An interventional study of Bupivacaine 0.25% - recto-intercostal fascial plane block and Bupivacaine 0.125% - recto-intercostal fascial plane block in Postoperative Pain, Acute Pain and Cholelithiasis, sponsored by Medipol University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Medipol University · Not applicable, Interventional, and Treatment
Pain after laparoscopic cholecystectomy remains clinically relevant, and current recommendations favour multimodal, opioid-sparing analgesia including regional techniques. The recto-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 25 mL per side (50 mL in total), bilateral RIFPB with 0.25% bupivacaine (125 mg), bilateral RIFPB with 0.125% bupivacaine (62.5 mg), and routine port-site infiltration with 25 mL of 0.25% bupivacaine 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 (coughing), 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 rescue tramadol consumption and pain scores compared with control, and that the lower concentration will halve the total bupivacaine dose (62.5 mg instead of 125 mg), thereby reducing the risk of LAST.
Design. This is a prospective, randomized, double-blind (participant and outcomes assessor), controlled, three-arm, parallel-group, single-centre trial to be conducted at Istanbul Medipol University Mega Hospital Complex. The trial will start only after approval by the Istanbul Medipol University Clinical Research Ethics Committee and authorization by the Turkish Medicines and Medical Devices Agency (TİTCK), and will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Bupivacaine, licensed in Turkey, is used within its approved indication. Written informed consent will be obtained from all participants before any study procedure.
Randomization and blinding. Before transfer to the operating room, patients will be allocated in a 1:1:1 ratio to one of three groups using a balanced sequence generated with the Research Randomizer program (www.randomizer.org). The allocation list will be kept by an anesthesiologist not otherwise involved in the conduct or assessment of the trial, who will prepare the study solutions under sterile conditions immediately before use (Group Y: 25 mL of 0.5% bupivacaine + 25 mL of 0.9% saline; Group D: 12.5 mL of 0.5% bupivacaine + 37.5 mL of 0.9% saline) and supply them in identical, indistinguishable 25 mL syringes for each side, labelled only with the randomization number. As both solutions are clear and colourless, the anesthesiologist performing the block is also blinded to the concentration. All procedures are performed under general anesthesia, so participants are unaware of their allocation. All postoperative assessments will be performed by an anesthesiologist blinded to group allocation who takes no part in the intervention, and statistical analysis will be performed on a dataset with masked group codes. If knowledge of the allocation is required for patient safety (e.g., suspected local anesthetic systemic toxicity), it can be obtained immediately from the anesthesiologist who prepared the solution.
Groups. Group Y receives bilateral recto-intercostal fascial plane block (RIFPB) with 25 mL of 0.25% bupivacaine per side (50 mL, 125 mg in total). Group D receives bilateral RIFPB with 25 mL of 0.125% bupivacaine per side (50 mL, 62.5 mg in total). Group K (control) receives no block and is managed with the institution's routine analgesic protocol, including port-site infiltration with 25 mL of 0.25% bupivacaine (62.5 mg) performed by the surgical team. The injected volume is identical in both block groups; only the concentration, and therefore the administered dose, differs. The investigators' previous trial used 30 mL per side for the block and 30 mL for port-site infiltration; in this trial the volume has been set at 25 mL to reduce the total local anesthetic dose. To allow the isolated effect of the block to be assessed, port-site infiltration is not performed in the block groups. The total single dose of bupivacaine (at most 125 mg) will not exceed the maximum single adult dose stated in the product information (150 mg) in any patient, and patients weighing 60 kg or less are not included.
Anesthesia and surgery. Standard monitoring (electrocardiography, non-invasive blood pressure and pulse oximetry) will be applied. After premedication with 2 mg of intravenous midazolam, general anesthesia will be induced with propofol (2-2.5 mg/kg), fentanyl (1-1.5 mcg/kg) and rocuronium (0.6 mg/kg), and maintained with sevoflurane in an oxygen-air mixture and a remifentanil infusion (0.05-2 mcg/kg/min). All patients will receive 4 mg of intravenous ondansetron for nausea prophylaxis, and 400 mg of intravenous ibuprofen and 100 mg of intravenous tramadol approximately 20 minutes before skin closure. Surgery will be performed by the same team using the conventional four-port technique.
