Postoperative PainNCT07057934
Comparative Efficacy of ESPB and EOPB for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Randomized Controlled Trial (External Oblique Intercostal Plan Block (EOPB) and Erector Spina Plan Block (ESPB) )
A study testing ESPB Block, EOPB Block and Standard Systemic Analgesia in people with Postoperative Pain and Cholelithiasis, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial investigates the comparative efficacy of two novel regional anesthesia techniques - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy under… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Cholelithiasis, Acute Pain
- What is being tested?
- ESPB Block, EOPB Block and Standard Systemic Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Jun 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- ASA physical status I-II
- Undergoing elective laparoscopic cholecystectomy under general anesthesia
- Provided informed written consent
- BMI between 18.5 and 30 kg/m²
- Able to follow study instructions
Who cannot join
- Allergy to local anesthetics
- Chronic opioid use or chronic pain
- Coagulopathy or anticoagulant use
- Severe organ dysfunction
- Pregnancy or breastfeeding
- Neurological or psychiatric disorders
- Infection at injection site
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK AND ERECTOR SPINA PLAN BLOCK ON POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY OPERATION
This randomized controlled clinical trial investigates the comparative efficacy of two novel regional anesthesia techniques - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
A total of 90 patients aged 18-65 years, with ASA physical status I or II, were randomly assigned to one of three groups: ESPB, EOPB, or control. Blocks were performed under ultrasound guidance prior to surgical incision. Pain intensity was evaluated using the Visual Analog Scale (VAS), and rescue analgesic consumption was recorded over the first 24 hours postoperatively.
The study aims to determine whether ESPB or EOPB offers superior pain control and reduced opioid consumption, and to assess patient satisfaction and safety. The results will inform multimodal analgesia strategies for upper abdominal laparoscopic surgery.
Read the detailed description
Laparoscopic cholecystectomy (LC) is one of the most commonly performed upper abdominal surgeries. Despite being minimally invasive, LC is frequently associated with significant postoperative pain originating from both visceral and somatic sources. Inadequate pain control may lead to delayed recovery, increased opioid consumption, and patient dissatisfaction.
Regional anesthesia techniques have become increasingly important components of multimodal analgesia protocols for abdominal surgeries. Two recently described fascial plane blocks - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - have shown promising results in reducing postoperative pain in thoracic and abdominal procedures.
This prospective, randomized, controlled clinical trial was conducted to evaluate and compare the analgesic effectiveness of ESPB and EOPB in patients undergoing elective LC under general anesthesia. After obtaining ethical approval (Protocol No: 2024/17/840-938) and informed consent, 90 adult patients aged 18-65 years with ASA physical status I or II were enrolled.
Participants were randomized into three groups using a sealed envelope technique:
Group 1 (ESPB): Received bilateral ultrasound-guided ESPB at the T7-8 level using 20 mL of local anesthetic solution (10 mL 0.5% bupivacaine + 10 mL 2% lidocaine) preoperatively.
Group 2 (EOPB): Received ultrasound-guided EOPB using the same volume and mixture of local anesthetic.
Group 3 (Control): Did not receive any regional block.
Postoperative pain was assessed using the Visual Analog Scale (VAS) at regular intervals (15 minutes, and at 2, 4, 8, 12, 16, and 24 hours). Rescue analgesia consisted of 50 mg dexketoprofen trometamol administered when VAS ≥4. If pain persisted, 50 mg tramadol was given as a second-line analgesic.
Primary endpoints included postoperative VAS scores and total rescue analgesic consumption over 24 hours. Secondary endpoints included time to first analgesic requirement, side effects, complications related to blocks, and patient satisfaction.
Initial results indicated that both ESPB and EOPB significantly reduced postoperative pain and analgesic requirements compared to the control group. While EOPB was technically easier to perform, ESPB provided longer-lasting analgesia. These findings may support the integration of ESPB or EOPB into routine multimodal analgesia protocols for laparoscopic abdominal surgeries.
