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Rectointercostal Plane Block (RICPB) for Laparoscopic Cholecystectomy (RICPB)

30. juni 2026 opdateret af: Ergün Mendes, Koç University

Rectointercostal Plane Block (RICPB) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

This prospective randomized controlled trial is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block (RICPB) in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized to receive unilateral right-sided RICPB at the end of surgery. Postoperative opioid consumption, Numeric Rating Scale (NRS) pain scores, and postoperative complications will be assessed to determine the effectiveness of RICPB in postoperative pain management.

Studieoversigt

Detaljeret beskrivelse

Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures. Although it is considered a minimally invasive technique, patients frequently experience moderate postoperative pain resulting from trocar insertion sites, surgical manipulation, and irritation of the abdominal wall and peritoneum. Effective postoperative pain management is essential to facilitate early mobilization, improve patient comfort, reduce opioid consumption, and enhance recovery.

The rectointercostal plane block (RICPB) is an ultrasound-guided fascial plane block that has recently emerged as a potential analgesic technique for upper abdominal surgery. By depositing local anesthetic between the rectus abdominis muscle and the costal cartilages/intercostal muscles, RICPB may provide analgesia to the anterior upper abdominal wall. However, evidence regarding its effectiveness in laparoscopic cholecystectomy remains limited.

This single-center, prospective, randomized controlled trial is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block in patients undergoing elective laparoscopic cholecystectomy. Eligible patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be enrolled after providing written informed consent. Participants will be randomly allocated in a 1:1 ratio to either the RICPB group or the control group.

Patients assigned to the RICPB group will receive an ultrasound-guided unilateral right-sided rectointercostal plane block with 30 mL of 0.25% bupivacaine at the end of surgery before emergence from anesthesia. Patients in the control group will receive conventional port-site local anesthetic infiltration according to institutional practice. All patients will undergo a standardized general anesthesia protocol and receive the same multimodal postoperative analgesic regimen.

Postoperative pain assessments will be performed using the Numeric Rating Scale (NRS). Opioid consumption, pain scores and postoperative complications, including postoperative nausea and vomiting (PONV), will be recorded during the first 24 postoperative hours.

The primary outcome of the study is cumulative opioid consumption during the first 24 postoperative hours. Secondary outcomes include postoperative NRS pain scores, rescue analgesic requirements, and the incidence of postoperative complications. The study aims to determine whether ultrasound-guided rectointercostal plane block provides superior postoperative analgesia compared with conventional port-site local anesthetic infiltration in patients undergoing laparoscopic cholecystectomy.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Studiesteder

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

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  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

Inclusion Criteria:

  • Age between 18 and 65 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective laparoscopic cholecystectomy
  • Body mass index (BMI) between 18 and 35 kg/m²
  • Ability to understand the study procedures and provide written informed consent

Exclusion Criteria:

  • Refusal to participate or inability to provide informed consent
  • Known allergy or hypersensitivity to local anesthetics, opioids, or study medications
  • Chronic opioid use or chronic pain syndrome
  • Coagulation disorders or ongoing anticoagulant therapy
  • Infection at the planned injection site
  • Pregnancy or breastfeeding
  • Cognitive impairment or inability to communicate pain scores
  • Severe hepatic, renal, cardiac, or respiratory disease judged by the investigator to interfere with study participation
  • Conversion from laparoscopic to open surgery
  • Previous upper abdominal surgery that may interfere with the block technique or pain assessment

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: RICPB Group
Participants will receive an ultrasound-guided unilateral right-sided rectointercostal plane block (RICPB) with 30 mL of 0.25% bupivacaine at the end of surgery before emergence from anesthesia.
Ultrasound-guided unilateral right-sided rectointercostal plane block (RICPB) will be performed at the end of surgery before emergence from anesthesia. A total of 30 mL of 0.25% bupivacaine will be injected into the rectointercostal plane under ultrasound guidance.
Andre navne:
  • RICPB
Aktiv komparator: Port-Site Infiltration Group
Participants will receive conventional port-site local anesthetic infiltration at the end of surgery according to the study protocol.
Conventional port-site local anesthetic infiltration will be performed at the end of surgery according to the study protocol to provide postoperative analgesia.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cumulative Postoperative Morphine Consumption
Tidsramme: Postoperative 24 hours
Total morphine consumption administered via patient-controlled analgesia during the first 24 hours after surgery will be recorded.
Postoperative 24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rescue Analgesic Requirement
Tidsramme: Postoperative 24 hours
The requirement for rescue analgesia during the first 24 postoperative hours will be recorded. Rescue analgesia will be administered according to the study protocol when the NRS pain score is 4 or higher.
Postoperative 24 hours
Postoperative Complications
Tidsramme: Postoperative 24 hours
The incidence of postoperative complications, including postoperative nausea and vomiting (PONV), pruritus, respiratory complications, and other adverse events occurring during the postoperative period, will be recorded.
Postoperative 24 hours
Postoperative Pain Scores
Tidsramme: Postoperative 1, 3, 6, 12, and 24 hours
Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10) at predefined postoperative time points. NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Postoperative 1, 3, 6, 12, and 24 hours

Samarbejdspartnere og efterforskere

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Sponsor

Publikationer og nyttige links

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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)

31. januar 2027

Studieafslutning (Anslået)

1. februar 2027

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

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Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Rectointercostal Plane Block

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