Block technique. The block will be performed bilaterally at the end of surgery, before extubation, with the patient supine and under general anesthesia. Using a high-frequency linear ultrasound probe (11-12 MHz) and a 22-gauge, 80 mm block needle, the probe will be placed in a sagittal orientation 3-4 cm lateral and caudal to the epigastrium to visualize the rectus abdominis muscle and the 6th and 7th costal cartilages. With an in-plane technique in a caudal-to-cranial direction, hydrodissection with 5 mL of saline will be performed, 25 mL of the study solution will be injected on each side, and spread will be confirmed with ultrasound. Aspiration will be performed before injection and after every 5 mL, the drug will be given in fractionated doses, patients will be continuously monitored, and 20% lipid emulsion will be immediately available in the operating room.
Postoperative analgesia and assessment. All patients will receive 400 mg of intravenous ibuprofen every 8 hours. Pain will be assessed by the blinded assessor with the numeric rating scale (NRS; 0 = no pain, 10 = worst imaginable pain) at rest and on movement (coughing) at 1, 3, 6, 12, 18 and 24 hours postoperatively. Rescue analgesia with 0.5-1 mg/kg of intravenous tramadol will be given whenever the NRS score is 4 or higher, up to a maximum daily tramadol dose of 400 mg. The standard 100 mg of tramadol given to all patients at the end of surgery is not included in the primary outcome. Patients with inadequate analgesia despite rescue tramadol will receive additional analgesic treatment at the discretion of the responsible physician, and this will be recorded. Nausea and vomiting will be treated according to routine clinical practice.
Withdrawal. Patients will be withdrawn if they are converted to open surgery after randomization, withdraw consent, or require postoperative mechanical ventilation or intensive care because of a serious surgical or anesthetic complication; if the study solution or intervention cannot be administered according to the protocol; or if the responsible investigator considers withdrawal necessary for patient safety. Withdrawn patients will continue to receive standard care.
Sample size. The sample size was calculated with G*Power 3.1, assuming that the primary outcome would be compared among the three groups with one-way analysis of variance. Considering the marked difference in rescue analgesic requirement between RIFPB and control in the investigators' previous trial (17.9% versus 55.3%), a medium-to-large effect size (f = 0.35), an alpha of 0.05 and 80% power yielded 84 patients (28 per group). Allowing for approximately 7% data loss, 30 patients per group (90 in total) will be enrolled.
Statistical analysis. Data will be analysed with SPSS 25.0 (IBM Corp., Armonk, NY, USA). Normality will be assessed with the Shapiro-Wilk test; normally distributed variables will be presented as mean ± standard deviation and non-normally distributed variables as median (interquartile range). Normally distributed variables will be compared among the three groups using one-way analysis of variance (ANOVA) with post hoc Bonferroni tests, and non-normally distributed variables, including 24-hour rescue tramadol consumption, using the Kruskal-Wallis test followed by Bonferroni-corrected Mann-Whitney U tests. Categorical variables will be presented as number (%) and compared with the chi-square test or, when any expected cell count is below 5, the Fisher-Freeman-Halton exact test. NRS scores will be compared among groups at each time point with the Kruskal-Wallis test, and time to first rescue analgesia will be analysed with the Kaplan-Meier method and the log-rank test. Between-group differences in the primary outcome will be reported with 95% confidence intervals. Bonferroni correction will be applied to pairwise comparisons; otherwise a p value below 0.05 will be considered statistically significant. Analyses will include randomized patients who complete the 24-hour follow-up; withdrawn patients will be reported with reasons in the CONSORT flow diagram.
Ethical considerations. Patients in the control group will not be deprived of analgesic treatment; they will receive the institution's routine port-site infiltration and standard multimodal analgesia protocol, and rescue analgesia whenever the NRS score is 4 or higher. All drugs used are licensed in Turkey and used in routine clinical practice. Patient data will be stored in coded form. The study has no external funding and the investigators declare no conflict of interest.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 90 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.