- Conditions
- Postoperative Pain, Cholelithiasis, Acute Pain
- Being tested
- ESPB Block, EOPB Block, Standard Systemic Analgesia
- Keywords
- Laparoscopic Cholecystectomy, Regional Anesthesia, Erector Spinae Plane Block, External Oblique Intercostal Plane Block, Multimodal Analgesia
- Medical subject headings
- Pain, Postoperative, Cholelithiasis, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPB BlockProcedure or surgery
Under sterile conditions and ultrasound guidance, 20 mL of local anesthetic solution (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected bilaterally into the erector spinae plane at the T7-T8 level before incision. The block was performed after induction of general anesthesia but before the start of laparoscopic cholecystectomy.
EOPB BlockProcedure or surgery
Under ultrasound guidance, 20 mL of local anesthetic mixture (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected into the fascial plane between the external oblique and internal intercostal muscles at the level of the 6th rib. The procedure was done after anesthesia induction but prior to laparoscopic cholecystectomy.
Standard Systemic AnalgesiaDrug
No regional anesthesia technique was applied. Postoperative pain was managed using systemic rescue analgesia: 50 mg dexketoprofen trometamol IV when VAS ≥4, followed by 50 mg tramadol IV if pain persisted.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Experimental | Participants in this group received a bilateral ultrasound-guided erector spinae plane block (ESPB) at the T7-T8 vertebral level under general anesthesia prior to surgical incision.
Under sterile conditions and ultrasound guidance, 20 mL of local anesthetic solution (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected bilaterally into the erector spinae plane at the T7-T8 level before incision. The block was performed after induction of general anesthesia but before the start of laparoscopic cholecystectomy. Receives: Procedure: ESPB Block |
| External Oblique Intercostal Plane Block (EOPB) | Experimental | Participants in this group received an external oblique intercostal plane block (EOPB) under ultrasound guidance prior to surgical incision.
Under ultrasound guidance, 20 mL of local anesthetic mixture (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected into the fascial plane between the external oblique and internal intercostal muscles at the level of the 6th rib. The procedure was done after anesthesia induction but prior to laparoscopic cholecystectomy. Receives: Procedure: EOPB Block |
| Control Group | Other | Participants in this group did not receive any regional block. Postoperative analgesia was provided via standard systemic medications as needed.
No regional anesthesia technique was applied. Postoperative pain was managed using systemic rescue analgesia: 50 mg dexketoprofen trometamol IV when VAS ≥4, followed by 50 mg tramadol IV if pain persisted. Receives: Drug: Standard Systemic Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity (VAS Score)
Postoperative pain will be measured using the Visual Analog Scale (VAS), where patients rate their pain on a 0-10 scale (0 = no pain, 10 = worst imaginable pain).
Measured: 0-24 hours postoperatively (measured at 15 min, 2, 4, 8, 12, 16, and 24 hours)
Total Rescue Analgesic Consumption (Dexketoprofen + Tramadol)
Total cumulative dose of rescue analgesics administered within the first 24 hours postoperatively will be recorded. Dexketoprofen (mg) and tramadol (mg) will be summed for each participant.
Measured: 0-24 hours postoperatively
Secondary outcomes (4)
Time to First Rescue Analgesic Requirement
The time elapsed from the end of surgery to the administration of the first dose of rescue analgesic (dexketoprofen) will be recorded for each participant.
Measured: 0-24 hours postoperatively
Patient Satisfaction Score
Patient satisfaction with pain management will be assessed at 24 hours using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Measured: At 24 hours postoperatively
Incidence of Block-Related Complications
Incidence of complications related to regional blocks (e.g., local anesthetic toxicity, hematoma, nerve injury, pneumothorax) will be monitored and recorded.
Measured: Intraoperative and within 24 hours postoperative
Intraoperative Opioid Requirement
Total intraoperative fentanyl dose (in mcg) administered during the procedure will be recorded.
