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This single-center, prospective, randomized controlled trial aims to compare the effects of paravertebral block (PVB), external oblique intercostal (EOI) block, and intravenous patient-controlled analgesia (PCA) with tramadol on postoperative pain and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint is total tramadol consumption within 24 hours postoperatively. Secondary outcomes include pain scores, additional analgesic use, incidence of nausea/vomiting, mobilization time, and length of hospital stay.
This single center, prospective, randomised controlled clinical trial is designed to evaluate analgesic efficacy and opioid sparing effect of ultrasound guided paravertebral block (PVB) and external oblique intercostal (EOI) block versus systemic opioid based analgesia in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Pain after laparoscopic cholecystectomy is often moderate to severe during the first 24 hours , and has somatic and visceral components . Regional approaches that target thoracoabdominal dermatomes and visceral afferents may provide superior analgesia, allow for earlier mobilisation, and reduce opioid-related adverse effects compared with intravenous opioid regimens alone. PVB provides unilateral segmental blockade at thoracic paravertebral level, while the EOI block deposits local anaesthetic in the fascial plane between the external oblique and intercostal muscles, with spread to relevant thoracoabdominal nerves.
In a parallel-group design, participants will be randomly allocated to bilateral thoracic PVB, bilateral EOI block or no truncal block with standard systemic analgesia. All regional blocks will be performed under ultrasound guidance after induction of general anaesthesia. Standardised volumes and concentrations of long-acting local anaesthetic will be used according to institutional practice. The control group will receive patient-controlled intravenous opioid analgesia as part of a multimodal approach.
Standardisation of intraoperative monitoring and technique of general anaesthesia according to departmental protocols will be done for perioperative anaesthetic management. Postoperative pain intensity will be assessed by an 11-point Numerical Rating Scale at specified time points during the first 24 hours. Rescue analgesia will be administered according to a predefined algorithm. The trial's purpose is to compare postoperative opioid use between groups and to investigate differences in pain trajectories and opioid-related adverse events in routine clinical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral Block Group | Active Comparator | 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. |
|
| External Oblique Intercostal Block Group | Active Comparator | 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. |
|
| Control Group - IV PCA Tramadol | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paravertebral Block (PVB) | Procedure | Ultrasound-guided bilateral thoracic paravertebral block performed after induction of general anesthesia using 0.25% bupivacaine, 20 mL per side (total 40 mL). |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour postoperative tramadol consumption | Total amount of intravenous tramadol administered via PCA within the first 24 hours after surgery. | Within the first 24 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain scores at rest | Postoperative pain intensity at rest will be assessed using the 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate more severe pain. | 1, 6, 12, and 24 hours postoperatively |
| Incidence of postoperative nausea and vomiting |
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Inclusion Criteria:
Exclusion Criteria:
Patient refusal or inability to provide informed consent
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nurefsan Sadikoglu, MD | Contact | +(90) 538 926 2414 | nurefsansadikoglu@gmail.com | |
| Zehra Hatipoglu, MD | Contact | +(90) 532 447 1670 | hatipogluzehra@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nurefsan Sadikoglu, MD | Cukurova University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cukurova University Faculty of Medicine | Recruiting | Adana | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22588748 | Background | 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. | |
| 35994942 |
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Individual participant data (IPD) that underlie the results reported in publications (de-identified dataset including primary and secondary outcome variables) will be shared. No information that could identify participants will be included. Data dictionaries and statistical codes may also be made available upon reasonable request for academic and research purposes. Access will be granted after publication and following institutional data-sharing agreements.
De-identified individual participant data will be available beginning 6-12 months after publication of the primary results and for a period of up to 3 years thereafter.
Researchers seeking access to the data will be required to submit a methodologically sound proposal and sign a data-use agreement to ensure confidentiality and compliance with ethical standards. Requests will be evaluated by the study investigators and relevant institutional authorities.
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Participants will be randomly assigned to one of three parallel study arms: (1) paravertebral block, (2) external oblique intercostal block, or (3) intravenous patient-controlled analgesia (PCA) with tramadol. Each participant will receive only the intervention assigned to their group, and no crossover between groups will occur. Outcomes will be assessed over the first 24 postoperative hours following laparoscopic cholecystectomy.
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The investigator assessing postoperative pain scores will be blinded to the intervention group allocation. Patients and anesthesia providers will not be blinded.
| External Oblique Intercostal Block (EOI Block) | Procedure | 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) | Drug | 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. |
|
|
Presence of nausea and/or vomiting requiring antiemetic treatment. |
| Within 24 hours postoperatively |
| Incidence of block-related complications | Presence of complications related to the regional block (e.g., vascular puncture, pneumothorax, local anesthetic systemic toxicity). | Intraoperative and first 24 hours after block |
| Patient satisfaction with analgesia | Patient-reported satisfaction score for pain management (0 = very dissatisfied, 10 = very satisfied). | 24 hours postoperatively |
| Background |
| 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. |
| 30635518 | Background | 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. |
| 30339615 | Background | 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. |
| 26356102 | Background | 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. |
| 30236241 | Background | 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. |
| 33796423 | Background | 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. |
| 25205408 | Background | 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. |
| 39369396 | Background | 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. |
| 36345156 | Background | 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. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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