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External Oblique Intercostal BlockNCT07377877

External Oblique Intercostal Block vs Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy

A study testing Ultrasound-Guided External Oblique Intercostal Block and Ultrasound-Guided Erector Spinae Plane Block in people with External Oblique Intercostal Block and Erector Spina Plan Block, run by Karabuk University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled study aims to compare the effects of the external oblique intercostal block (EOIB) and the erector spinae plane block (ESPB) on postoperative analgesia in adult patients undergoing elective laparoscopic cholecystectomy. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ultrasound-Guided External Oblique Intercostal Block and Ultrasound-Guided Erector Spinae Plane Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Jan 2026to 15 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 80 years
  • Scheduled to undergo elective laparoscopic cholecystectomy
  • Classified as American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to understand and operate a patient-controlled analgesia (PCA) device
  • Provision of written informed consent

Who cannot join

  • History of chronic opioid use for more than four weeks prior to surgery
  • Presence of pre-existing chronic pain conditions, such as migraine or fibromyalgia
  • History of alcohol or substance abuse
  • Known hypersensitivity or allergy to local anesthetics or opioids
  • Presence of severe organ dysfunction, including clinically significant hepatic or renal disease
  • Any contraindication to regional anesthesia
Show all 9Show fewer
  • Severe psychiatric disorders impairing patient cooperation or the ability to reliably assess pain (e.g., psychosis, dementia)
  • Pregnancy or breastfeeding
  • Presence of hematological disorders

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Karabuk Training and Research Hospital, Department of Anesthesiology and Reanimation

    Karabük, 78200

  • Department of Anesthesiology and Reanimation, Samsun City Hospital

    Samsun, 55200

Other trials in Turkey (Türkiye)

About this study

Official title: Ultrasound-Guided External Oblique Intercostal Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Study

This randomized controlled study aims to compare the effects of the external oblique intercostal block (EOIB) and the erector spinae plane block (ESPB) on postoperative analgesia in adult patients undergoing elective laparoscopic cholecystectomy. Both EOIB and ESPB are ultrasound-guided regional anesthesia techniques currently used in clinical practice to improve postoperative pain control as part of multimodal analgesia strategies.

Laparoscopic cholecystectomy is a common minimally invasive surgical procedure; however, patients may still experience postoperative pain that can increase opioid consumption and delay recovery. Identifying the most effective regional anesthesia technique may improve postoperative analgesia and patient recovery.

In this study, eligible patients will be randomly assigned to receive either bilateral EOIB or bilateral ESPB in addition to standardized general anesthesia and postoperative patient-controlled analgesia. Postoperative pain scores, opioid consumption, quality of recovery, postoperative nausea and vomiting, and block-related complications will be evaluated during the first 24 hours after surgery. The study aims to provide comparative clinical evidence regarding the analgesic effectiveness of these two regional anesthesia techniques.

Read the detailed description

This study is designed as a multicenter, prospective, randomized controlled trial aiming to evaluate and compare the postoperative analgesic outcomes of two ultrasound-guided regional anesthesia techniques, external oblique intercostal block (EOIB) and erector spinae plane block (ESPB), in adult patients undergoing elective laparoscopic cholecystectomy.EOIB and ESPB are ultrasound-guided regional anesthesia techniques that have been described for postoperative analgesia in upper abdominal surgery. In this study, the regional analgesic technique to be administered will be determined by randomization, while all other aspects of perioperative care will follow standard institutional practice. Except for the randomized allocation of the regional block technique, the research team will not alter routine anesthetic management.

The primary objective of the study is to compare cumulative intravenous morphine consumption during the first 24 hours after surgery between patients receiving EOIB and those receiving ESPB. Secondary objectives include assessment of postoperative pain scores at rest and during movement, quality of recovery, postoperative nausea and vomiting (PONV), intraoperative opioid consumption, rescue analgesic requirements, block-related complications, and opioid-related adverse effects.

Clinical Routine and Analgesic Protocol

All patients will be managed according to the standard multimodal analgesia protocol routinely used in the general surgery operating rooms of the participating institutions. Preoperatively, standard ASA monitoring will be applied, intravenous access will be established, and perioperative fluid management will be provided according to institutional practice. Mild sedation will be administered using intravenous midazolam at a dose of 0.02 mg/kg. Supplemental oxygen will be delivered via nasal cannula during block performance.

