Regional Analgesia Techniques for Laparoscopic Cholecystectomy
NCT ID: NCT07241949
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
147 participants
INTERVENTIONAL
2025-12-01
2026-06-05
Brief Summary
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Detailed Description
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Although laparoscopic cholecystectomy is a minimally invasive procedure, postoperative pain remains a significant clinical problem, particularly during the first 24 hours after surgery. Effective multimodal analgesia is essential to improve patient comfort, facilitate early mobilization, and reduce opioid-related side effects. Regional anesthesia techniques, such as PVB and EOI block, target both somatic and visceral components of pain and may offer superior postoperative analgesia compared with systemic opioid administration alone.
After obtaining informed consent, eligible patients (aged 18-65 years, ASA I-III) scheduled for elective LC will be randomly assigned to one of three groups using the sealed envelope method:
Group P (Paravertebral Block): After induction of general anesthesia, bilateral paravertebral blocks will be performed at thoracic levels with 0.25% bupivacaine (20 mL per side; total 40 mL).
Group E (External Oblique Intercostal Block): After induction, bilateral EOI blocks will be performed using 0.25% bupivacaine (20 mL per side; total 40 mL) injected into the fascial plane between the external oblique and intercostal muscles under ultrasound guidance.
Group C (Control): Patients will receive standard general anesthesia followed by IV PCA with tramadol (maximum dose 400 mg/24h) and IV paracetamol 1 g every 8 hours.
All patients will receive standard intraoperative monitoring and anesthesia management. Postoperative analgesia will be evaluated using an 11-point Numerical Rating Scale (NRS, 0-10) both at rest and during movement at 20 minutes, 6 hpurs, 12 hours, and 24 hours after surgery. If the NRS score is ≥4 in the postoperative care unit, IV morphine (0.05 mg/kg), If the NRS score is ≥7 Meperidine 0.3 mg/kg will be administered as rescue analgesia.
The primary outcome is total tramadol consumption within the first 24 postoperative hours.
Secondary outcomes include pain scores at predefined time points, requirement for rescue analgesics, incidence of postoperative nausea and vomiting (PONV), time to mobilization, and length of hospital stay.
Patients will be followed for 24 hours postoperatively. The anesthesia team performing the blocks will not participate in data collection. Pain assessments will be conducted by an investigator blinded to group allocation to minimize bias.
This study will provide comparative data on two ultrasound-guided regional anesthesia techniques and systemic opioid-based analgesia for LC, aiming to identify the method that ensures optimal postoperative pain control with the least opioid requirement and side effects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Paravertebral Block Group
Participants in this arm will receive bilateral paravertebral block after induction of general anesthesia. Under ultrasound guidance, 0.25% bupivacaine (20 mL per side; total 40 mL) will be administered to provide postoperative analgesia following laparoscopic cholecystectomy. Patients will also receive standard intravenous paracetamol postoperatively.
Paravertebral Block (PVB)
Ultrasound-guided bilateral thoracic paravertebral block performed after induction of general anesthesia using 0.25% bupivacaine, 20 mL per side (total 40 mL).
External Oblique Intercostal Block Group
Participants in this arm will receive bilateral external oblique intercostal (EOI) block after induction of general anesthesia. Under ultrasound guidance, 0.25% bupivacaine (20 mL per side; total 40 mL) will be injected into the fascial plane between the external oblique and intercostal muscles. Standard intravenous paracetamol will be administered postoperatively.
External Oblique Intercostal Block (EOI Block)
Ultrasound-guided bilateral external oblique intercostal block performed after induction of general anesthesia with 0.25% bupivacaine, 20 mL per side (total 40 mL), injected between the external oblique and intercostal muscles.
Control Group - IV PCA Tramadol
Participants in this arm will receive intravenous patient-controlled analgesia (PCA) with tramadol for postoperative pain management. The PCA pump will be set to a maximum dose of 400 mg tramadol in 24 hours. Standard intravenous paracetamol (1 g every 8 hours) will also be administered. No regional anesthesia block will be performed in this group.
Tramadol IV Patient-Controlled Analgesia (PCA)
Intravenous patient-controlled analgesia (PCA) programmed to deliver tramadol with a maximum dose of 400 mg in 24 hours. Standard analgesia protocol includes IV paracetamol 1 g every 8 hours.