Measured: Intraoperative period (during surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- This is a single-center, prospective, randomized, controlled, parallel-group clinical trial involving 90 patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Participants were randomly allocated into three groups: ESPB Group: Patients received a bilateral erector spinae plane block at the T7-T8 level prior to surgical incision. EOPB Group: Patients received an external oblique intercostal plane block at the 6th rib level. Control Group: Patients received no regional block. All participants were monitored for postoperative pain scores and analgesic consumption over 24 hours.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aykut Aydin, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057934
- Sponsor's protocol ID
- SBÜ-KLKH-AR-2024-ESPB-EOPB-01
- Other IDs
- 2024/17/840-938
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 10 Jul 2025
- 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. The study was conducted as part of a postgraduate academic thesis, and ethical approval limits data use to the original analysis only. No public data repository or external sharing is planned.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK AND ERECTOR SPINA PLAN BLOCK ON POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY OPERATION
- ClinicalTrials.gov ID
- NCT07057934
- Acronym / sponsor ID
- SBÜ-KLKH-AR-2024-ESPB-EOPB-01
- Conditions
- Postoperative Pain, Cholelithiasis, Acute Pain
- Keywords
- Laparoscopic Cholecystectomy, Regional Anesthesia, Erector Spinae Plane Block, External Oblique Intercostal Plane Block, Multimodal Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical trial investigates the comparative efficacy of two novel regional anesthesia techniques - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
A total of 90 patients aged 18-65 years, with ASA physical status I or II, were randomly assigned to one of three groups: ESPB, EOPB, or control. Blocks were performed under ultrasound guidance prior to surgical incision. Pain intensity was evaluated using the Visual Analog Scale (VAS), and rescue analgesic consumption was recorded over the first 24 hours postoperatively.
The study aims to determine whether ESPB or EOPB offers superior pain control and reduced opioid consumption, and to assess patient satisfaction and safety. The results will inform multimodal analgesia strategies for upper abdominal laparoscopic surgery.
Detailed description
Laparoscopic cholecystectomy (LC) is one of the most commonly performed upper abdominal surgeries. Despite being minimally invasive, LC is frequently associated with significant postoperative pain originating from both visceral and somatic sources. Inadequate pain control may lead to delayed recovery, increased opioid consumption, and patient dissatisfaction.
Regional anesthesia techniques have become increasingly important components of multimodal analgesia protocols for abdominal surgeries. Two recently described fascial plane blocks - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - have shown promising results in reducing postoperative pain in thoracic and abdominal procedures.
This prospective, randomized, controlled clinical trial was conducted to evaluate and compare the analgesic effectiveness of ESPB and EOPB in patients undergoing elective LC under general anesthesia. After obtaining ethical approval (Protocol No: 2024/17/840-938) and informed consent, 90 adult patients aged 18-65 years with ASA physical status I or II were enrolled.
Participants were randomized into three groups using a sealed envelope technique:
Group 1 (ESPB): Received bilateral ultrasound-guided ESPB at the T7-8 level using 20 mL of local anesthetic solution (10 mL 0.5% bupivacaine + 10 mL 2% lidocaine) preoperatively.
Group 2 (EOPB): Received ultrasound-guided EOPB using the same volume and mixture of local anesthetic.
Group 3 (Control): Did not receive any regional block.
Postoperative pain was assessed using the Visual Analog Scale (VAS) at regular intervals (15 minutes, and at 2, 4, 8, 12, 16, and 24 hours). Rescue analgesia consisted of 50 mg dexketoprofen trometamol administered when VAS ≥4. If pain persisted, 50 mg tramadol was given as a second-line analgesic.
Primary endpoints included postoperative VAS scores and total rescue analgesic consumption over 24 hours. Secondary endpoints included time to first analgesic requirement, side effects, complications related to blocks, and patient satisfaction.
