Pain ManagementNCT07384000
Comparison Between External Oblique Intercostal Plane Block and Rectus Sheath Block Combined With Transversus Abdominis Plane Block
A study testing External intercostal plane puncture and the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block) in people with Pain Management and Anesthesia , Analgesia, run by Minia University.
Trial summary
Effective perioperative pain management remains a cornerstone in enhancing recovery and improving patient outcomes in laparoscopic cholecystectomy. This minimally invasive procedure, although less traumatic compared to open surgery, can still lead to significant postoperative pain, particularly in the early hours… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Anesthesia , Analgesia, Nerve Block
- What is being tested?
- External intercostal plane puncture and the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) 1-II
- aged 18-70 years
- both genders will be included.
- body mass index (BMI) ≤ 35 kg/m2.
Who cannot join
- coagulation disorders
- liver/kidney disease
- History of abdominal surgery
- infection in the block application area
- chronic opioid use
- local anesthetic (LA) allergy
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Menna Tallah Mamdouh Lecturer, Lecturer contact
About this study
Official title: The Efficacy of Single Puncture Technique of Rectus Sheath Block Combined With Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Pain Control After Laparoscopic Cholecystectomy.
Effective perioperative pain management remains a cornerstone in enhancing recovery and improving patient outcomes in laparoscopic cholecystectomy. This minimally invasive procedure, although less traumatic compared to open surgery, can still lead to significant postoperative pain, particularly in the early hours following the operation. Insufficient pain control may result in delayed mobilization, prolonged hospital stays, and increased opioid consumption, which are associated with adverse side effects and a heightened risk of complications . Regional anesthesia techniques have garnered significant attention for their ability to provide localized, opioid-sparing analgesia, thereby improving postoperative recovery profiles.External Oblique Intercostal Plane Block (EOIP) is a relatively new regional anesthesia technique targeting the intercostal nerves (T7-T11) as they traverse the plane between the external and internal oblique muscles. This block has demonstrated efficacy in controlling postoperative pain for upper abdominal surgeries, including laparoscopic cholecystectomy. By selectively anesthetizing the sensory branches of the thoracoabdominal nerves, the EOIP block provides localized analgesia with minimal motor blockade, making it an ideal choice for early mobilization (Ouchi et al., 2020).Recent advancements in ultrasound-guided techniques have improved the precision and safety of the EOIP block, allowing for consistent blockade of the targeted nerves. Clinical trials have highlighted its ability to reduce the pain significantly in the first 24 hours postoperatively, along with a marked decrease in the need for rescue analgesics. Tranrversus abdominis plane block (TAP) , first described in the early 2000s, has undergone several modifications to improve its efficacy in abdominal surgeries. The subcostal TAP block targets the anterior branches of the lower thoracic nerves (T6-T9) to provide analgesia to the upper abdominal wall. This technique is particularly suited for laparoscopic cholecystectomy, where the pain originates predominantly from the pari0etal peritoneum and abdominal wall incisions.The single puncture technique of Rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) represents a more streamlined approach to abdominal wall analgesia. ultrasonography (US) guidance for peripheral nerve blocks has become more and more popular. Transversus abdominis plane block (TAPB) and US-guided rectus sheath block (RSB) have been utilized in abdominal surgeries and have shown strong analgesic effects. Prior researches has demonstrated that in abdominal surgery, US-guided (TAPB) in conjunction with (RSB) had superior analgesic effects than either (TAPB) or (RSB) alone. Currently, multipoint nerve block procedures are generally applied in clinical practice, but they are difficult and can increase the patient's suffering. A novel method is proposed based on the neuromuscular anatomy and the location of the incisiopn in laparoscopic upper abdominal surgery: US-guided transverse abdominis plane and rectus sheath block one-puncture .
Read the detailed description
This study aims to investigate the analgesic efficacy of external oblique intercostal plane (EOIPB) versus single puncture technique of rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) after laparoscopic cholecystectomy.
Primary Outcome:
The primary outcome of the study will be the amount of opoid (nalbuphine) consumption in the first 24 hours postoperatively.
