ClinicalTrials.gg
Not yet recruitingNCT07935694Updated Nov 13, 2026

ESPB Versus Combined PIPB and RIB for Analgesia in Minimally Invasive Cardiac Surgery

An interventional study of Erector Spinae Plane Block (ESPB) and Combined Parasternal Intercostal Plane Block (PIPB) and Rhomboid Intercostal Block (RIB) in Postoperative Pain, sponsored by Ankara Etlik City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Ankara Etlik City Hospital · Not applicable, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Pain, Postoperative by Ankara Etlik City Hospital — 5 open to participants now, 6 under way, none of them phase 3. Pain, Postoperative · Ankara Etlik City Hospital.

Started
2026
with 6 others
No phase
9 of 13
4 open now
Registered
13th of 13
by date

Among the 13 studies in Pain, Postoperative by Ankara Etlik City Hospital, this one is one of 7 that started in 2026, is one of 9 with no phase, and was the 13th registered.

Pain, Postoperative

5,648 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

5 of the 13 studies in Pain, Postoperative by Ankara Etlik City Hospital are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study summary

Pain after minimally invasive cardiac surgery can affect breathing, movement, and recovery. Regional anesthesia techniques may help reduce postoperative pain and the need for opioid pain medications.

This study aims to compare two ultrasound-guided regional anesthesia approaches for pain management after minimally invasive cardiac surgery: erector spinae plane block (ESPB) and a combination of parasternal intercostal plane block (PIPB) and rhomboid intercostal block (RIB).

A total of 56 adult patients undergoing minimally invasive cardiac surgery will be randomly assigned to one of two groups. One group will receive ESPB, while the other group will receive the combined PIPB and RIB technique. Both approaches will use the same total dose of local anesthetic and will be performed after induction of general anesthesia and before surgery.

The main objective is to compare how pain scores at rest change between the two groups during the first 12 hours after removal of the breathing tube. Pain will be assessed using a numerical scale from 0 (no pain) to 10 (worst imaginable pain).

The study will also evaluate postoperative opioid consumption, additional pain measurements, quality of recovery, and block-related adverse events. Quality of recovery will be assessed using the QoR-15T questionnaire before surgery and 48 hours after extubation.Patient-reported acceptability of postoperative pain management will also be evaluated using a Likert scale at 48 hours postoperatively.

The findings may help identify effective regional anesthesia strategies for postoperative pain management in minimally invasive cardiac surgery.

Read the detailed description

Postoperative pain management is an important component of enhanced recovery after minimally invasive cardiac surgery (MICS). Although minimally invasive approaches avoid conventional median sternotomy, patients may experience substantial pain related to the thoracic incision, intercostal tissue injury, and chest drains.

Ultrasound-guided regional anesthesia techniques are increasingly used as part of multimodal analgesia in cardiac surgery. The erector spinae plane block (ESPB) is a fascial plane block that may provide analgesia through the spread of local anesthetic across multiple thoracic segments. The combined parasternal intercostal plane block (PIPB) and rhomboid intercostal block (RIB) approach targets different regions of the thoracic wall and may provide complementary analgesic coverage.

This prospective, single-center, randomized controlled trial will compare the postoperative analgesic efficacy of unilateral ESPB with combined PIPB and RIB in 56 adult patients undergoing minimally invasive cardiac surgery.

Following induction of general anesthesia and before surgical incision, patients will receive one of two ultrasound-guided regional anesthesia approaches. The ESPB group will receive 30 mL of 0.25% bupivacaine on the surgical side. The combined-block group will receive 15 mL of 0.25% bupivacaine for PIPB and 15 mL of 0.25% bupivacaine for RIB. The total local anesthetic dose will be identical between groups.

All patients will receive standardized perioperative care and multimodal postoperative analgesia, including acetaminophen and patient-controlled tramadol analgesia.

The primary outcome will be the between-group difference in the trajectory of resting Numeric Rating Scale (NRS) pain scores at 0, 2, 4, 8, and 12 hours after extubation, evaluated through the group-by-time interaction.

Secondary outcomes will include postoperative pain measurements at additional time points, cumulative tramadol consumption during the first 24 hours, time to first rescue analgesia, postoperative quality of recovery assessed using the Turkish version of the Quality of Recovery-15 questionnaire (QoR-15T),Patient-reported acceptability of postoperative pain management will also be assessed using a Likert scale at 48 hours postoperatively and block-related adverse events.

The study aims to determine whether the combined PIPB and RIB approach offers a clinically useful alternative to ESPB for postoperative analgesia after minimally invasive cardiac surgery.

03

Conditions studied

  • Postoperative Pain

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Keywords

  • Minimally Invasive Cardiac Surgery
  • Erector Spinae Plane Block
  • Parasternal Intercostal Plane Block
  • Rhomboid Intercostal Block
  • Regional Anesthesia
  • Postoperative Analgesia
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18-80 years.
  • Patients scheduled for elective minimally invasive cardiac surgery (MICS).
  • (ASA) physical status I-III.
  • (BMI) between 18 and 35 kg/m².
  • Ability to communicate adequately in Turkish and participate in postoperative pain assessments.
  • Provision of written .

