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Laparoscopic CholecystectomyNCT05536557

Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy.

A study testing Bilateral External Oblique İntercostal (EOI) Plane Block and Standard perioperative and postoperative multimodal analgesia in people with Laparoscopic Cholecystectomy, run by Karaman Training and Research Hospital at 1 site 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 study will define the postoperative analgesic effect of ultrasound-guided bilateral External Oblique İntercostal (EOI) Plane Block and compare the control group in patients undergoing laparoscopic cholecystectomy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Laparoscopic Cholecystectomy
What is being tested?
Bilateral External Oblique İntercostal (EOI) Plane Block and Standard perioperative and postoperative multimodal analgesia
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2022to 24 Nov 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study.

Who cannot join

  • presence of coagulation disorder
  • infection at the injection site of the block
  • known allergy to local anesthetics
  • advanced hepatic or renal failure
  • can not communicate in Turkish
  • history of abdominal surgery or trauma
Show all 12Show fewer
  • conversion of laparoscopic to open surgery
  • consumption of any pain killers within the 24 h before the operation
  • chronic opioid consumption
  • pregnancy
  • alcohol or drug abuse
  • body mass index (BMI) ≥ 35 kg m-2.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Karaman Taining and Research Hospital

    Karaman, 70200

Other trials in Turkey (Türkiye)

About this study

Official title: Ultrasound-guided Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Controlled Trial

This study will define the postoperative analgesic effect of ultrasound-guided bilateral External Oblique İntercostal (EOI) Plane Block and compare the control group in patients undergoing laparoscopic cholecystectomy.

The aim of this study is to compare postoperative opioid consumption of EOI plane block versus control group. It is hypothesized that postoperative opioid use will be less in patients with EOI plane block than in patients who only receive routine multimodal analgesia.

Read the detailed description

Laparoscopy is a minimally invasive procedure, but postoperative pain is still the most common symptom after laparoscopic cholecystectomy (LC). Regional blocks used in addition to multimodal analgesia for postoperative pain after LC usually block the anterior branches of the intercostal nerves. After it was suggested by Hamilton et al. in 2018 that it could block the lateral cutaneous branches between T7-T11 intercostal nerve by administering local anesthetic to the thoracic facial plane and could be used in lateral abdominal surgeries, the EOI plane block has become a block that can be used for analgesic purposes in upper and lateral abdominal surgeries. Blocking the anterior and lateral branches together may produce analgesia in a wider area, resulting in less postoperative opioid consumption.

This study will be conducted as a single-center, prospective, randomized trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, EOI Plane Block will be performed under ultrasound guidance after administering general anesthesia and prior to the skin incision. An anesthesiologist who performed blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative opioid consumption,pain scores, nausea and vomiting, antiemetic use, and Quality of Recovery score will be blinded to group assignment.

Being tested
Bilateral External Oblique İntercostal (EOI) Plane Block, Standard perioperative and postoperative multimodal analgesia
Keywords
Laparoscopic Cholecystectomy, Acute Postoperative Pain, Nerve block
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Bilateral External Oblique İntercostal (EOI) Plane BlockOther

    Also called Quality of Recovery-15 score, Standard Pain Followup and Monitorization

    External Oblique İntercostal (EOI) Plane Block will be provided for postoperative pain for Laparoscopic Cholecystectomy with Bupivacaine. And patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.

  • Standard perioperative and postoperative multimodal analgesiaOther

    Also called Quality of Recovery-15 score, Standard Pain Followup and Monitorization

    Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol for Laparoscopic Cholecystectomy.

Study groups in NCT05536557
Study groupRoleWhat they receive
Group (EOI) Plane BlockActive comparatorAfter tracheal intubation, a high-frequency linear probe will be in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle identified at the level ribs 6 and 7 in line. A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to EOI plane. The same procedure will be repeated on the contralateral side. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.
Receives: Other: Bilateral External Oblique İntercostal (EOI) Plane Block
Group NSham comparatorThe patients in Group N will not receive any intervention. In the intervention and control groups, block sites will be covered with dressings, and patients and other health care workers will be blinded to treatment allocation. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.
Receives: Other: Standard perioperative and postoperative multimodal analgesia

What is being measured

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

  1. Opioid consumption

    If NRS score of the patient is equal or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.

    Measured: Postoperative 24 hours

Secondary outcomes (6)

  1. Numerical Rating Scale scores

    The primary outcome variable is Numerical Rating Scale scores both at rest and motion. A blinded anesthesiologist will assess postoperative pain during rest and motion at the postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).

    Measured: Postoperative 24 hours

  2. Time to first rescue analgesic

    The time for administration of first rescue analgesic.

    Measured: Postoperative 24 hours

  3. Adverse events

    Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.

    Measured: Postoperative 24 hours

  4. Metoclopromide consumption

    The severity of the nausea will be assessed on a 4 -point scale (0=none 1=mild, 2=moderate 3=severe). If the patients nausea score is ≥2 the patient will receive 10 mg metoclopromide.

    Measured: Postoperative 24 hours

  5. Sedation score

    Sedation level of the patients will be assessed on a 4-point scale (0=alert, 1=sleepy, easy to arouse verbally, 2= drowsy, 3=does not open eyes to verbal commands) at postoperative 15th,30th and 60th minute, second, 6th, 12th and 24th hour.

    Measured: Postoperative 24 hour

  6. Quality of recovery levels between groups by using QoR-15 questionnaire

    A 15-parameter Quality of Recovery score (QoR-15) has been recommended as the optimum tool to evaluate overall patient-centers measures of recovery after surgery, including pain. It is a questionnaire that is given to patients to do postoperatively and is scored from 0 to 150 where 150 indicates that the patient has had an excellent recovery QoR-15 score will be recorded on the morning of operation and at the postoperative 24th hour.

    Measured: Postoperative 24th hour

Timeline

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

  1. First posted13 Sep 2022
  2. Study start15 Sep 2022
  3. Primary completion23 Nov 2022
  4. Study completion24 Nov 2022

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
There are two group; 1. Experimental Group: Group (EOI) Plane Block ; A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to EOI plane. The same procedure will be repeated on the contralateral side. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol. 2. Sham Comparator Group:The patients will not receive any intervention. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05536557
Sponsor's protocol ID
02-2022/11
Status last verified
Nov 2022
First submitted
6 Sep 2022
Last updated
28 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Korkusuz M, Basaran B, Et T, Bilge A, Yarimoglu R, Yildirim H. Bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. Saudi Med J. 2023 Oct;44(10):1037-1046. doi: 10.15537/smj.2023.44.10.20230350.

    PubMed 37777270

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral External Oblique İntercostal (EOI) Plane Block and Standard perioperative and postoperative multimodal analgesia in people with Laparoscopic Cholecystectomy, run by Karaman Training and Research Hospital 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 1 inclusion and 12 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 28 Nov 2022. 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. Some participants in this study may receive a placebo. 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?

Opioid consumption (time frame: Postoperative 24 hours). 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 NCT05536557, which also lists 1 linked publication.

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 28 Nov 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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