General anesthesia will be induced and maintained using routinely applied anesthetic agents. Intraoperative opioid administration will be titrated according to hemodynamic parameters to maintain mean arterial pressure and heart rate within acceptable limits, and total intraoperative opioid consumption will be recorded.

Postoperatively, all patients will receive intravenous paracetamol and intravenous tramadol as part of routine analgesic care. Intravenous morphine patient-controlled analgesia (PCA) will be provided to all patients using standardized settings, including a 1 mg bolus dose, a 10-minute lockout interval, and a 4-hour limit of 20 mg. Rescue analgesia will consist of intravenous tramadol infusion when pain remains uncontrolled (NRS ≥4), followed by intravenous morphine if necessary, according to the predefined protocol.

Block Techniques (Performed as Part of Study Protocol)

EOIB Group:

Patients allocated to the EOIB group will receive bilateral ultrasound-guided external oblique intercostal block approximately 45 minutes before surgery. With the patient in the supine position, a high-frequency linear ultrasound probe will be placed longitudinally along the anterior midaxillary line. Using an in-plane approach, a block needle will be advanced into the fascial plane deep to the external oblique muscle. A total volume of 30 mL of 0.25% bupivacaine will be administered bilaterally. The block will be performed by experienced anesthesiologists.

ESPB Group:

Patients allocated to the ESPB group will receive bilateral ultrasound-guided erector spinae plane block approximately 45 minutes before surgery. With the patient in the sitting position, following skin disinfection and sterile preparation, a convex ultrasound probe will be placed in a sagittal orientation approximately 2-3 cm lateral to the T7 spinous process. Using an in-plane approach, the needle will be advanced into the fascial plane deep to the erector spinae muscle. A total volume of 30 mL of 0.25% bupivacaine will be administered bilaterally, with sonographic confirmation of cranial and caudal spread.

Postoperative Assessment

Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS; 0-10) at rest and during movement (deep breathing or coughing) at 0, 3, 6, 12, 18, and 24 hours after surgery. PONV will be evaluated using a verbal descriptive scale, and antiemetic treatment will be administered as needed according to institutional protocols.

Quality of recovery and patient satisfaction will be assessed using the Turkish version of the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours postoperatively. Intraoperative opioid consumption, time to first PCA demand, rescue analgesic requirements, block-related complications (including pneumothorax, hematoma, vascular puncture, epidural spread, intrathecal injection, and local anesthetic systemic toxicity), and opioid-related side effects such as nausea, sedation, and respiratory depression will be recorded.

Dermatomal sensory block distribution will be assessed using a pinprick test with a 27-gauge needle 30 minutes after block application.

All data will be collected by trained personnel blinded to group allocation. Due to the low-risk nature of the interventions and the short follow-up period, no independent data monitoring committee has been established.

Being tested
Ultrasound-Guided External Oblique Intercostal Block, Ultrasound-Guided Erector Spinae Plane Block
Keywords
External Oblique Intercostal Block, Erector Spinae Plane Block, Laparoscopic Cholecystectomy, Ultrasound-Guided Nerve Block
Medical subject headings
Agnosia

What participants receive

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

  • Ultrasound-Guided External Oblique Intercostal BlockProcedure or surgery

    Bilateral ultrasound-guided external oblique intercostal block performed approximately 45 minutes before surgery. A total of 60 mL of 0.25% bupivacaine (30 mL per side) is injected into the fascial plane deep to the external oblique muscle.

  • Ultrasound-Guided Erector Spinae Plane BlockProcedure or surgery

    Bilateral ultrasound-guided erector spinae plane block performed approximately 45 minutes before surgery. A total of 60 mL of 0.25% bupivacaine (30 mL per side) is injected into the fascial plane deep to the erector spinae muscle at the thoracic level under ultrasound guidance.

