Two Bupivacaine Concentrations for Rectus Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedipol University

About this trial

Pain after laparoscopic cholecystectomy remains clinically relevant, and current recommendations favour multimodal, opioid-sparing analgesia including regional techniques. The rectus intercostal fascial plane block (RIFPB) is a recently described technique in which local anesthetic is injected into the plane between the rectus abdominis muscle and the 6th and 7th costal cartilages, targeting the anterior and lateral cutaneous branches of the sixth to ninth thoracic (T6-T9) thoracoabdominal nerves.

In the investigators' previous randomized controlled trial, bilateral RIFPB after laparoscopic cholecystectomy significantly reduced the need for rescue analgesia (17.9% versus 55.3%) and pain scores during the first 12 postoperative hours. That trial used 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total), a dose approaching the recommended upper limit, and whether lower doses provide comparable analgesia remains unknown. Because fascial plane blocks depend on local anesthetic spread, large volumes are preferred, increasing the total dose and the risk of local anesthetic systemic toxicity (LAST); lowering the concentration as volume increases has therefore been recommended. Equal-volume studies of transversus abdominis plane and erector spinae plane blocks suggest that lower concentrations provide comparable analgesia, but no study has compared concentrations for RIFPB.

This trial will compare, at a fixed volume of 30 mL per side (60 mL in total), bilateral RIFPB with 0.25% bupivacaine, bilateral RIFPB with 0.125% bupivacaine, and routine port-site infiltration without a block (control) in adults undergoing elective laparoscopic cholecystectomy under general anesthesia. Ninety patients will be randomly allocated in a 1:1:1 ratio.

The primary outcome is total rescue tramadol consumption during the first 24 postoperative hours. Secondary outcomes include numeric rating scale (NRS) pain scores at rest and on movement, the need for and time to first rescue analgesia, nausea, vomiting and pruritus, block-related complications and signs of LAST, patient satisfaction, and length of hospital stay.

The investigators hypothesize that RIFPB at either concentration will reduce analgesic consumption and pain scores compared with control, and that the lower concentration will provide comparable analgesia while halving the total bupivacaine dose (75 mg instead of 150 mg), thereby reducing the risk of LAST.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for elective laparoscopic cholecystectomy under general anesthesia

Aged between 18 and 65 years

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

Body weight above 60 kg

Disqualifiers

Known allergy or hypersensitivity to local anesthetics or opioids

Coagulopathy or ongoing anticoagulant therapy

Infection at the site of block injection

Alcohol or substance dependence, or chronic opioid use

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine 0.25% - rectus intercostal fascial plane block

    Drug

    Bilateral ultrasound-guided rectus intercostal fascial plane block (RIFPB) with a high-frequency linear probe (11-12 MHz) and an 80 mm block needle. The probe is placed 3-4 cm lateral and caudal to the epigastrium to visualize the rectus abdominis muscle and the 6th and 7th costal cartilages; after in-plane hydrodissection with 5 mL of saline, 30 mL of 0.25% bupivacaine is injected on each side (60 mL, 150 mg in total). Aspiration is performed before injection and the drug is given in fractionated doses.

  • Bupivacaine 0.125% - rectus intercostal fascial plane block

    Drug

    Bilateral ultrasound-guided rectus intercostal fascial plane block (RIFPB) performed with the identical technique and the identical volume as in Group Y, using 30 mL of 0.125% bupivacaine per side (60 mL, 75 mg in total). The solution is prepared by diluting 15 mL of 0.5% bupivacaine with 45 mL of 0.9% saline.

  • Bupivacaine 0.25% - port-site infiltration

    Drug

    Routine institutional practice: infiltration of the laparoscopic port sites by the surgical team with 30 mL of 0.25% bupivacaine (75 mg). No fascial plane block is performed.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group Y - Recto-intercostal fascial plane block with 0.25% bupivacaineExperimental treatment 1 intervention
Group B: Group D - Recto-intercostal fascial plane block with 0.125% bupivacaineExperimental treatment 1 intervention
Group C: Group K - Control (port-site infiltration)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total rescue tramadol consumption during the first 24 postoperative hours

Cumulative dose of intravenous tramadol administered as rescue analgesia (milligrams) during the first 24 hours after extubation. Rescue tramadol 0.5-1 mg/kg intravenously is administered whenever the numeric rating scale (NRS) score is 4 or higher.

Time frame
0 to 24 hours after extubation

Secondary outcomes

1

Pain intensity at rest measured with the Numeric Rating Scale (NRS)

Pain at rest rated by the participant on an 11-point numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain.

Time frame
1, 3, 6, 12, 18 and 24 hours after extubation
2

Pain intensity on movement measured with the Numeric Rating Scale (NRS)

Pain during movement (coughing or sitting up) rated by the participant on an 11-point numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain.

Time frame
1, 3, 6, 12, 18 and 24 hours after extubation
3

Proportion of participants requiring rescue analgesia

Number and percentage of participants in each group who receive at least one dose of rescue intravenous tramadol during the first 24 postoperative hours.

Time frame
0 to 24 hours after extubation
4

Time to first rescue analgesic request

Time in minutes from extubation to administration of the first dose of rescue intravenous tramadol. Participants who require no rescue analgesia are censored at 24 hours.

Time frame
0 to 24 hours after extubation

Other outcomes

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