Postoperative PainNCT07788911
External Oblique Intercostal Plane Block With or Without Rectus Sheath Block After Laparoscopic Cholecystectomy
An observational study of Postoperative Pain, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study compared postoperative pain outcomes in patients undergoing laparoscopic cholecystectomy who received bilateral external oblique intercostal plane block (EOIPB) alone or bilateral EOIPB combined with bilateral rectus sheath block (RSB). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bilateral External Oblique Intercostal Plane Block and Bilateral Rectus Sheath Block
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 26 Apr 2026
- Phase
- Observational
- 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
Study population: Adult patients aged 18 to 70 years with American Society of Anesthesiologists physical status I to III who underwent laparoscopic cholecystectomy were included. Participants were observed in two cohorts according to the regional block technique selected and performed by the attending anesthesiologist as part of routine clinical care.
Who may be able to join
- Adults aged 18 to 70 years
- American Society of Anesthesiologists physical status I to III
- Scheduled to undergo laparoscopic cholecystectomy
- Received bilateral EOIPB alone or bilateral EOIPB combined with bilateral RSB as part of routine clinical care
- Provided written informed consent to participate
Who cannot join
- Contraindication to regional block procedures, including coagulopathy, anticoagulant use, or local infection at the needle insertion site
- Known severe cardiovascular, renal, or hepatic disease
- Life-threatening hematological disease
- Neurological disease or psychiatric disorder
- Known allergy to the medications used in the study or to amide-type local anesthetics
- History of chronic pain
Show all 10Show fewer
- History of narcotic substance or alcohol dependence
- Body mass index of 35 kg/m² or greater
- Pregnancy
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34147
About this study
Official title: Comparison of Bilateral External Oblique Intercostal Plane Block With and Without Bilateral Rectus Sheath Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Prospective Observational Cohort Study
This prospective observational cohort study compared postoperative pain outcomes in patients undergoing laparoscopic cholecystectomy who received bilateral external oblique intercostal plane block (EOIPB) alone or bilateral EOIPB combined with bilateral rectus sheath block (RSB). The block technique was selected by the attending anesthesiologist as part of routine clinical practice and was not assigned by the researchers.
Postoperative pain intensity was assessed using a 0-10 visual analog scale at 1, 2, 4, 8, 12, and 24 hours after surgery. Intraoperative remifentanil consumption, postoperative rescue analgesic consumption, hemodynamic measurements, postoperative nausea and vomiting, other analgesic-related adverse effects, and patient satisfaction were also evaluated during the first 24 postoperative hours.
Read the detailed description
Regional fascial plane blocks are used as part of multimodal analgesia after laparoscopic abdominal surgery. The external oblique intercostal plane block may provide analgesia to the upper anterior and lateral abdominal wall, while the addition of a rectus sheath block may improve analgesic coverage of the anterior abdominal wall.
This single-center prospective observational cohort study included 104 adult patients undergoing laparoscopic cholecystectomy. Patients were observed in two cohorts according to the regional anesthesia technique they received during routine clinical care: bilateral EOIPB alone or bilateral EOIPB combined with bilateral RSB. The attending anesthesiologist selected and performed the block technique independently of the study investigators. The investigators did not randomize participants or assign the regional anesthesia technique.
The primary objective was to compare postoperative pain intensity between the two cohorts using a 0-10 visual analog scale at 1, 2, 4, 8, 12, and 24 hours after surgery. Secondary assessments included intraoperative remifentanil consumption, postoperative rescue analgesic consumption during the first 24 hours, perioperative hemodynamic measurements, postoperative nausea and vomiting, other analgesic-related adverse effects, and patient satisfaction.
Routine perioperative anesthetic management and the standard postoperative analgesic regimen were similar in both cohorts. Additional rescue analgesics were administered according to individual clinical need, and the total rescue analgesic consumption during the first 24 postoperative hours was recorded. All study assessments were completed during the first 24 hours after surgery.
- Conditions
- Postoperative Pain
- Being tested
- Bilateral External Oblique Intercostal Plane Block, Bilateral Rectus Sheath Block
- Keywords
- Laparoscopic Cholecystectomy, External Oblique Intercostal Plane Block, Rectus Sheath Block, Regional Anesthesia, Postoperative Analgesia
- 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 Intercostal Plane BlockProcedure or surgery
Also called EOIPB
Under ultrasound guidance, bilateral external oblique intercostal plane block was performed using a total of 40 mL of 0.25% bupivacaine solution, with 20 mL administered on each side. The final solution was prepared by mixing 20 mL of 0.5% bupivacaine with 20 mL of normal saline, corresponding to a total bupivacaine dose of 100 mg. The procedure was selected and performed by the attending anesthesiologist as part of routine clinical practice, independently of the study investigators.