Secondary Outcomes:
the analgesic efficacy (Sensory assessment) by defined dermal zones in the first 24 hours postoperatively.
pain intensity at rest and during coughing using verbal rating scale in the first 24 hours postoperatively.
Patient satisfaction in the first 24 hours postoperatively. The hemodynamic changes. Time to first rescue analgesia. First off-bed activity Incidence of block-related complications. Signs of local anesthetic toxicity hypotension ,bradycardia ,tachyarrhythmia, postoperative nausea and vomiting (PONV) and dizziness.
- Conditions
- Pain Management, Anesthesia , Analgesia, Nerve Block
- Being tested
- External intercostal plane puncture, control group (nalbuphine), the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block)
- Keywords
- Comparison Between External Oblique Intercostal Plane Block and Rectus Sheath Block Combined With Transversus Abdominis Plane Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External intercostal plane punctureProcedure or surgery
Patients in this group will receive external intercostal plane block bilaterally, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine injected into the external oblique intercostal plane on each side.
control group (nalbuphine)Drug
Patients in this group will not receive any intervention or nerve block.
the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block)Procedure or surgery
Patients in this group will receive rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) bilaterally via single puncture, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine divided into 10 ml of 0.25% bupivacaine will be injected when the needle reaches the posterior rectus abdominis sheath and pierces the anterior layer of the posterior sheath, Then, the needle will break through the posterior layer of the tendon to the transversus abdominis plane and another 10 ml of 0.25% bupivacaine will be injected into transversus abdominis plane .
| Study group | Role | What they receive |
|---|---|---|
| external intercostal plane block intervention with ultra sound | Active comparator | Patients in this group will receive (EOIPB) bilaterally, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine injected into the external oblique intercostal plane on each side. Receives: Procedure: External intercostal plane puncture |
| single-puncture technique of (RSB) combined with (TAPB) by ultra sound | Active comparator | Patients in this group will receive rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) bilaterally via single puncture, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine divided into 10 ml of 0.25% bupivacaine will be injected when the needle reaches the posterior rectus abdominis sheath and pierces the anterior layer of the posterior sheath, Then, the needle will break through the posterior layer of the tendon to the transversus abdominis plane and another 10 ml of 0.25% bupivacaine will be injected into transversus abdominis plane . Receives: Procedure: the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block) |
| control group (nalbuphine) | Placebo comparator | Patients in this group will not receive any intervention or nerve block. Receives: Drug: control group (nalbuphine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrase the consumption of opioids
The primary outcome of the study will be the amount of opoid (nalbuphine) consumption in the first 24 hours postoperatively.
Measured: Intraoperative, immediately postoperative , 2 hours post operative , 4 hours post operative , 6 hours postoperative, 12 hours postoperative, 24 hours postoperative
Secondary outcomes (3)
The analgesic efficacy (sensory assessment)
Sensory assessment by defined dermal zones at 1, 2, 6, 12, and 24 hours postoperatively.
The specific dermal zones will be described by vertical lines at the midline (A), mid-clavicular line (B), anterior axillary line (C), mid-axillary line (D), posterior axillary line (E), infrascapular line (F), and back midline (J).
Four horizontal lines at the xiphoid level (a),12th costal level (b), the umbilical level (c), the anterior superior iliac spine to the pubic symphysis line (d), and extension to the back to the anterior superior iliac spine level (e).
An additional zone will be defined as the upper 1/3 of the front thigh . Sensory assessment will be achieved using 70% ethyl alcohol swab and pinprick at 1,2, 6, 12, and 24 hours postoperatively after extubation at specific dermal zones divided by anatomic landmark lines on the abdomen, the back, and the thigh.
Effective analgesic efficacy was defined as loss of cold temperature sensation to alcohol swab or loss of pinprick pain sensat
Measured: First hour, second hour , sixth hour, 12th hour , 24th hour postoperatively
Pain intensity
pain intensity will be assessed at rest and during coughing using verbal rating scale (Jensen \& Karoly 1992) every hour till 6 hour, then every 2 hours till 12 hours, then every 4 hours till 24 hours. postoperatively as: No pain (=1) , Mild pain(=2)
, Moderate pain(=3) , Sever pain(=4).