Initial results indicated that both ESPB and EOPB significantly reduced postoperative pain and analgesic requirements compared to the control group. While EOPB was technically easier to perform, ESPB provided longer-lasting analgesia. These findings may support the integration of ESPB or EOPB into routine multimodal analgesia protocols for laparoscopic abdominal surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- This is a single-center, prospective, randomized, controlled, parallel-group clinical trial involving 90 patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Participants were randomly allocated into three groups: ESPB Group: Patients received a bilateral erector spinae plane block at the T7-T8 level prior to surgical incision. EOPB Group: Patients received an external oblique intercostal plane block at the 6th rib level. Control Group: Patients received no regional block. All participants were monitored for postoperative pain scores and analgesic consumption over 24 hours.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Experimental | Procedure: ESPB BlockParticipants in this group received a bilateral ultrasound-guided erector spinae plane block (ESPB) at the T7-T8 vertebral level under general anesthesia prior to surgical incision. Under sterile conditions and ultrasound guidance, 20 mL of local anesthetic solution (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected bilaterally into the erector spinae plane at the T7-T8 level before incision. The block was performed after induction of general anesthesia but before the start of laparoscopic cholecystectomy. |
| External Oblique Intercostal Plane Block (EOPB) | Experimental | Procedure: EOPB BlockParticipants in this group received an external oblique intercostal plane block (EOPB) under ultrasound guidance prior to surgical incision. Under ultrasound guidance, 20 mL of local anesthetic mixture (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected into the fascial plane between the external oblique and internal intercostal muscles at the level of the 6th rib. The procedure was done after anesthesia induction but prior to laparoscopic cholecystectomy. |
| Control Group | Other | Drug: Standard Systemic AnalgesiaParticipants in this group did not receive any regional block. Postoperative analgesia was provided via standard systemic medications as needed. No regional anesthesia technique was applied. Postoperative pain was managed using systemic rescue analgesia: 50 mg dexketoprofen trometamol IV when VAS ≥4, followed by 50 mg tramadol IV if pain persisted. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 years
- ASA physical status I-II
- Undergoing elective laparoscopic cholecystectomy under general anesthesia
- Provided informed written consent
- BMI between 18.5 and 30 kg/m²
Key exclusion criteria (8 listed)
- Allergy to local anesthetics
- Chronic opioid use or chronic pain
- Coagulopathy or anticoagulant use
- Severe organ dysfunction
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESPB BlockUnder sterile conditions and ultrasound guidance, 20 mL of local anesthetic solution (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected bilaterally into the erector spinae plane at the T7-T8 level before incision. The block was performed after induction of general anesthesia but before the start of laparoscopic cholecystectomy. | Procedure or surgery | Erector Spinae Plane Block (ESPB) |
| EOPB BlockUnder ultrasound guidance, 20 mL of local anesthetic mixture (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected into the fascial plane between the external oblique and internal intercostal muscles at the level of the 6th rib. The procedure was done after anesthesia induction but prior to laparoscopic cholecystectomy. | Procedure or surgery | External Oblique Intercostal Plane Block (EOPB) |
| Standard Systemic AnalgesiaNo regional anesthesia technique was applied. Postoperative pain was managed using systemic rescue analgesia: 50 mg dexketoprofen trometamol IV when VAS ≥4, followed by 50 mg tramadol IV if pain persisted. | Drug | Control Group |
Primary outcome
Postoperative Pain Intensity (VAS Score)
Time frame: 0-24 hours postoperatively (measured at 15 min, 2, 4, 8, 12, 16, and 24 hours)
Postoperative pain will be measured using the Visual Analog Scale (VAS), where patients rate their pain on a 0-10 scale (0 = no pain, 10 = worst imaginable pain).
Total Rescue Analgesic Consumption (Dexketoprofen + Tramadol)
Time frame: 0-24 hours postoperatively
Total cumulative dose of rescue analgesics administered within the first 24 hours postoperatively will be recorded. Dexketoprofen (mg) and tramadol (mg) will be summed for each participant.
4 secondary outcomes
Time to First Rescue Analgesic Requirement
Time frame: 0-24 hours postoperatively
Patient Satisfaction Score
Time frame: At 24 hours postoperatively
Incidence of Block-Related Complications
Time frame: Intraoperative and within 24 hours postoperative
Intraoperative Opioid Requirement
Time frame: Intraoperative period (during surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study was conducted as part of a postgraduate academic thesis, and ethical approval limits data use to the original analysis only. No public data repository or external sharing is planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPB Block, EOPB Block and Standard Systemic Analgesia in people with Postoperative Pain and Cholelithiasis, run by Dr. Lutfi Kirdar Kartal 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 6 inclusion and 8 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 10 Jul 2025. 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?
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?
Postoperative Pain Intensity (VAS Score) (time frame: 0-24 hours postoperatively (measured at 15 min, 2, 4, 8, 12, 16, and 24 hours)). The study lists 2 primary outcomes in all. 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 10 Jul 2025.