Pain, PostoperativeNCT07253610
Effect of Bilateral Rectointercostal Fascial Plane Block on Postoperative Pain After Laparoscopic Sleeve Gastrectomy
A study testing Bilateral Rectointercostal Fascial Plane Block in people with Pain, Postoperative and Obesity, Morbid, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effectiveness of the bilateral rectointercostal fascial plane (RIB) block for postoperative pain management in patients undergoing laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Obesity, Morbid, Laparoscopic Sleeve Gastrectomy (LSG)
- What is being tested?
- Bilateral Rectointercostal Fascial Plane Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 21 Dec 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Body mass index (BMI) > 35 kg/m²
- American Society of Anesthesiologists (ASA) physical status II-III
- Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia
- Provided written informed consent to participate in the study
Who cannot join
- Chronic opioid use or dependence
- History of chronic pain
- Known allergy or contraindication to local anesthetics or opioids
- Severe cardiac, hepatic, or renal disease
- Severe psychiatric disorder (e.g., psychosis, dementia)
- STOP-BANG score ≥ 5 (high risk for obstructive sleep apnea)
- Block failure or incomplete block after local anesthetic injection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University Faculty of Medicine, Medical Park Gaziosmanpasa Hospital
Istanbul
About this study
Official title: Investigation of the Effects of Bilateral Rectointercostal Fascial Plane Block on Postoperative Acute Pain in Patients Undergoing Laparoscopic Sleeve Gastrectomy
This randomized controlled study aims to evaluate the effectiveness of the bilateral rectointercostal fascial plane (RIB) block for postoperative pain management in patients undergoing laparoscopic sleeve gastrectomy. The study compares RIB block combined with standard general anesthesia to standard intravenous patient-controlled analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours, while secondary outcomes include pain scores, patient satisfaction, postoperative nausea and vomiting, and block-related complications.
Read the detailed description
Adequate pain relief in the postoperative period is a crucial determinant of patient comfort, early mobilization, and overall recovery after laparoscopic sleeve gastrectomy. Effective analgesia not only enhances patient satisfaction but also reduces postoperative complications, facilitates respiratory function, and shortens hospital stay. Conversely, inadequate pain control may lead to delayed mobilization, nausea, vomiting, increased opioid requirements, and prolonged recovery.
In recent years, regional anesthesia techniques, particularly abdominal wall and fascial plane blocks, have become an integral part of multimodal analgesia strategies designed to reduce opioid consumption and minimize related adverse effects. The rectointercostal fascial plane (RIB) block, first described by Tulgar et al. in 2023, is a novel regional technique that targets the thoracoabdominal intercostal nerves by injecting local anesthetic between the rectus abdominis and intercostal muscles at the level of the costal cartilage. This block has shown promising results in providing effective postoperative analgesia after upper abdominal laparoscopic surgeries.
The present randomized controlled study was designed to evaluate the effectiveness of the bilateral rectointercostal fascial plane block compared with standard intravenous patient-controlled analgesia in patients undergoing laparoscopic sleeve gastrectomy. The primary outcome is total opioid consumption during the first 24 postoperative hours, and the secondary outcomes include pain scores at rest and during movement, patient satisfaction, incidence of postoperative nausea and vomiting, and block-related complications.
- Being tested
- Bilateral Rectointercostal Fascial Plane Block, Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine
- Keywords
- Rectointercostal Fascial Plane Block, Laparoscopic Sleeve Gastrectomy, Morbid Obesity, Opioid Consumption
- Medical subject headings
- Pain, Postoperative, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Rectointercostal Fascial Plane BlockOther
Under ultrasound guidance, 30 mL of local anesthetic will be injected bilaterally between the rectus abdominis and intercostal muscles at the level of the 6th-7th costal cartilages to achieve rectointercostal fascial plane block prior to general anesthesia.
Intravenous Patient-Controlled Analgesia (IV PCA) with MorphineOther
For all groups, intravenous patient-controlled analgesia (IV PCA) will be initiated in the post-anesthesia care unit (PACU) using a BodyGuard 575 Pain Manager (UK). The total morphine consumption during the first 24 hours postoperatively will be recorded. The PCA regimen will be standardized as follows: no basal infusion, a 1 mg morphine bolus dose, a lock-out interval of 15 minutes, and a maximum dose limit of 10 mg within 4 hours.