Measured: Immediately postoperative, 2 hours postoperative, 4 hours postoperatively, 6 hours postoperative, 12 hours postoperative, 24 hours postoperative
Off bed activity
time of the first off-bed activity after surgery in minutes , comparison between all arms and intervention
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start20 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
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 ManagementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in parallel to one of three groups: (1) external intercostal plane block, or (2) combined rectus sheath block and transversus abdominis plane block by single puncture technique (3) the control group recieve nalbuphine . Each participant receives only one intervention according to group allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Mohamed Hassan, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384000
- Sponsor's protocol ID
- nerve block in pain management
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yu S, Wen Y, Lin J, Yang J, He Y, Zuo Y. Combined rectus sheath block with transverse abdominis plane block by one puncture for analgesia after laparoscopic upper abdominal surgery: a randomized controlled prospective study. BMC Anesthesiol. 2024 Feb 9;24(1):58. doi: 10.1186/s12871-024-02444-6.
PubMed 38336613
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Single Puncture Technique of Rectus Sheath Block Combined With Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Pain Control After Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT07384000
- Acronym / sponsor ID
- nerve block in pain management
- Conditions
- Pain Management, Anesthesia , Analgesia, Nerve Block
- Keywords
- Comparison Between External Oblique Intercostal Plane Block and Rectus Sheath Block Combined With Transversus Abdominis Plane Block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 3 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.
Effective perioperative pain management remains a cornerstone in enhancing recovery and improving patient outcomes in laparoscopic cholecystectomy. This minimally invasive procedure, although less traumatic compared to open surgery, can still lead to significant postoperative pain, particularly in the early hours following the operation. Insufficient pain control may result in delayed mobilization, prolonged hospital stays, and increased opioid consumption, which are associated with adverse side effects and a heightened risk of complications . Regional anesthesia techniques have garnered significant attention for their ability to provide localized, opioid-sparing analgesia, thereby improving postoperative recovery profiles.External Oblique Intercostal Plane Block (EOIP) is a relatively new regional anesthesia technique targeting the intercostal nerves (T7-T11) as they traverse the plane between the external and internal oblique muscles. This block has demonstrated efficacy in controlling postoperative pain for upper abdominal surgeries, including laparoscopic cholecystectomy. By selectively anesthetizing the sensory branches of the thoracoabdominal nerves, the EOIP block provides localized analgesia with minimal motor blockade, making it an ideal choice for early mobilization (Ouchi et al., 2020).Recent advancements in ultrasound-guided techniques have improved the precision and safety of the EOIP block, allowing for consistent blockade of the targeted nerves. Clinical trials have highlighted its ability to reduce the pain significantly in the first 24 hours postoperatively, along with a marked decrease in the need for rescue analgesics. Tranrversus abdominis plane block (TAP) , first described in the early 2000s, has undergone several modifications to improve its efficacy in abdominal surgeries. The subcostal TAP block targets the anterior branches of the lower thoracic nerves (T6-T9) to provide analgesia to the upper abdominal wall. This technique is particularly suited for laparoscopic cholecystectomy, where the pain originates predominantly from the pari0etal peritoneum and abdominal wall incisions.The single puncture technique of Rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) represents a more streamlined approach to abdominal wall analgesia. ultrasonography (US) guidance for peripheral nerve blocks has become more and more popular. Transversus abdominis plane block (TAPB) and US-guided rectus sheath block (RSB) have been utilized in abdominal surgeries and have shown strong analgesic effects. Prior researches has demonstrated that in abdominal surgery, US-guided (TAPB) in conjunction with (RSB) had superior analgesic effects than either (TAPB) or (RSB) alone. Currently, multipoint nerve block procedures are generally applied in clinical practice, but they are difficult and can increase the patient's suffering. A novel method is proposed based on the neuromuscular anatomy and the location of the incisiopn in laparoscopic upper abdominal surgery: US-guided transverse abdominis plane and rectus sheath block one-puncture .