Bilateral Rectus Sheath BlockProcedure or surgery
Also called RSB
Under ultrasound guidance, bilateral rectus sheath block was performed using a total of 20 mL of 0.25% bupivacaine solution, with 10 mL administered on each side. The final solution was prepared by mixing 10 mL of 0.5% bupivacaine with 10 mL of normal saline, corresponding to a total bupivacaine dose of 50 mg. The procedure was selected and performed by the attending anesthesiologist as part of routine clinical practice, independently of the study investigators.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral EOIPB Cohort | Participants who received bilateral external oblique intercostal plane block as part of routine clinical care. The block technique was selected and performed by the attending anesthesiologist independently of the study investigators. No rectus sheath block was performed in this cohort. Receives: Procedure: Bilateral External Oblique Intercostal Plane Block | |
| Bilateral EOIPB Combined With Bilateral RSB Cohort | Participants who received bilateral external oblique intercostal plane block combined with bilateral rectus sheath block as part of routine clinical care. Both block procedures were selected and performed by the attending anesthesiologist independently of the study investigators. Receives: Procedure: Bilateral External Oblique Intercostal Plane Block; Procedure: Bilateral Rectus Sheath Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed by Visual Analog Scale
Postoperative pain intensity was assessed using a 0-10 visual analog scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were compared between the two cohorts.
Measured: At 1, 2, 4, 8, 12, and 24 hours after surgery
Secondary outcomes (3)
Total Intraoperative Remifentanil Consumption
The total cumulative dose of remifentanil administered during surgery was recorded in milligrams and compared between the two cohorts.
Measured: From induction of anesthesia to the end of surgery
Total Postoperative Opioid Consumption
The total cumulative dose of intravenous tramadol administered as rescue analgesia was recorded in milligrams and compared between the two cohorts.
Measured: During the first 24 hours after surgery
Patient Satisfaction With Postoperative Analgesia
Patient satisfaction with postoperative pain management was assessed using a 5-point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Scores were compared between the two cohorts.
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start15 May 2025
- Primary completion26 Apr 2026
- Study completion26 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788911
- Sponsor's protocol ID
- EOIPB-RSB-OBS-2025-01
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because an IPD-sharing plan was not included in the approved study protocol or informed consent documents.
Publications
Hamilton DL, Manickam BP, Wilson MAJ, Abdel Meguid E. External oblique fascial plane block. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100256. doi: 10.1136/rapm-2018-100256. Online ahead of print. No abstract available.
PubMed 30635518Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
PubMed 34626112Kitamura N, Iida H, Maehira H, Mori H, Sada Y, Shimizu T, Kitagawa H, Tani M. Postoperative analgesic effect of ultrasound-guided rectus sheath block and local anesthetic infiltration after laparoscopic cholecystectomy: Results of a prospective randomized controlled trial. Asian J Endosc Surg. 2022 Jan;15(1):29-35. doi: 10.1111/ases.12957. Epub 2021 Jun 22.
PubMed 34159732
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bilateral External Oblique Intercostal Plane Block With and Without Bilateral Rectus Sheath Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07788911
- Acronym / sponsor ID
- EOIPB-RSB-OBS-2025-01
- Conditions
- Postoperative Pain
- Keywords
- Laparoscopic Cholecystectomy, External Oblique Intercostal Plane Block, Rectus Sheath Block, Regional Anesthesia, Postoperative Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 15 May 2025 (actual)
- Primary completion
- 26 Apr 2026 (actual)
- Study completion
- 26 Apr 2026 (actual)
- First posted
- 27 Aug 2026 (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 prospective observational cohort study compared postoperative pain outcomes in patients undergoing laparoscopic cholecystectomy who received bilateral external oblique intercostal plane block (EOIPB) alone or bilateral EOIPB combined with bilateral rectus sheath block (RSB). The block technique was selected by the attending anesthesiologist as part of routine clinical practice and was not assigned by the researchers.
Postoperative pain intensity was assessed using a 0-10 visual analog scale at 1, 2, 4, 8, 12, and 24 hours after surgery. Intraoperative remifentanil consumption, postoperative rescue analgesic consumption, hemodynamic measurements, postoperative nausea and vomiting, other analgesic-related adverse effects, and patient satisfaction were also evaluated during the first 24 postoperative hours.
Detailed description
Regional fascial plane blocks are used as part of multimodal analgesia after laparoscopic abdominal surgery. The external oblique intercostal plane block may provide analgesia to the upper anterior and lateral abdominal wall, while the addition of a rectus sheath block may improve analgesic coverage of the anterior abdominal wall.
This single-center prospective observational cohort study included 104 adult patients undergoing laparoscopic cholecystectomy. Patients were observed in two cohorts according to the regional anesthesia technique they received during routine clinical care: bilateral EOIPB alone or bilateral EOIPB combined with bilateral RSB. The attending anesthesiologist selected and performed the block technique independently of the study investigators. The investigators did not randomize participants or assign the regional anesthesia technique.
The primary objective was to compare postoperative pain intensity between the two cohorts using a 0-10 visual analog scale at 1, 2, 4, 8, 12, and 24 hours after surgery. Secondary assessments included intraoperative remifentanil consumption, postoperative rescue analgesic consumption during the first 24 hours, perioperative hemodynamic measurements, postoperative nausea and vomiting, other analgesic-related adverse effects, and patient satisfaction.