Approximately 45 minutes before the end of surgery, patients will receive 1 g paracetamol, 20 mg tenoxicam, and 3.5 mg morphine intravenously. Postoperatively, paracetamol will be administered every 8 hours and tenoxicam every 12 hours. This postoperative pain management strategy reflects the standard protocol routinely used in our clinic.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Rectointercostal Fascial Plane Block Group | Experimental | Participants in this group will receive bilateral rectointercostal fascial plane (RIB) block under ultrasound guidance prior to induction of general anesthesia. Following surgery, standard intravenous patient-controlled analgesia (PCA) with morphine will be administered. Receives: Other: Bilateral Rectointercostal Fascial Plane Block; Other: Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine |
| Control Group (General Anesthesia + PCA) | Active comparator | Participants in this group will receive only general anesthesia followed by standard intravenous patient-controlled analgesia (PCA) with morphine. No fascial plane block will be performed. Receives: Other: Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Opioid Consumption in the First 24 Hours After Surgery
The primary outcome is defined as the total cumulative opioid consumption during the first 24 hours after surgery. Opioid use will be recorded as the total amount of morphine administered via intravenous patient-controlled analgesia (PCA). Patients will be instructed to request analgesia through the PCA device whenever their numeric rating scale (NRS) pain score is ≥4. No basal infusion will be used
Measured: Postoperative day 1 (0-24 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 posted28 Nov 2025
- Study start1 Nov 2025
- Primary completion21 Dec 2025
- Study completion21 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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 prospective, randomized, double-blind, parallel-group study involving two arms. The RIB group will receive bilateral rectointercostal fascial plane block in addition to standard general anesthesia and intravenous patient-controlled analgesia (PCA), while the control group will receive only general anesthesia and PCA.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253610
- Sponsor's protocol ID
- Istinye Univesitesi HREC
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be shared because the dataset includes sensitive clinical and perioperative information, and institutional data protection policies do not allow the external release of participant-level data.
Publications
Bayram E, Bilal B, Kahyaoglu S, Seyit H, Altundal YE, Tulgar S, Cicek M. Evaluation of the analgesic efficacy of ultrasound-guided bilateral high-volume recto-intercostal plane block in laparoscopic sleeve gastrectomy: a prospective randomized controlled trial. BMC Anesthesiol. 2026 May 11;26(1):397. doi: 10.1186/s12871-026-03856-2.
PubMed 42115952
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Bilateral Rectointercostal Fascial Plane Block on Postoperative Acute Pain in Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT07253610
- Acronym / sponsor ID
- Istinye Univesitesi HREC
- Keywords
- Rectointercostal Fascial Plane Block, Laparoscopic Sleeve Gastrectomy, Morbid Obesity, Opioid Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 21 Dec 2025 (actual)
- Study completion
- 21 Dec 2025 (actual)
- First posted
- 28 Nov 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 study aims to evaluate the effectiveness of the bilateral rectointercostal fascial plane (RIB) block for postoperative pain management in patients undergoing laparoscopic sleeve gastrectomy. The study compares RIB block combined with standard general anesthesia to standard intravenous patient-controlled analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours, while secondary outcomes include pain scores, patient satisfaction, postoperative nausea and vomiting, and block-related complications.
Detailed description
Adequate pain relief in the postoperative period is a crucial determinant of patient comfort, early mobilization, and overall recovery after laparoscopic sleeve gastrectomy. Effective analgesia not only enhances patient satisfaction but also reduces postoperative complications, facilitates respiratory function, and shortens hospital stay. Conversely, inadequate pain control may lead to delayed mobilization, nausea, vomiting, increased opioid requirements, and prolonged recovery.
In recent years, regional anesthesia techniques, particularly abdominal wall and fascial plane blocks, have become an integral part of multimodal analgesia strategies designed to reduce opioid consumption and minimize related adverse effects. The rectointercostal fascial plane (RIB) block, first described by Tulgar et al. in 2023, is a novel regional technique that targets the thoracoabdominal intercostal nerves by injecting local anesthetic between the rectus abdominis and intercostal muscles at the level of the costal cartilage. This block has shown promising results in providing effective postoperative analgesia after upper abdominal laparoscopic surgeries.