Interventions
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Paravertebral Block (PVB)
Ultrasound-guided bilateral thoracic paravertebral block performed after induction of general anesthesia using 0.25% bupivacaine, 20 mL per side (total 40 mL).
External Oblique Intercostal Block (EOI Block)
Ultrasound-guided bilateral external oblique intercostal block performed after induction of general anesthesia with 0.25% bupivacaine, 20 mL per side (total 40 mL), injected between the external oblique and intercostal muscles.
Tramadol IV Patient-Controlled Analgesia (PCA)
Intravenous patient-controlled analgesia (PCA) programmed to deliver tramadol with a maximum dose of 400 mg in 24 hours. Standard analgesia protocol includes IV paracetamol 1 g every 8 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for elective laparoscopic cholecystectomy under general anesthesia
* ASA physical status I-III
* Able to understand the study procedure and provide informed consent
Exclusion Criteria
Allergy or contraindication to local anesthetics, tramadol, or study medications
Coagulopathy or current anticoagulant therapy
Local infection at the planned block injection site
Severe hepatic or renal impairment
Chronic opioid use or opioid dependence
Neurological or psychiatric disorders affecting pain perception or communication
Pregnancy or breastfeeding
Body mass index (BMI) \> 35 kg/m²
Conversion to open cholecystectomy during surgery
18 Years
65 Years
ALL
No
Sponsors
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Cukurova University
OTHER
Responsible Party
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Nurefsan Sadikoglu
Attending Specialist
Principal Investigators
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Nurefsan Sadikoglu, MD
Role: PRINCIPAL_INVESTIGATOR
Cukurova University Hospital
Locations
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Cukurova University Faculty of Medicine
Adana, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
Erskine RN, White L. "A review of the external oblique intercostal plane block - a novel approach to analgesia for upper abdominal surgery". J Clin Anesth. 2022 Nov;82:110953. doi: 10.1016/j.jclinane.2022.110953. Epub 2022 Aug 19. No abstract available.
Hamilton DL, Manickam BP, Wilson MAJ, Abdel Meguid E. External oblique fascial plane block. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100256. doi: 10.1136/rapm-2018-100256. Online ahead of print. No abstract available.
Hamilton DL, Manickam BP. Is a Thoracic Fascial Plane Block the Answer to Upper Abdominal Wall Analgesia? Reg Anesth Pain Med. 2018 Nov;43(8):891-892. doi: 10.1097/AAP.0000000000000838. No abstract available.
Kus A, Gurkan Y, Arslan ZI, Akgul AG, Aksu C, Toker K, Solak M. [Our ultrasound-guided paravertebral block experiences in thoracic surgery]. Agri. 2015;27(3):139-42. doi: 10.5505/agri.2015.59885. Turkish.
Barazanchi AWH, MacFater WS, Rahiri JL, Tutone S, Hill AG, Joshi GP; PROSPECT collaboration. Evidence-based management of pain after laparoscopic cholecystectomy: a PROSPECT review update. Br J Anaesth. 2018 Oct;121(4):787-803. doi: 10.1016/j.bja.2018.06.023. Epub 2018 Aug 7.
O'Donovan B, Martin B. The Novel Use of an External Oblique Nerve Catheter After Open Cholecystectomy. Cureus. 2021 Feb 26;13(2):e13580. doi: 10.7759/cureus.13580.
Alper I, Ulukaya S, Yuksel G, Uyar M, Balcioglu T. Laparoscopic cholecystectomy pain: effects of the combination of incisional and intraperitoneal levobupivacaine before or after surgery. Agri. 2014;26(3):107-12. doi: 10.5505/agri.2014.42650.
Shrestha BB, Lakhe G, Ghimire P. Postoperative Pain after Laparoscopic Cholecystectomy in a Tertiary Care Center: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2024 Jul 31;62(276):502-506. doi: 10.31729/jnma.8719.
De Cassai A, Sella N, Geraldini F, Tulgar S, Ahiskalioglu A, Dost B, Manfrin S, Karapinar YE, Paganini G, Beldagli M, Luoni V, Ordulu BBK, Boscolo A, Navalesi P. Single-shot regional anesthesia for laparoscopic cholecystectomies: a systematic review and network meta-analysis. Korean J Anesthesiol. 2023 Feb;76(1):34-46. doi: 10.4097/kja.22366. Epub 2022 Nov 8.
Other Identifiers
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Pending-EC-2025-NSadikoglu
Identifier Type: -
Identifier Source: org_study_id
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