Postoperative PainNCT07834086
Superficial Plane Blocks for Analgesia After Laparoscopic Cholecystectomy
An observational study of Postoperative Pain and Laparoscopic Cholecystectomy, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-center observational study will evaluate postoperative analgesia in adults undergoing elective laparoscopic cholecystectomy. Participants will receive routine anesthetic care selected by the responsible anesthesiologist and will be observed in one of three groups: rectointercostal plane block… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain, Laparoscopic Cholecystectomy
- What is being tested?
- Rectointercostal Plane Block and External Oblique-Rectus Abdominis Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Sep 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults scheduled for elective laparoscopic cholecystectomy at Bursa Yuksek Ihtisas Training and Research Hospital who receive one of three routine postoperative analgesic approaches selected by the responsible anesthesiologist: rectointercostal plane block, EXORA block, or intravenous patient-controlled analgesia.
Who may be able to join
- Age 18 to 85 years
- Scheduled to undergo elective laparoscopic cholecystectomy
- American Society of Anesthesiologists physical status I, II, or III
- Provision of written informed consent
Who cannot join
- Age younger than 18 years or older than 85 years
- Known allergy to local anesthetics
- Coagulopathy
- Presence of infection
- Pregnancy
- Cognitive impairment
- Body mass index greater than 35 kg/m²
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
About this study
Official title: Postoperative Analgesic Effectiveness of Superficial Plane Blocks in Laparoscopic Cholecystectomy: A Prospective Observational Study
This prospective, single-center observational study will evaluate postoperative analgesia in adults undergoing elective laparoscopic cholecystectomy. Participants will receive routine anesthetic care selected by the responsible anesthesiologist and will be observed in one of three groups: rectointercostal plane block, external oblique-rectus abdominis plane (EXORA) block, or intravenous patient-controlled analgesia (IV PCA). The study will compare postoperative pain scores and sensory block spread. Pain at rest and with movement will be assessed using the 0-to-10 Numeric Rating Scale at 0, 2, 4, 6, 12, and 24 hours after surgery. Sensory spread will be assessed by pinprick testing across the T4-T12 dermatomes at 30 minutes after surgery. Additional assessments will include 24-hour tramadol consumption, postoperative nausea and vomiting, and block-related complications.
Read the detailed description
The study will prospectively enroll 90 adults aged 18 to 85 years who are scheduled for elective laparoscopic cholecystectomy at Bursa Yuksek Ihtisas Training and Research Hospital. The choice of postoperative analgesic technique will be made by the responsible anesthesiologist as part of routine clinical care; the investigators will not assign participants to an analgesic technique. Participants will be evaluated according to the routine care they receive: rectointercostal plane block, EXORA block, or intravenous patient-controlled analgesia. Investigators will record demographic and clinical characteristics, operative and anesthetic information, the analgesic technique used, local anesthetic type and volume when applicable, and tramadol use. Pain at rest and during movement will be measured with the Numeric Rating Scale at 0, 2, 4, 6, 12, and 24 hours postoperatively. For participants receiving a plane block, dermatomal sensory spread from T4 through T12 will be assessed by pinprick testing at 30 minutes after surgery. The study will also record cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and block-related complications.
- Conditions
- Postoperative Pain, Laparoscopic Cholecystectomy
- Being tested
- Rectointercostal Plane Block, External Oblique-Rectus Abdominis Plane Block, Intravenous Patient-Controlled Analgesia With Tramadol
- Keywords
- Rectointercostal Plane Block, EXORA Block, Numeric Rating Scale, Tramadol, Patient-Controlled 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.
Rectointercostal Plane BlockProcedure or surgery
Ultrasound-guided rectointercostal plane block used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care.
External Oblique-Rectus Abdominis Plane BlockProcedure or surgery
Also called EXORA Block
Ultrasound-guided external oblique-rectus abdominis plane (EXORA) block used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care.
Intravenous Patient-Controlled Analgesia With TramadolDrug
Also called IV PCA With Tramadol
Intravenous patient-controlled analgesia with tramadol used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Rectointercostal Plane Block Group | Participants who receive a rectointercostal plane block as selected by the responsible anesthesiologist during routine clinical care. Receives: Procedure: Rectointercostal Plane Block; Drug: Intravenous Patient-Controlled Analgesia With Tramadol | |
| EXORA Block Group | Participants who receive an external oblique-rectus abdominis plane (EXORA) block as selected by the responsible anesthesiologist during routine clinical care. Receives: Procedure: External Oblique-Rectus Abdominis Plane Block; Drug: Intravenous Patient-Controlled Analgesia With Tramadol | |
| Intravenous Patient-Controlled Analgesia Group | Participants managed with intravenous patient-controlled analgesia as selected by the responsible anesthesiologist during routine clinical care. Receives: Drug: Intravenous Patient-Controlled Analgesia With Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity at Rest and With Movement
Participant-reported pain intensity will be measured separately at rest and during movement using an 11-point Numeric Rating Scale ranging from 0 to 10, with higher scores indicating greater pain.
Measured: 0, 2, 4, 6, 12, and 24 hours after surgery
Secondary outcomes (4)
Sensory Block Distribution Assessed by Pinprick
In participants who receive a plane block, sensory block distribution will be assessed by pinprick testing across the T4 through T12 dermatomes. Dermatomes demonstrating reduced pinprick sensation will be recorded.
Measured: 30 minutes after surgery
Cumulative Tramadol Consumption
Total tramadol consumption, measured in milligrams, will be recorded during the first 24 postoperative hours.
