NCT07377877

Brief 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. 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 21, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

External Oblique Intercostal BlockErector Spinae Plane BlockLaparoscopic CholecystectomyUltrasound-Guided Nerve Block

Outcome Measures

Primary Outcomes (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).

    postoperative day 1

Secondary Outcomes (9)

  • 12-hour cumulative opioid consumption

    postoperative 12th hour

  • Postoperative pain scores (NRS at rest)

    postoperative day 1

  • Postoperative pain scores (NRS during activity)

    postoperative day 1

  • Patient-reported quality of recovery (QoR-15 score)

    postoperative day 1

  • Postoperative nausea and vomiting incidence (PONV)

    Postoperative day 1

  • +4 more secondary outcomes

Study Arms (2)

Group EOIB

ACTIVE COMPARATOR

Patients 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).

Procedure: Ultrasound-Guided External Oblique Intercostal Block

Group ESPB

ACTIVE COMPARATOR

Patients 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).

Procedure: Ultrasound-Guided Erector Spinae Plane Block

Interventions

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.

Group EOIB

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.

Group ESPB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Severe psychiatric disorders impairing patient cooperation or the ability to reliably assess pain (e.g., psychosis, dementia)
  • Pregnancy or breastfeeding
  • Presence of hematological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karabuk Training and Research Hospital, Department of Anesthesiology and Reanimation

Karabük, 78200, Turkey (Türkiye)

RECRUITING

Department of Anesthesiology and Reanimation, Samsun City Hospital

Samsun, 55200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elif Sarikaya Ozel, M.D.

    Karabuk Training and Research Hospital, Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Sarikaya Ozel, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Block randomization lists will be generated using Microsoft Office 365 Excel (Microsoft, Redmond, WA, USA), and patients will be randomly assigned to one of the two study groups in a 1:1 ratio. According to the randomization result, group allocation will be placed in sealed opaque envelopes. Forty-five minutes before block performance, an independent nurse who is not involved in the study will deliver the envelope containing group assignment to the anesthesiologist performing the regional block. Patients, surgeons, ward nurses, and all personnel involved in postoperative data collection and outcome assessment will remain blinded to group allocation. Investigators responsible for outcome evaluation and statistical analysis will also be blinded to the randomization results. To ensure block quality and standardization, all regional blocks will be performed by a single experienced anesthesiologist who has performed each block technique at least 30 times. For masking purposes, this anesth
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator- M.D. Karabuk Training and Research Hospital, Department of Anesthesiology

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 30, 2026

Study Start

January 1, 2026

Primary Completion

April 1, 2026

Study Completion

April 15, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations