Laparoskopic CholecystectomyNCT07003698
Postoperative Analgesic Efficacy of Recto Intercostal Nerve Block
A study testing The group without the rectointercostal nerve block and The rectointercostal plane block in people with Laparoskopic Cholecystectomy and Recto Intercostal Nerve Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is a frequently performed surgery and the gold standard for the treatment of symptomatic gallstone disease. Although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoskopic Cholecystectomy, Recto Intercostal Nerve Block
- What is being tested?
- The group without the rectointercostal nerve block and The rectointercostal plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2025to 28 Apr 2026
- 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
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Elective laparoscopic cholecystectomy surgery
Who cannot join
- Under 18 and over 65 years old
- ASA score IV and above
- Advanced co-morbidity
- History of bleeding diathesis
- Patient refusing the procedure
- Chronic opioid or analgesic use
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- Patients who will operate under emergency conditions
- Block injection site infection
- Known allergy to local anesthetics
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
About this study
Official title: Postoperative Analgesic Efficacy of Rectointercostal Nerve Block in Patients Undergoing Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy is a frequently performed surgery and the gold standard for the treatment of symptomatic gallstone disease. Although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. Poorly controlled early postoperative pain impairs recovery quality and increases the risk of postoperative pulmonary complications, serving as a risk factor for chronic pain development.
Multimodal analgesia, including opioids, is used to manage pain following laparoscopic cholecystectomy. However, opioid treatment may lead to side effects such as postoperative nausea and vomiting (PONV), respiratory depression, and constipation.
The primary aim of this study is to evaluate the effect of recto-intercostal nerve block as part of multimodal analgesia on intraoperative opioid consumption and postoperative pain scores in patients undergoing laparoscopic cholecystectomy.
- Being tested
- The group without the rectointercostal nerve block, The rectointercostal plane block
- Keywords
- Remifantanile conception, Acute pain, Postoperatif pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group without the rectointercostal nerve blockProcedure or surgery
Patients in this group will be administered dexketoprofen 50 mg and tramadol 1 mg/kg intravenously in the intraoperative period. These patients will not receive the rectointercostal nerve block.
The rectointercostal plane blockProcedure or surgery
The rectointercostal plane block is performed under ultrasound guidance after anesthesia induction, before the surgical procedure and with the patient in the supine position. Additionally, patients in this group will be administered dexketoprofen 50 mg and tramadol 1 mg/kg intravenously in the intraoperative period.
| Study group | Role | What they receive |
|---|---|---|
| The group without rectointercostal nerve block | Active comparator | Patients in this group will be administered dexketoprofen 50 mg and tramadol 1 mg/kg intravenously in the intraoperative period. These patients will not receive the rectointercostal nerve block. Receives: Procedure: The group without the rectointercostal nerve block |
| Postoperative analgesic efficacy of rectointercostal nerve block | Active comparator | The patient lies in the supine position. The skin is disinfected. A high-frequency linear probe (6-13 MHz) is placed lateral to the xiphoid to visualize the rectus abdominis muscle at the level of the 7th rib. Using an in-plane technique, a 22G, 50-80 mm block needle is inserted in a cranial direction into the interfascial plane immediately inferolateral to the xiphoid, between the rectus abdominis muscle and the 6th-7th costal cartilages. A total of 20 ml of local anesthetic solution is injected bilaterally (40 ml of 0.25% bupivacaine (marcaine)). The spread of the local anesthetic is confirmed by ultrasound guidance.
Additionally, patients in this group will be administered dexketoprofen 50 mg and tramadol 1 mg/kg intravenously in the intraoperative period. Receives: Procedure: The rectointercostal plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded
Measured: During the intraoperative period
Secondary outcomes (4)
Pain scores
Pain will be assessed at rest and while movement using the from 0 (no pain) to 10 (worst)
Measured: First 24 hours after surgery
Side Effect
Incidence of postoperative nausea and vomiting (PONV) during the postoperative period will be recorded
Measured: Up to the postoperative 24th hours.
Postoperative analgesic consumption
Total postoperative analgesic consumption will be recorded.
Measured: Up to the postoperative 24th hours.
Patient satisfaction
Patient satisfaction was evaluated using a 5-point Likert satisfaction scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied)
Measured: At the postoperative 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start22 Jun 2025
- Primary completion16 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoskopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muruvvet Taskir Turan, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003698
- Sponsor's protocol ID
- AEŞH-EK-2025-009
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2025
- Last updated
- 21 Oct 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Rectointercostal Nerve Block in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07003698
- Acronym / sponsor ID
- AEŞH-EK-2025-009
- Keywords
- Remifantanile conception, Acute pain, Postoperatif pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 4 Jun 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.
Laparoscopic cholecystectomy is a frequently performed surgery and the gold standard for the treatment of symptomatic gallstone disease. Although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. Poorly controlled early postoperative pain impairs recovery quality and increases the risk of postoperative pulmonary complications, serving as a risk factor for chronic pain development.
Multimodal analgesia, including opioids, is used to manage pain following laparoscopic cholecystectomy. However, opioid treatment may lead to side effects such as postoperative nausea and vomiting (PONV), respiratory depression, and constipation.
The primary aim of this study is to evaluate the effect of recto-intercostal nerve block as part of multimodal analgesia on intraoperative opioid consumption and postoperative pain scores in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group without rectointercostal nerve block | Active comparator | Procedure: The group without the rectointercostal nerve blockPatients in this group will be administered dexketoprofen 50 mg and tramadol 1 mg/kg intravenously in the intraoperative period. These patients will not receive the rectointercostal nerve block. |
| Postoperative analgesic efficacy of rectointercostal nerve block | Active comparator | Procedure: The rectointercostal plane blockThe patient lies in the supine position. The skin is disinfected. A high-frequency linear probe (6-13 MHz) is placed lateral to the xiphoid to visualize the rectus abdominis muscle at the level of the 7th rib. Using an in-plane technique, a 22G, 50-80 mm block needle is inserted in a cranial direction into the interfascial plane immediately inferolateral to the xiphoid, between the rectus abdominis muscle and the 6th-7th costal cartilages. A total of 20 ml of local anesthetic solution is injected bilaterally (40 ml of 0.25% bupivacaine (marcaine)). The spread of the local anesthetic is confirmed by ultrasound guidance. Additionally, patients in this group will be administered dexketoprofen 50 mg and tramadol 1 mg/kg intravenously in the intraoperative period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Elective laparoscopic cholecystectomy surgery
Key exclusion criteria (10 listed)
- Under 18 and over 65 years old
- ASA score IV and above
- Advanced co-morbidity
- History of bleeding diathesis
- Patient refusing the procedure
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 |
|---|---|---|
| The group without the rectointercostal nerve blockPatients in this group will be administered dexketoprofen 50 mg and tramadol 1 mg/kg intravenously in the intraoperative period. These patients will not receive the rectointercostal nerve block. | Procedure or surgery | The group without rectointercostal nerve block |
| The rectointercostal plane blockThe rectointercostal plane block is performed under ultrasound guidance after anesthesia induction, before the surgical procedure and with the patient in the supine position. Additionally, patients in this group will be administered dexketoprofen 50 mg and tramadol 1 mg/kg intravenously in the intraoperative period. | Procedure or surgery | Postoperative analgesic efficacy of rectointercostal nerve block |
Primary outcome
Intraoperative remifentanil consumption
Time frame: During the intraoperative period
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded
4 secondary outcomes
Pain scores
Time frame: First 24 hours after surgery
Side Effect
Time frame: Up to the postoperative 24th hours.
Postoperative analgesic consumption
Time frame: Up to the postoperative 24th hours.
Patient satisfaction
Time frame: At the postoperative 24th hours
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 21 Oct 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?
A study testing The group without the rectointercostal nerve block and The rectointercostal plane block in people with Laparoskopic Cholecystectomy and Recto Intercostal Nerve Block, run by Ankara Etlik City 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 3 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 21 Oct 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?
Intraoperative remifentanil consumption (time frame: During the intraoperative period). 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 21 Oct 2026.