The present randomized controlled study was designed to evaluate the effectiveness of the bilateral rectointercostal fascial plane block compared with standard intravenous patient-controlled analgesia in patients undergoing laparoscopic sleeve gastrectomy. The primary outcome is total opioid consumption during the first 24 postoperative hours, and the secondary outcomes include pain scores at rest and during movement, patient satisfaction, incidence of postoperative nausea and vomiting, and block-related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, double-blind, parallel-group study involving two arms. The RIB group will receive bilateral rectointercostal fascial plane block in addition to standard general anesthesia and intravenous patient-controlled analgesia (PCA), while the control group will receive only general anesthesia and PCA.
| Arm | Type | Receives |
|---|---|---|
| Bilateral Rectointercostal Fascial Plane Block Group | Experimental | Other: Bilateral Rectointercostal Fascial Plane Block, Other: Intravenous Patient-Controlled Analgesia (IV PCA) with MorphineParticipants in this group will receive bilateral rectointercostal fascial plane (RIB) block under ultrasound guidance prior to induction of general anesthesia. Following surgery, standard intravenous patient-controlled analgesia (PCA) with morphine will be administered. |
| Control Group (General Anesthesia + PCA) | Active comparator | Other: Intravenous Patient-Controlled Analgesia (IV PCA) with MorphineParticipants in this group will receive only general anesthesia followed by standard intravenous patient-controlled analgesia (PCA) with morphine. No fascial plane block will be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Body mass index (BMI) > 35 kg/m²
- American Society of Anesthesiologists (ASA) physical status II-III
- Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia
- Provided written informed consent to participate in the study
Key exclusion criteria (7 listed)
- Chronic opioid use or dependence
- History of chronic pain
- Known allergy or contraindication to local anesthetics or opioids
- Severe cardiac, hepatic, or renal disease
- Severe psychiatric disorder (e.g., psychosis, dementia)
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 Rectointercostal Fascial Plane BlockUnder ultrasound guidance, 30 mL of local anesthetic will be injected bilaterally between the rectus abdominis and intercostal muscles at the level of the 6th-7th costal cartilages to achieve rectointercostal fascial plane block prior to general anesthesia. | Other | Bilateral Rectointercostal Fascial Plane Block Group |
| Intravenous Patient-Controlled Analgesia (IV PCA) with MorphineFor all groups, intravenous patient-controlled analgesia (IV PCA) will be initiated in the post-anesthesia care unit (PACU) using a BodyGuard 575 Pain Manager (UK). The total morphine consumption during the first 24 hours postoperatively will be recorded. The PCA regimen will be standardized as follows: no basal infusion, a 1 mg morphine bolus dose, a lock-out interval of 15 minutes, and a maximum dose limit of 10 mg within 4 hours. Approximately 45 minutes before the end of surgery, patients will receive 1 g paracetamol, 20 mg tenoxicam, and 3.5 mg morphine intravenously. Postoperatively, paracetamol will be administered every 8 hours and tenoxicam every 12 hours. This postoperative pain management strategy reflects the standard protocol routinely used in our clinic. | Other | Bilateral Rectointercostal Fascial Plane Block Group, Control Group (General Anesthesia + PCA) |
Primary outcome
Cumulative Opioid Consumption in the First 24 Hours After Surgery
Time frame: Postoperative day 1 (0-24 hours after surgery)
The primary outcome is defined as the total cumulative opioid consumption during the first 24 hours after surgery. Opioid use will be recorded as the total amount of morphine administered via intravenous patient-controlled analgesia (PCA). Patients will be instructed to request analgesia through the PCA device whenever their numeric rating scale (NRS) pain score is ≥4. No basal infusion will be used
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 29 Dec 2025.
- Derived from this study: PubMed 42115952Bayram E, Bilal B, Kahyaoglu S, Seyit H, Altundal YE, Tulgar S, Cicek M. Evaluation of the analgesic efficacy of ultrasound-guided bilateral high-volume recto-intercostal plane block in laparoscopic sleeve gastrectomy: a prospective randomized controlled trial. BMC Anesthesiol. 2026 May 11;26(1):397. doi: 10.1186/s12871-026-03856-2.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be shared because the dataset includes sensitive clinical and perioperative information, and institutional data protection policies do not allow the external release of participant-level data.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 Bilateral Rectointercostal Fascial Plane Block in people with Pain, Postoperative and Obesity, Morbid, run by Samsun University 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 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 29 Dec 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?
Cumulative Opioid Consumption in the First 24 Hours After Surgery (time frame: Postoperative day 1 (0-24 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 NCT07253610, which also lists 1 linked publication.
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 29 Dec 2025.