Exclusion criteria

Exclusion Criteria:

  • Age younger than 18 years or older than 80 years.
  • IV.
  • below 18 or above 35 kg/m².
  • Severe hepatic or renal dysfunction.
  • Pregnancy or breastfeeding.
  • Dementia, psychiatric disorders, or cognitive impairment preventing reliable cooperation or pain assessment.
  • Language barriers preventing effective communication.
  • History of alcohol, substance, or medication dependence.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
56 participants (estimated)

Study arms

  • Active comparator
    Erector Spinae Plane Block (ESPB) group

    Patients allocated to this group will receive a unilateral ultrasound-guided erector spinae plane block (ESPB) at the T5 vertebral level on the surgical side after induction of general anesthesia and before surgical incision. A total of 30 mL of 0.25% bupivacaine (75 mg) will be administered.

    Procedure: Erector Spinae Plane Block (ESPB)

  • Experimental
    Combined Parasternal Intercostal Plane Block and Rhomboid Intercostal Block

    Patients allocated to this group will receive a combination of ultrasound-guided parasternal intercostal plane block (PIPB) and rhomboid intercostal block (RIB) after induction of general anesthesia and before surgical incision. A total of 15 mL of 0.25% bupivacaine will be administered for PIPB and 15 mL of 0.25% bupivacaine for RIB on the surgical side. The total local anesthetic volume will be 30 mL (75 mg).

    Procedure: Combined Parasternal Intercostal Plane Block (PIPB) and Rhomboid Intercostal Block (RIB)

Interventions

  • ProcedureErector Spinae Plane Block (ESPB)

    An ultrasound-guided unilateral erector spinae plane block (ESPB) will be performed at the T5 vertebral level on the surgical side after induction of general anesthesia and before surgical incision. A total of 30 mL of 0.25% bupivacaine (75 mg) will be injected into the fascial plane between the erector spinae muscle and the transverse process.

  • ProcedureCombined Parasternal Intercostal Plane Block (PIPB) and Rhomboid Intercostal Block (RIB)

    Following induction of general anesthesia and before surgical incision, patients will receive two ultrasound-guided fascial plane blocks on the surgical side. A parasternal intercostal plane block (PIPB) will be performed with 15 mL of 0.25% bupivacaine, followed by a rhomboid intercostal block (RIB) with 15 mL of 0.25% bupivacaine injected between the rhomboid major and intercostal muscles. The total administered volume will be 30 mL of 0.25% bupivacaine (75 mg).

06

What researchers measure

Primary outcomes

  1. Postoperative Resting Pain Scores Assessed by the Numeric Rating Scale (NRS)

    Postoperative pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Measurements will be obtained at 0, 2, 4, 8, and 12 hours after extubation. The primary outcome will be the group-by-time interaction in resting NRS scores, comparing the erector spinae plane block (ESPB) group with the combined parasternal intercostal plane block and rhomboid intercostal block (PIPB + RIB) group using a repeated-measures statistical approach.

    Time frame: At 0, 2, 4, 8, and 12 hours after extubation

Secondary outcomes

  1. Cumulative Postoperative Tramadol Consumption Within 24 Hours

    Total tramadol consumption (mg) during the first 24 hours after extubation will be recorded. Postoperative patient-controlled analgesia (PCA) will be provided using tramadol with a 10 mg bolus dose, a 10-minute lockout interval, and no basal infusion. Cumulative tramadol consumption will be compared between the ESPB and combined PIPB + RIB groups. Higher consumption indicates greater postoperative opioid requirements.

    Time frame: From extubation to 24 hours after extubation

  2. Postoperative Pain Score at Rest at 24 Hours

    Postoperative pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at 24 hours after extubation and compared between the ESPB and combined PIPB + RIB groups. Higher scores indicate greater pain intensity.

    Time frame: 24 hours after extubation

  3. Change in Quality of Recovery-15 Turkish Version (QoR-15T) Score

    Quality of postoperative recovery will be assessed using the validated Turkish version of the 15-item Quality of Recovery questionnaire (QoR-15T). The questionnaire evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10, yielding a total score ranging from 0 to 150, with higher scores indicating better recovery quality. The QoR-15T will be administered preoperatively and at 48 hours after extubation. The change in total score from baseline to 48 hours will be compared between the ESPB and combined PIPB + RIB groups.

    Time frame: Preoperatively (baseline) and 48 hours after extubation

  4. Patient-Reported Acceptability of Postoperative Pain Management at 48 Hours

    Patient-reported acceptability of postoperative pain management will be assessed using a five-point Likert scale at 48 hours after extubation. Patients will rate their agreement with the statement, "The level of pain I experienced after surgery was acceptable to me." Responses will be scored as follows: 1 = Strongly disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, and 5 = Strongly agree. Higher scores indicate greater acceptability of postoperative pain management. The distribution of responses will be compared between the ESPB and combined PIPB + RIB groups.

    Time frame: 48 hours after extubation

  5. Time to First Rescue Analgesia

    Time elapsed from extubation to the first administration of rescue analgesia, measured in minutes.

    Time frame: Within 24 hours after extubation

  6. Incidence of Block-related Adverse Events

    Number of participants experiencing block-related adverse events, including pneumothorax and local anesthetic systemic toxicity.

    Time frame: Within 24 hours after block administration

  7. Postoperative Pain Score During Movement at 24 Hours

    Postoperative pain intensity during movement will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at 24 hours after extubation and compared between the ESPB and combined PIPB + RIB groups. Higher scores indicate greater pain intensity.

    Time frame: 24 hours after extubation

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Mar 2027, 3 months later.

Of 2,094 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 3 months is below that.

Counting every sponsor, half of 2,107 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2026
First posted
Nov 13, 2026
StartEst.
Dec 2026
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07935694
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Dec 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Havva SAYHAN KAPLAN
Contact
hsayhan@gmail.com
+905056621021
havva sayhan kaplan, MD
principal investigator · Ankara Etlik City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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