Postoperative PainRSB-MIDLINENCT07393763
Rectus Sheath Block as an Adjunct to General Anesthesia for Midline Laparotomy Pain
A study testing Ultrasound-guided rectus sheath block in people with Postoperative Pain and Abdominal Surgery by Laparotomy, run by Udayana University at 1 site in Indonesia.
Trial summary
This study evaluates whether adding an ultrasound-guided rectus sheath block (RSB) to general anesthesia can improve pain control after midline laparotomy. Adult patients undergoing midline incision laparotomy will be randomly assigned to receive either general anesthesia alone or general anesthesia plus bilateral RSB… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Postoperative Pain, Abdominal Surgery by Laparotomy
- What is being tested?
- Ultrasound-guided rectus sheath block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2022to 30 Apr 2022
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-64 years.
- Patients undergoing midline laparotomy incision (incision extending above to below the umbilicus) for digestive, obstetric, or oncology cases (corresponding to T7-T12 dermatomes) under general anesthesia.
- ASA physical status I-III.
- Body mass index (BMI) 18.5-30 kg/m².
- Willing and able to provide written informed consent.
Who cannot join
- Refusal to participate.
- Infection or wound at the planned block site.
- Decreased level of consciousness.
- Known allergy to local anesthetics or opioids.
- Coagulation disorder.
- History of chronic pain.
- Hyperalgesia.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Ngoerah Hospital, Denpasar, Bali, Indonesia
Denpasar, Bali, 80111
About this study
Official title: Effectiveness of Rectus Sheath Block as an Adjunct to General Anesthesia for Postoperative Pain and Inflammation in Patients Undergoing Midline Incision Laparotomy at RSUP Sanglah
This study evaluates whether adding an ultrasound-guided rectus sheath block (RSB) to general anesthesia can improve pain control after midline laparotomy. Adult patients undergoing midline incision laparotomy will be randomly assigned to receive either general anesthesia alone or general anesthesia plus bilateral RSB with local anesthetic (bupivacaine 0.25%). After surgery, pain will be assessed using the Numeric Rating Scale (NRS) at 15 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours. The study will also compare the time to first opioid request, total opioid use during the first 24 hours after surgery, and changes in inflammation measured by the neutrophil-to-lymphocyte ratio (NLR). The goal is to determine whether RSB can reduce postoperative pain and opioid requirements and help limit postoperative inflammatory response.
Read the detailed description
This is a double-blind randomized controlled trial conducted in adult patients (18-64 years) undergoing midline incision laparotomy under general anesthesia at Sanglah Hospital. Eligible participants are enrolled consecutively and randomized using permuted block randomization with sealed envelopes into two parallel groups:
Group A (Control): General anesthesia without rectus sheath block.
Group B (Intervention): General anesthesia plus bilateral ultrasound-guided posterior rectus sheath block (RSB) using bupivacaine 0.25%.
Anesthetic management is standardized. Patients receive IV midazolam 0.02 mg/kg as premedication. Induction is performed with propofol 1-2 mg/kg and fentanyl 2 mcg/kg, followed by atracurium 0.5 mg/kg for intubation. Maintenance includes pressure-controlled ventilation (FiO₂ 40%, flow 2 L/min) and propofol infusion 50-150 mcg/kg/min. Intraoperative analgesia is supplemented with fentanyl 0.5 mcg/kg every 45 minutes. Hemodynamics are maintained within 20% of baseline.
RSB technique (Group B): After intubation, the abdominal skin is disinfected. A linear ultrasound probe is placed lateral to the umbilicus to identify the rectus abdominis muscle and posterior rectus sheath. Using an in-plane approach, a 50 mm needle is advanced from lateral to medial until the needle tip lies between the rectus abdominis muscle and posterior rectus sheath. After negative aspiration, 20 mL of bupivacaine 0.25% is injected as a single-shot on one side with aspiration every 3 mL, visualizing separation of the rectus muscle from the posterior sheath. The procedure is then repeated on the contralateral side (bilateral block).
Postoperative management and assessments: Pain is evaluated by an independent observer using the Numeric Rating Scale (NRS 0-10) at T1 (15 minutes in the recovery room), T2 (1 hour), T3 (3 hours), T4 (6 hours), T5 (12 hours), and T6 (24 hours) postoperatively. Postoperative analgesia includes patient-controlled analgesia (PCA) morphine demand-only (1 mg per demand dose) for patients with GCS 15, plus oral paracetamol 500 mg every 6 hours. The time to first opioid request is recorded (minutes), and total morphine consumption during the first 24 hours is collected.
Inflammation assessment: Neutrophil-to-lymphocyte ratio (NLR) is measured from complete blood count (CBC) preoperatively (one day before surgery) and postoperatively (in the recovery room).
