Recto-Intercostal Fascial Plane and External Oblique Intercostal Blocks for Pain in Laparoscopic Cholecystectomyin Laparoscopic Cholecystectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAnkara Etlik City Hospital

About this trial

Laparoscopic cholecystectomy is a common surgical procedure that can cause significant postoperative pain, particularly originating from trocar insertion sites. Regional anesthesia techniques are frequently used as part of multimodal analgesia to improve patient comfort.

This randomized controlled trial aims to evaluate the efficacy of adding a recto-intercostal fascial plane block (RIFPB) to an external oblique intercostal plane block (EOIPB). Patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned to receive either an EOIPB alone or a combination of EOIPB and RIFPB. The primary objective is to determine if the combined block approach provides superior postoperative analgesia, evaluated by compared to the EOIPB alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18 and 75 years

American Society of Anesthesiologists (ASA) physical status I, II, or III

Patients scheduled for elective laparoscopic cholecystectomy

Disqualifiers

Known allergy to local anesthetics

Infection at the procedure/injection site

Severe coagulopathy or use of anticoagulants

Chronic opioid consumption or history of neuropathic pain

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group EOIPB (External Oblique Intercostal Plane Block)

    Procedure/Surgery

    Patients will undergo bilateral EOIPB procedure using 20 ml of 0.20% bupivacaine on each side under ultrasound guidance.

  • Group EOIPB + RIFPB (Combined Blocks)

    Procedure/Surgery

    Patients will undergo bilateral EOIPB and RIFPB procedures under ultrasound guidance using 20 ml of 0.20% bupivacaine for the EOIPB block and 15 ml of 0.20% bupivacaine for the RIFPB on each side.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Group EOIPB (External Oblique Intercostal Plane Block)Active comparator 1 intervention
Group B: Group EOIPB + RIFPB (Combined Blocks)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain Intensity

Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest. Pain assessment at rest will be made at 4 hours after surgery.

Time frame
4 hours after surgery

Secondary outcomes

1

Postoperative Pain Intensity

Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest. Pain assessment at rest will be made at 1, 8, 12, and 24 hours after surgery.

Time frame
Up to 24 hours
2

Postoperative Pain Intensity

ain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) while coughing. Pain assessment will be made at 1, 4, 8, 12, and 24 hours after surgery.

Time frame
Up to 24 hours
3

Total Postoperative Opioid Consumption

The total amount of opioid consumed by the patient will be recorded.

Time frame
Up to 24 hours
4

Severity of Postoperative Nausea and Vomiting (PONV)

The severity of postoperative nausea will be assessed using an 11-point numerical rating scale (NRS), ranging from 0 to 10, where 0 indicates no nausea and 10 indicates the worst possible nausea. Vomiting will be recorded as the number of vomiting episodes. Nausea severity will be assessed at 1, 4, 8, 12, and 24 hours after surgery. Higher NRS scores indicate greater nausea severity.

Time frame
Up to 24 hours

Other outcomes

Sponsors and contacts

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