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The criteria were revised on the registry on Oct 29, 2026. See what changed
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilateral ultrasound-guided recto-intercostal fascial plane block performed under general anesthesia at the end of surgery, before extubation, with 25 mL of 0.25% bupivacaine per side (50 mL, 125 mg in total). Port-site infiltration is not performed. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg/kg whenever the numeric rating scale (NRS) score is 4 or higher.
Drug: Bupivacaine 0.25% - recto-intercostal fascial plane block
Bilateral ultrasound-guided recto-intercostal fascial plane block performed under general anesthesia at the end of surgery, before extubation, with 25 mL of 0.125% bupivacaine per side (50 mL, 62.5 mg in total). The injected volume is identical to that of Group Y; only the concentration, and therefore the administered dose, differs. Port-site infiltration is not performed. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg/kg whenever the numeric rating scale (NRS) score is 4 or higher.
Drug: Bupivacaine 0.125% - recto-intercostal fascial plane block
No fascial plane block is performed. Patients are managed with the institution's routine analgesic protocol, including port-site infiltration with 25 mL of 0.25% bupivacaine (62.5 mg) performed by the surgical team. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg/kg whenever the numeric rating scale (NRS) score is 4 or higher.
Drug: Bupivacaine 0.25% - port-site infiltration
Bilateral ultrasound-guided recto-intercostal fascial plane block (RIFPB) with a high-frequency linear probe (11-12 MHz) and a 22-gauge, 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, 25 mL of 0.25% bupivacaine is injected on each side (50 mL, 125 mg in total). The solution is prepared by diluting 25 mL of 0.5% bupivacaine with 25 mL of 0.9% saline. Aspiration is performed before injection and after every 5 mL, and the drug is given in fractionated doses.
Bilateral ultrasound-guided recto-intercostal fascial plane block (RIFPB) performed with the identical technique and the identical volume as in Group Y, using 25 mL of 0.125% bupivacaine per side (50 mL, 62.5 mg in total). The solution is prepared by diluting 12.5 mL of 0.5% bupivacaine with 37.5 mL of 0.9% saline.
Routine institutional practice: infiltration of the laparoscopic port sites by the surgical team with 25 mL of 0.25% bupivacaine (62.5 mg). No fascial plane block is performed.
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. The standard 100 mg of tramadol given to all patients before the end of surgery is not included.
Time frame: 0 to 24 hours after extubation
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
Pain intensity on movement measured with the Numeric Rating Scale (NRS)
Pain on movement (coughing) 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
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
Time to first rescue analgesic request
Time in hours 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
Incidence of postoperative nausea and vomiting and antiemetic requirement
Number and percentage of participants with at least one episode of nausea, with at least one episode of vomiting, and requiring antiemetic treatment during the first 24 postoperative hours.
Time frame: 0 to 24 hours after extubation
Incidence of pruritus
Number and percentage of participants reporting pruritus during the first 24 postoperative hours.
Time frame: 0 to 24 hours after extubation
Incidence of block-related complications and signs of local anesthetic systemic toxicity (LAST)
Number and percentage of participants with block-related complications (haematoma, intraperitoneal or vascular puncture, pneumothorax, infection at the injection site) or clinical signs of local anesthetic systemic toxicity (perioral numbness, tinnitus, altered mental status, seizure, arrhythmia, cardiovascular collapse).
Time frame: From performance of the block until 24 hours after extubation
Patient satisfaction with postoperative analgesia
Satisfaction with postoperative pain management rated by the participant on a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores indicate greater satisfaction.
Time frame: At 24 hours after extubation
Length of hospital stay
Time in days from the end of surgery until hospital discharge.
Time frame: From end of surgery until hospital discharge, assessed up to 7 days
Plan to share: Yes — De-identified individual participant data underlying the published results will be made available to qualified researchers whose proposed use of the data has been approved by the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 6 months and ending 3 years after publication of the main results
Access criteria: Requests should be sent by e-mail to the principal investigator and must include a methodologically sound research proposal. Data will be shared after approval of the proposal and completion of a data access agreement.
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Studies of the drug tested here: Bupivacaine