Key outcomes include postoperative NRS scores (T1-T6), time to first opioid request, total opioid requirement in the first 24 hours, and perioperative changes in NLR.
- Being tested
- Ultrasound-guided rectus sheath block
- Keywords
- Rectus Sheath Block, Midline Laparotomy, Ultrasound-Guided, Opioid Consumption, Numeric Rating Scale, Neutrophil-to-Lymphocyte Ratio, 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.
Ultrasound-guided rectus sheath blockProcedure or surgery
Bilateral posterior rectus sheath block performed under ultrasound guidance after induction of general anesthesia. Single-shot injection of bupivacaine 0.25% (20 mL per side) between the rectus abdominis muscle and posterior rectus sheath.
| Study group | Role | What they receive |
|---|---|---|
| Control: General Anesthesia Only | No intervention | Participants receive standard general anesthesia without rectus sheath block. Postoperative analgesia follows institutional protocol (e.g., PCA morphine and paracetamol). |
| Intervention: General Anesthesia + Bilateral Rectus Sheath Block | Experimental | Participants receive standard general anesthesia plus bilateral ultrasound-guided posterior rectus sheath block (single-shot) using bupivacaine 0.25%, 20 mL per side, performed after induction of anesthesia. Receives: Procedure: Ultrasound-guided rectus sheath block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity (Numeric Rating Scale, NRS)
Pain intensity measured using the Numeric Rating Scale (0-10; 0 = no pain, 10 = worst imaginable pain) by a blinded assessor.
Measured: 15 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after surgery
Secondary outcomes (4)
Time to First Opioid Request
Time from arrival in recovery room to first request for opioid analgesia (minutes).
Measured: Up to 24 hours after surgery
Total Opioid Consumption
Total morphine consumption recorded from PCA during the first 24 hours after surgery (mg)
Measured: 24 hours after surgery
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
NLR calculated from complete blood count measured preoperatively and postoperatively in the recovery room.
Measured: Preoperative (1 day before surgery) and postoperative (in recovery room)
Postoperative Nausea and Vomiting (PONV
Incidence of nausea/vomiting within 24 hours postoperatively.
Measured: Up to 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 posted6 Feb 2026
- Study start1 Feb 2022
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
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
- Two-arm parallel-group randomized trial comparing general anesthesia alone versus general anesthesia plus bilateral ultrasound-guided rectus sheath block.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Collaborators
- RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Responsible party
- Principal investigator, Prema Putra, Udayana University
- Investigators
- I Made Prema Putra, Principal investigator, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393763
- Sponsor's protocol ID
- 2022.02.1.0341
- Other IDs
- 2022.02.1.0341, EC-UNUD-82.0-2022
- Acronym
- RSB-MIDLINE
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will not be shared publicly. Data may be considered for sharing upon reasonable request to the principal investigator, subject to institutional and ethics approval
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Rectus Sheath Block as an Adjunct to General Anesthesia for Postoperative Pain and Inflammation in Patients Undergoing Midline Incision Laparotomy at RSUP Sanglah
- ClinicalTrials.gov ID
- NCT07393763
- Acronym / sponsor ID
- RSB-MIDLINE / 2022.02.1.0341
- Keywords
- Rectus Sheath Block, Midline Laparotomy, Ultrasound-Guided, Opioid Consumption, Numeric Rating Scale, Neutrophil-to-Lymphocyte Ratio, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Collaborators
- RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 6 Feb 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 study evaluates whether adding an ultrasound-guided rectus sheath block (RSB) to general anesthesia can improve pain control after midline laparotomy. Adult patients undergoing midline incision laparotomy will be randomly assigned to receive either general anesthesia alone or general anesthesia plus bilateral RSB with local anesthetic (bupivacaine 0.25%). After surgery, pain will be assessed using the Numeric Rating Scale (NRS) at 15 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours. The study will also compare the time to first opioid request, total opioid use during the first 24 hours after surgery, and changes in inflammation measured by the neutrophil-to-lymphocyte ratio (NLR). The goal is to determine whether RSB can reduce postoperative pain and opioid requirements and help limit postoperative inflammatory response.
Detailed description
This is a double-blind randomized controlled trial conducted in adult patients (18-64 years) undergoing midline incision laparotomy under general anesthesia at Sanglah Hospital. Eligible participants are enrolled consecutively and randomized using permuted block randomization with sealed envelopes into two parallel groups:
Group A (Control): General anesthesia without rectus sheath block.
Group B (Intervention): General anesthesia plus bilateral ultrasound-guided posterior rectus sheath block (RSB) using bupivacaine 0.25%.