Measured: During the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
The number and percentage of participants who experience postoperative nausea and/or vomiting will be recorded.
Measured: During the first 24 hours after surgery
Incidence of Block-Related Complications
Among participants who receive a plane block, the number and percentage who experience any complication considered related to the block procedure will be recorded.
Measured: During the first 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 posted22 Sep 2026
- Study start1 Mar 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834086
- Sponsor's protocol ID
- 2024-TBEK 2026/02-02
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Effectiveness of Superficial Plane Blocks in Laparoscopic Cholecystectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07834086
- Acronym / sponsor ID
- 2024-TBEK 2026/02-02
- Conditions
- Postoperative Pain, Laparoscopic Cholecystectomy
- Keywords
- Rectointercostal Plane Block, EXORA Block, Numeric Rating Scale, Tramadol, Patient-Controlled Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 22 Sep 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, single-center observational study will evaluate postoperative analgesia in adults undergoing elective laparoscopic cholecystectomy. Participants will receive routine anesthetic care selected by the responsible anesthesiologist and will be observed in one of three groups: rectointercostal plane block, external oblique-rectus abdominis plane (EXORA) block, or intravenous patient-controlled analgesia (IV PCA). The study will compare postoperative pain scores and sensory block spread. Pain at rest and with movement will be assessed using the 0-to-10 Numeric Rating Scale at 0, 2, 4, 6, 12, and 24 hours after surgery. Sensory spread will be assessed by pinprick testing across the T4-T12 dermatomes at 30 minutes after surgery. Additional assessments will include 24-hour tramadol consumption, postoperative nausea and vomiting, and block-related complications.
Detailed description
The study will prospectively enroll 90 adults aged 18 to 85 years who are scheduled for elective laparoscopic cholecystectomy at Bursa Yuksek Ihtisas Training and Research Hospital. The choice of postoperative analgesic technique will be made by the responsible anesthesiologist as part of routine clinical care; the investigators will not assign participants to an analgesic technique. Participants will be evaluated according to the routine care they receive: rectointercostal plane block, EXORA block, or intravenous patient-controlled analgesia. Investigators will record demographic and clinical characteristics, operative and anesthetic information, the analgesic technique used, local anesthetic type and volume when applicable, and tramadol use. Pain at rest and during movement will be measured with the Numeric Rating Scale at 0, 2, 4, 6, 12, and 24 hours postoperatively. For participants receiving a plane block, dermatomal sensory spread from T4 through T12 will be assessed by pinprick testing at 30 minutes after surgery. The study will also record cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and block-related complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rectointercostal Plane Block Group | – | Procedure: Rectointercostal Plane Block, Drug: Intravenous Patient-Controlled Analgesia With TramadolParticipants who receive a rectointercostal plane block as selected by the responsible anesthesiologist during routine clinical care. |
| EXORA Block Group | – | Procedure: External Oblique-Rectus Abdominis Plane Block, Drug: Intravenous Patient-Controlled Analgesia With TramadolParticipants who receive an external oblique-rectus abdominis plane (EXORA) block as selected by the responsible anesthesiologist during routine clinical care. |
| Intravenous Patient-Controlled Analgesia Group | – | Drug: Intravenous Patient-Controlled Analgesia With TramadolParticipants managed with intravenous patient-controlled analgesia as selected by the responsible anesthesiologist during routine clinical care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults scheduled for elective laparoscopic cholecystectomy at Bursa Yuksek Ihtisas Training and Research Hospital who receive one of three routine postoperative analgesic approaches selected by the responsible anesthesiologist: rectointercostal plane block, EXORA block, or intravenous patient-controlled analgesia.
Key inclusion criteria (4 listed)
- Age 18 to 85 years
- Scheduled to undergo elective laparoscopic cholecystectomy
- American Society of Anesthesiologists physical status I, II, or III
- Provision of written informed consent
Key exclusion criteria (7 listed)
- Age younger than 18 years or older than 85 years
- Known allergy to local anesthetics
- Coagulopathy
- Presence of infection
- Pregnancy
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 |
|---|---|---|
| Rectointercostal Plane BlockUltrasound-guided rectointercostal plane block used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care. | Procedure or surgery | Rectointercostal Plane Block Group |
| External Oblique-Rectus Abdominis Plane BlockAlso: EXORA BlockUltrasound-guided external oblique-rectus abdominis plane (EXORA) block used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care. | Procedure or surgery | EXORA Block Group |
| Intravenous Patient-Controlled Analgesia With TramadolAlso: IV PCA With TramadolIntravenous patient-controlled analgesia with tramadol used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care. | Drug | EXORA Block Group, Intravenous Patient-Controlled Analgesia Group, Rectointercostal Plane Block Group |
Primary outcome
Postoperative Pain Intensity at Rest and With Movement
Time frame: 0, 2, 4, 6, 12, and 24 hours after surgery
Participant-reported pain intensity will be measured separately at rest and during movement using an 11-point Numeric Rating Scale ranging from 0 to 10, with higher scores indicating greater pain.
4 secondary outcomes
Sensory Block Distribution Assessed by Pinprick
Time frame: 30 minutes after surgery
Cumulative Tramadol Consumption
Time frame: During the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
Time frame: During the first 24 hours after surgery
Incidence of Block-Related Complications
Time frame: During the first 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 22 Sep 2026.
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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 and Laparoscopic Cholecystectomy, run by Bursa Yuksek Ihtisas 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 4 inclusion and 7 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 22 Sep 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 at Rest and With Movement (time frame: 0, 2, 4, 6, 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?
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 22 Sep 2026.