Routine perioperative anesthetic management and the standard postoperative analgesic regimen were similar in both cohorts. Additional rescue analgesics were administered according to individual clinical need, and the total rescue analgesic consumption during the first 24 postoperative hours was recorded. All study assessments were completed during the first 24 hours after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral EOIPB Cohort | – | Procedure: Bilateral External Oblique Intercostal Plane BlockParticipants who received bilateral external oblique intercostal plane block as part of routine clinical care. The block technique was selected and performed by the attending anesthesiologist independently of the study investigators. No rectus sheath block was performed in this cohort. |
| Bilateral EOIPB Combined With Bilateral RSB Cohort | – | Procedure: Bilateral External Oblique Intercostal Plane Block, Procedure: Bilateral Rectus Sheath BlockParticipants who received bilateral external oblique intercostal plane block combined with bilateral rectus sheath block as part of routine clinical care. Both block procedures were selected and performed by the attending anesthesiologist independently of the study investigators. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 to 70 years with American Society of Anesthesiologists physical status I to III who underwent laparoscopic cholecystectomy were included. Participants were observed in two cohorts according to the regional block technique selected and performed by the attending anesthesiologist as part of routine clinical care.
Key inclusion criteria (5 listed)
- Adults aged 18 to 70 years
- American Society of Anesthesiologists physical status I to III
- Scheduled to undergo laparoscopic cholecystectomy
- Received bilateral EOIPB alone or bilateral EOIPB combined with bilateral RSB as part of routine clinical care
- Provided written informed consent to participate
Key exclusion criteria (10 listed)
- Contraindication to regional block procedures, including coagulopathy, anticoagulant use, or local infection at the needle insertion site
- Known severe cardiovascular, renal, or hepatic disease
- Life-threatening hematological disease
- Neurological disease or psychiatric disorder
- Known allergy to the medications used in the study or to amide-type local anesthetics
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 |
|---|---|---|
| Bilateral External Oblique Intercostal Plane BlockAlso: EOIPBUnder ultrasound guidance, bilateral external oblique intercostal plane block was performed using a total of 40 mL of 0.25% bupivacaine solution, with 20 mL administered on each side. The final solution was prepared by mixing 20 mL of 0.5% bupivacaine with 20 mL of normal saline, corresponding to a total bupivacaine dose of 100 mg. The procedure was selected and performed by the attending anesthesiologist as part of routine clinical practice, independently of the study investigators. | Procedure or surgery | Bilateral EOIPB Cohort, Bilateral EOIPB Combined With Bilateral RSB Cohort |
| Bilateral Rectus Sheath BlockAlso: RSBUnder ultrasound guidance, bilateral rectus sheath block was performed using a total of 20 mL of 0.25% bupivacaine solution, with 10 mL administered on each side. The final solution was prepared by mixing 10 mL of 0.5% bupivacaine with 10 mL of normal saline, corresponding to a total bupivacaine dose of 50 mg. The procedure was selected and performed by the attending anesthesiologist as part of routine clinical practice, independently of the study investigators. | Procedure or surgery | Bilateral EOIPB Combined With Bilateral RSB Cohort |
Primary outcome
Postoperative Pain Intensity Assessed by Visual Analog Scale
Time frame: At 1, 2, 4, 8, 12, and 24 hours after surgery
Postoperative pain intensity was assessed using a 0-10 visual analog scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were compared between the two cohorts.
3 secondary outcomes
Total Intraoperative Remifentanil Consumption
Time frame: From induction of anesthesia to the end of surgery
Total Postoperative Opioid Consumption
Time frame: During the first 24 hours after surgery
Patient Satisfaction With Postoperative Analgesia
Time frame: At 24 hours after 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 27 Aug 2026.
- Background: PubMed 30635518Hamilton DL, Manickam BP, Wilson MAJ, Abdel Meguid E. External oblique fascial plane block. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100256. doi: 10.1136/rapm-2018-100256. Online ahead of print. No abstract available.
- Background: PubMed 34626112Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
- Background: PubMed 34159732Kitamura N, Iida H, Maehira H, Mori H, Sada Y, Shimizu T, Kitagawa H, Tani M. Postoperative analgesic effect of ultrasound-guided rectus sheath block and local anesthetic infiltration after laparoscopic cholecystectomy: Results of a prospective randomized controlled trial. Asian J Endosc Surg. 2022 Jan;15(1):29-35. doi: 10.1111/ases.12957. Epub 2021 Jun 22.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because an IPD-sharing plan was not included in the approved study protocol or informed consent documents.
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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?
An observational study of Postoperative Pain, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 5 inclusion and 10 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 27 Aug 2026. 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 Assessed by Visual Analog Scale (time frame: At 1, 2, 4, 8, 12, and 24 hours after surgery). 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 NCT07788911, which also lists 3 linked publications.
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 27 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.