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Clinical Trials/NCT07321639
NCT07321639
Not yet recruiting
Not Applicable

Comparison of the Effectiveness of Ultrasound-Guided Recto-Intercostal Fascial Plane Block and Transversus Abdominis Plane Block in Postoperative Analgesia Management of Patients Undergoing Laparoscopic Cholecystectomy

Istanbul Medipol University Hospital1 site in 1 country90 target enrollmentStarted: January 15, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Istanbul Medipol University Hospital
Enrollment
90
Locations
1
Primary Endpoint
Opioid consumption

Overview

Brief Summary

Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described abdominal wall block performed by injecting local anesthetic between the rectus abdominis muscle and the costal cartilage of the 7th rib. Due to the cranial attachment of the rectus muscle, this technique provides effective analgesia to the sternal, epigastric, and upper-mid abdominal regions, corresponding to the T6-T10/11 dermatomal levels. RIFPB may be used as an adjunct technique for thoracic procedures or as a standalone block for abdominal surgery.

Ultrasound-guided transversus abdominis plane block (TAPB) is performed by injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles. TAPB provides sensory blockade of the anterolateral abdominal wall at the T6-L1 dermatomal levels and is widely used for postoperative analgesia following abdominal surgeries, including laparoscopic cholecystectomy.

This study aims to compare the effectiveness of US-guided RIFPB and TAPB on postoperative pain control after laparoscopic cholecystectomy.

Detailed Description

Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures. Postoperative pain after laparoscopic cholecystectomy is multifactorial and may result from trocar site incisions, visceral manipulation, peritoneal irritation, and diaphragmatic stimulation due to pneumoperitoneum. Various analgesic strategies, including systemic opioids, non-opioid analgesics, local anesthetic infiltration, and regional anesthesia techniques, are used to manage postoperative pain in these patients.

Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described regional anesthesia technique that provides analgesia to the sternal, epigastric, and upper-mid abdominal regions by targeting the fascial plane between the rectus abdominis muscle and the costal cartilage. RIFPB provides sensory blockade at the T6-T10/11 dermatomal levels and has been reported to be effective for postoperative analgesia in thoracic and upper abdominal procedures. Due to its anatomical spread and mechanism of action, RIFPB may offer effective analgesia following laparoscopic cholecystectomy.

Ultrasound-guided transversus abdominis plane block (TAPB) is a well-established regional anesthesia technique performed by injecting local anesthetic between the internal oblique and transversus abdominis muscles. TAPB provides analgesia to the anterolateral abdominal wall at the T6-L1 dermatomal levels and is commonly used for postoperative pain control after various abdominal surgeries, including laparoscopic cholecystectomy.

In this study, the investigators aim to compare the effectiveness of US-guided RIFPB and TAPB for postoperative pain management after laparoscopic cholecystectomy and to compare both techniques with a control group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Outcomes assessor and participants will be blinded to the study

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ASA physical status I-II
  • Scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria

  • Known allergy to local anesthetics or opioid medications
  • Infection at the planned block site
  • History of alcohol or drug dependence
  • Use of anticoagulant therapy
  • Refusal to participate in the study

Arms & Interventions

Recto-intercostal fascial plane block

Active Comparator

RIFP block will be performed, and standard postoperative pain management protocols will be applied.

Intervention: Recto-Intercostal Fascial Plane Block (Procedure)

Recto-intercostal fascial plane block

Active Comparator

RIFP block will be performed, and standard postoperative pain management protocols will be applied.

Intervention: Post-operative Pain Management (Other)

Transversus abdominis plane block

Active Comparator

TAP block will be performed, and standard postoperative pain management protocols will be applied.

Intervention: Transversus- Abdominis Plane Block (Procedure)

Transversus abdominis plane block

Active Comparator

TAP block will be performed, and standard postoperative pain management protocols will be applied.

Intervention: Post-operative Pain Management (Other)

Control group

Active Comparator

Standard postoperative pain management protocols will be applied. No plane block will be applied.

Intervention: Post-operative Pain Management (Other)

Outcomes

Primary Outcomes

Opioid consumption

Time Frame: During the first 24 hours postoperatively

Total postoperative opioid consumption will be recorded for each patient during the first 24 hours after surgery. Opioid use will be quantified based on the total dose of rescue opioid analgesics administered and compared between study groups to assess differences in postoperative opioid requirements.

Secondary Outcomes

  • Postoperative pain scores(Postoperative hours 1, 3, 6, 12, 18, and 24.)
  • Adverse events(During the first 24 hours postoperatively)
  • Postoperative Rescue Analgesic Consumption:(During the first 24 hours postoperatively)

Investigators

Sponsor
Istanbul Medipol University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ayse Ince

Assistant Professor

Istanbul Medipol University Hospital

Study Sites (1)

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