Study groups in NCT07377877
Study groupRoleWhat they receive
Group EOIBActive comparatorPatients allocated to the EOIB group will be transferred to the regional anesthesia area and monitored approximately 45 minutes before surgery. With the patient in the supine position, bilateral ultrasound-guided external oblique intercostal block (EOIB) will be performed. A total volume of 60 mL of 0.25% bupivacaine (30 mL per side) will be injected. General anesthesia will then be administered according to standard practice. In the postoperative period, additional analgesia will be provided using intravenous morphine patient-controlled analgesia (PCA).
Receives: Procedure: Ultrasound-Guided External Oblique Intercostal Block
Group ESPBActive comparatorPatients allocated to the ESPB group will be transferred to the regional anesthesia area and monitored approximately 45 minutes before surgery. With the patient in the supine position, bilateral ultrasound-guided erector spinae plane block (ESPB) will be performed. A total volume of 60 mL of 0.25% bupivacaine (30 mL per side) will be injected. General anesthesia will then be administered according to standard practice. In the postoperative period, additional analgesia will be provided using intravenous morphine patient-controlled analgesia (PCA).
Receives: Procedure: Ultrasound-Guided Erector Spinae Plane Block

What is being measured

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

  1. 24-hour cumulative opioid consumption

    Total opioid consumption within the first 24 hours, including PCA-administered morphine and rescue analgesics converted to morphine milligram equivalents (MME).

    Measured: postoperative day 1

Secondary outcomes (9)
  1. 12-hour cumulative opioid consumption

    Total opioid consumption within the first 12 hours, including PCA-administered morphine and rescue analgesics converted to MME.

    Measured: postoperative 12th hour

  2. Postoperative pain scores (NRS at rest)

    Pain status at rest will be assessed by numeric rating scale (NRS) score at 0, 3, 6, 12, 18 and 24 hours after surgery. In addition, the time until the first analgesic requirement will be recorded. The NRS is an 11-point numeric scale that ranges from 0 to 10.

    Measured: postoperative day 1

  3. Postoperative pain scores (NRS during activity)

    Pain status during activity will be assessed by numeric rating scale (NRS) score at 0, 3, 6, 12, 18 and 24 hours after surgery. In addition, the time until the first analgesic requirement will be recorded. The NRS is an 11-point numeric scale that ranges from 0 to 10.

    Measured: postoperative day 1

  4. Patient-reported quality of recovery (QoR-15 score)

    Quality of recovery will be assessed using the validated 15-item Quality of Recovery questionnaire (QoR-15). Each item is scored on an 11-point numeric scale (0-10), resulting in a total score ranging from 0 to 150, with higher scores indicating better postoperative recovery.

    Measured: postoperative day 1

  5. Postoperative nausea and vomiting incidence (PONV)

    The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18 and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required (The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once).

    Measured: Postoperative day 1

  6. Time to first PCA analgesic demand

    Time at which the first analgesic is requested

    Measured: Postoperative day 1

  7. Number of patients requiring rescue analgesia

    The number of patients requiring rescue analgesia due to inadequate postoperative pain control (Numeric Rating Scale [NRS] ≥4) despite standard analgesic management

    Measured: Postoperative day 1

  8. Block-related complications

    Incidence of complications such as bleeding, hematoma, or local anesthetic systemic toxicity (LAST)

    Measured: Postoperative day 7

  9. Opioid-related adverse effects

    Presence of itching, sedation, fatigue, or respiratory depression related to opioid use.

    Measured: Postoperative day 7

Timeline

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

  1. First posted30 Jan 2026
  2. Study start1 Jan 2026
  3. Primary completion1 Apr 2026
  4. Study completion15 Apr 2026

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 in a 1:1 ratio to receive either external oblique intercostal block or erector spinae plane block, and outcomes will be compared between two parallel intervention groups.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07377877
Sponsor's protocol ID
EOIBESP2026
Status last verified
May 2026
First submitted
21 Jan 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared outside the study team, as the dataset contains sensitive clinical information and data sharing was not included in the original informed consent. Data will be used solely for the purposes of the current study and related scientific publications, in accordance with institutional policies and ethical regulations.

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided External Oblique Intercostal Block and Ultrasound-Guided Erector Spinae Plane Block in people with External Oblique Intercostal Block and Erector Spina Plan Block, run by Karabuk University at 2 sites 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour cumulative opioid consumption (time frame: postoperative day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 May 2026.

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