Anesthetic management is standardized. Patients receive IV midazolam 0.02 mg/kg as premedication. Induction is performed with propofol 1-2 mg/kg and fentanyl 2 mcg/kg, followed by atracurium 0.5 mg/kg for intubation. Maintenance includes pressure-controlled ventilation (FiO₂ 40%, flow 2 L/min) and propofol infusion 50-150 mcg/kg/min. Intraoperative analgesia is supplemented with fentanyl 0.5 mcg/kg every 45 minutes. Hemodynamics are maintained within 20% of baseline.
RSB technique (Group B): After intubation, the abdominal skin is disinfected. A linear ultrasound probe is placed lateral to the umbilicus to identify the rectus abdominis muscle and posterior rectus sheath. Using an in-plane approach, a 50 mm needle is advanced from lateral to medial until the needle tip lies between the rectus abdominis muscle and posterior rectus sheath. After negative aspiration, 20 mL of bupivacaine 0.25% is injected as a single-shot on one side with aspiration every 3 mL, visualizing separation of the rectus muscle from the posterior sheath. The procedure is then repeated on the contralateral side (bilateral block).
Postoperative management and assessments: Pain is evaluated by an independent observer using the Numeric Rating Scale (NRS 0-10) at T1 (15 minutes in the recovery room), T2 (1 hour), T3 (3 hours), T4 (6 hours), T5 (12 hours), and T6 (24 hours) postoperatively. Postoperative analgesia includes patient-controlled analgesia (PCA) morphine demand-only (1 mg per demand dose) for patients with GCS 15, plus oral paracetamol 500 mg every 6 hours. The time to first opioid request is recorded (minutes), and total morphine consumption during the first 24 hours is collected.
Inflammation assessment: Neutrophil-to-lymphocyte ratio (NLR) is measured from complete blood count (CBC) preoperatively (one day before surgery) and postoperatively (in the recovery room).
Key outcomes include postoperative NRS scores (T1-T6), time to first opioid request, total opioid requirement in the first 24 hours, and perioperative changes in NLR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel-group randomized trial comparing general anesthesia alone versus general anesthesia plus bilateral ultrasound-guided rectus sheath block.
| Arm | Type | Receives |
|---|---|---|
| Control: General Anesthesia Only | No intervention | –Participants receive standard general anesthesia without rectus sheath block. Postoperative analgesia follows institutional protocol (e.g., PCA morphine and paracetamol). |
| Intervention: General Anesthesia + Bilateral Rectus Sheath Block | Experimental | Procedure: Ultrasound-guided rectus sheath blockParticipants receive standard general anesthesia plus bilateral ultrasound-guided posterior rectus sheath block (single-shot) using bupivacaine 0.25%, 20 mL per side, performed after induction of anesthesia. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-64 years.
- Patients undergoing midline laparotomy incision (incision extending above to below the umbilicus) for digestive, obstetric, or oncology cases (corresponding to T7-T12 dermatomes) under general anesthesia.
- ASA physical status I-III.
- Body mass index (BMI) 18.5-30 kg/m².
- Willing and able to provide written informed consent.
Key exclusion criteria (7 listed)
- Refusal to participate.
- Infection or wound at the planned block site.
- Decreased level of consciousness.
- Known allergy to local anesthetics or opioids.
- Coagulation disorder.
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 |
|---|---|---|
| Ultrasound-guided rectus sheath blockBilateral posterior rectus sheath block performed under ultrasound guidance after induction of general anesthesia. Single-shot injection of bupivacaine 0.25% (20 mL per side) between the rectus abdominis muscle and posterior rectus sheath. | Procedure or surgery | Intervention: General Anesthesia + Bilateral Rectus Sheath Block |
Primary outcome
Postoperative Pain Intensity (Numeric Rating Scale, NRS)
Time frame: 15 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after surgery
Pain intensity measured using the Numeric Rating Scale (0-10; 0 = no pain, 10 = worst imaginable pain) by a blinded assessor.
4 secondary outcomes
Time to First Opioid Request
Time frame: Up to 24 hours after surgery
Total Opioid Consumption
Time frame: 24 hours after surgery
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Preoperative (1 day before surgery) and postoperative (in recovery room)
Postoperative Nausea and Vomiting (PONV
Time frame: Up to 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 6 Feb 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will not be shared publicly. Data may be considered for sharing upon reasonable request to the principal investigator, subject to institutional and ethics approval
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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.
I Made Prema Putra principal investigator
Udayana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided rectus sheath block in people with Postoperative Pain and Abdominal Surgery by Laparotomy, run by Udayana University at 1 site in Indonesia.
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 6 Feb 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 Indonesia. 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 (Numeric Rating Scale, NRS) (time frame: 15 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 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 6 Feb 2026.