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Postoperative PainNCT07241949

External Oblique Intercostal Block (EOICB) for Laparoscopic Cholecystectomy

A study testing Paravertebral Block (PVB) and External Oblique Intercostal Block (EOI Block) in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Cukurova University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Paravertebral Block (PVB) and External Oblique Intercostal Block (EOI Block)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2025to 5 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 65 years
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • ASA physical status I-III
  • Able to understand the study procedure and provide informed consent

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Cukurova University Faculty of Medicine

    Adana

    Nurefsan Sadikoglu, MD, + (90) 538 926 2414, nurefsansadikoglu@gmail.com

    Zehra Hatipoglu, MD, +(90) 532 447 1670, hatipogluzehra@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Paravertebral Block or External Oblique Intercostal Block? A Comparative Analysis of Pain and Opioid Consumption After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

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.

Read the detailed description

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.

Being tested
Paravertebral Block (PVB), External Oblique Intercostal Block (EOI Block), Tramadol IV Patient-Controlled Analgesia (PCA)
Keywords
Cholecystectomy, Pain, Analgesia, Tramadol, Nerve Block
Medical subject headings
Pain, Postoperative, Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paravertebral Block (PVB)Procedure or surgery

    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)Procedure or surgery

    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

    Also called Control group

    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.

Study groups in NCT07241949
Study groupRoleWhat they receive
Paravertebral Block GroupActive comparatorParticipants 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.
Receives: Procedure: Paravertebral Block (PVB)
External Oblique Intercostal Block GroupActive comparatorParticipants 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.
Receives: Procedure: External Oblique Intercostal Block (EOI Block)
Control Group - IV PCA TramadolActive comparatorParticipants 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.
Receives: Drug: Tramadol IV Patient-Controlled Analgesia (PCA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-hour postoperative tramadol consumption

    Total amount of intravenous tramadol administered via PCA within the first 24 hours after surgery.

    Measured: Within the first 24 hours after surgery.

Secondary outcomes (4)
  1. 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.

    Measured: 1, 6, 12, and 24 hours postoperatively

  2. Incidence of postoperative nausea and vomiting

    Presence of nausea and/or vomiting requiring antiemetic treatment.

    Measured: Within 24 hours postoperatively

  3. Incidence of block-related complications

    Presence of complications related to the regional block (e.g., vascular puncture, pneumothorax, local anesthetic systemic toxicity).

    Measured: Intraoperative and first 24 hours after block

  4. Patient satisfaction with analgesia

    Patient-reported satisfaction score for pain management (0 = very dissatisfied, 10 = very satisfied).

    Measured: 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study start1 Dec 2025
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion5 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
147 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07241949
Sponsor's protocol ID
2024-KAEK-33
Status last verified
Jun 2026
First submitted
17 Nov 2025
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 22588748
  • 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.

    PubMed 35994942
  • 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.

    PubMed 30635518
  • 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.

    PubMed 30339615
  • 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.

    PubMed 26356102
  • 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.

    PubMed 30236241
  • 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.

    PubMed 33796423
  • 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.

    PubMed 25205408
  • 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.

    PubMed 39369396
  • 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.

    PubMed 36345156

Questions about this trial

What is this clinical trial studying?

A study testing Paravertebral Block (PVB) and External Oblique Intercostal Block (EOI Block) in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Cukurova University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nurefsan Sadikoglu, MD (+(90) 538 926 2414, nurefsansadikoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour postoperative tramadol consumption (time frame: Within the first 24 hours after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07241949, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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