiewicz JE, Long-Woodward D, Stoffel M, Strichartz GR, Yukhananov R, Davar G. Endothelin-B receptor activation triggers an endogenous analgesic cascade at sites of peripheral injury. Nat Med. 2003 Aug;9(8):1055-61. doi: 10.1038/nm885. Epub 2003 Jun 29.
- Kuhry E, Jeekel J, Bonjer HJ. Effect of laparoscopy on the immune system. Semin Laparosc Surg. 2004 Mar;11(1):37-44. doi: 10.1177/107155170401100107.
- Mannam R, Sankara Narayanan R, Bansal A, Yanamaladoddi VR, Sarvepalli SS, Vemula SL, Aramadaka S. Laparoscopic Cholecystectomy Versus Open Cholecystectomy in Acute Cholecystitis: A Literature Review. Cureus. 2023 Sep 21;15(9):e45704. doi: 10.7759/cureus.45704. eCollection 2023 Sep.
- Kahokehr A, Sammour T, Soop M, Hill AG. Intraperitoneal use of local anesthetic in laparoscopic cholecystectomy: systematic review and metaanalysis of randomized controlled trials. J Hepatobiliary Pancreat Sci. 2010 Sep;17(5):637-56. doi: 10.1007/s00534-010-0271-7.
- E. E. F. Mohamed, K. M. Hassan, W. A. Aboelwafa, and I. M. Ahmed, "Analgesia for Postoperative Pain in Laparoscopic Surgery: Review Article," Egypt. J. Hosp. Med., vol. 87, no. 1, 2022, doi: 10.21608/ejhm.2022.229353.
- Narchi P, Benhamou D, Fernandez H. Intraperitoneal local anaesthetic for shoulder pain after day-case laparoscopy. Lancet. 1991 Dec 21-28;338(8782-8783):1569-70. doi: 10.1016/0140-6736(91)92384-e.
- Hong E, Jeong DH, Kang HY, Choi JH, Park SW. The effect of preemptive intravenous ketamine on postoperative pain in patients undergoing arthroscopic rotator cuff repair with intra-articular ropivacaine injection Anesth Pain Med. 2003;11:71-75
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Smerte
- Neurologiske manifestationer
- Postoperative komplikationer
- Patologiske processer
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Smerter, postoperativ
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Kulbrinter
- Cyclohexanes
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Piperidiner
- Ketamin
- Fentanyl
Andre undersøgelses-id-numre
- 04-2026-201752
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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