Detailed description
This study aims to investigate the analgesic efficacy of external oblique intercostal plane (EOIPB) versus single puncture technique of rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) after laparoscopic cholecystectomy.
Primary Outcome:
The primary outcome of the study will be the amount of opoid (nalbuphine) consumption in the first 24 hours postoperatively.
Secondary Outcomes:
the analgesic efficacy (Sensory assessment) by defined dermal zones in the first 24 hours postoperatively.
pain intensity at rest and during coughing using verbal rating scale in the first 24 hours postoperatively.
Patient satisfaction in the first 24 hours postoperatively. The hemodynamic changes. Time to first rescue analgesia. First off-bed activity Incidence of block-related complications. Signs of local anesthetic toxicity hypotension ,bradycardia ,tachyarrhythmia, postoperative nausea and vomiting (PONV) and dizziness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in parallel to one of three groups: (1) external intercostal plane block, or (2) combined rectus sheath block and transversus abdominis plane block by single puncture technique (3) the control group recieve nalbuphine . Each participant receives only one intervention according to group allocation.
| Arm | Type | Receives |
|---|---|---|
| external intercostal plane block intervention with ultra sound | Active comparator | Procedure: External intercostal plane puncturePatients in this group will receive (EOIPB) bilaterally, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine injected into the external oblique intercostal plane on each side. |
| single-puncture technique of (RSB) combined with (TAPB) by ultra sound | Active comparator | Procedure: the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block)Patients in this group will receive rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) bilaterally via single puncture, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine divided into 10 ml of 0.25% bupivacaine will be injected when the needle reaches the posterior rectus abdominis sheath and pierces the anterior layer of the posterior sheath, Then, the needle will break through the posterior layer of the tendon to the transversus abdominis plane and another 10 ml of 0.25% bupivacaine will be injected into transversus abdominis plane . |
| control group (nalbuphine) | Placebo comparator | Drug: control group (nalbuphine)Patients in this group will not receive any intervention or nerve block. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) 1-II
- aged 18-70 years
- both genders will be included.
- body mass index (BMI) ≤ 35 kg/m2.
Key exclusion criteria (7 listed)
- coagulation disorders
- liver/kidney disease
- History of abdominal surgery
- infection in the block application area
- chronic opioid use
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 |
|---|---|---|
| External intercostal plane puncturePatients in this group will receive external intercostal plane block bilaterally, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine injected into the external oblique intercostal plane on each side. | Procedure or surgery | external intercostal plane block intervention with ultra sound |
| control group (nalbuphine)Patients in this group will not receive any intervention or nerve block. | Drug | control group (nalbuphine) |
| the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block)Patients in this group will receive rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) bilaterally via single puncture, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine divided into 10 ml of 0.25% bupivacaine will be injected when the needle reaches the posterior rectus abdominis sheath and pierces the anterior layer of the posterior sheath, Then, the needle will break through the posterior layer of the tendon to the transversus abdominis plane and another 10 ml of 0.25% bupivacaine will be injected into transversus abdominis plane . | Procedure or surgery | single-puncture technique of (RSB) combined with (TAPB) by ultra sound |
Primary outcome
Decrase the consumption of opioids
Time frame: Intraoperative, immediately postoperative , 2 hours post operative , 4 hours post operative , 6 hours postoperative, 12 hours postoperative, 24 hours postoperative
The primary outcome of the study will be the amount of opoid (nalbuphine) consumption in the first 24 hours postoperatively.
3 secondary outcomes
The analgesic efficacy (sensory assessment)
Time frame: First hour, second hour , sixth hour, 12th hour , 24th hour postoperatively
Pain intensity
Time frame: Immediately postoperative, 2 hours postoperative, 4 hours postoperatively, 6 hours postoperative, 12 hours postoperative, 24 hours postoperative
Off bed activity
Time frame: 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 38336613Yu S, Wen Y, Lin J, Yang J, He Y, Zuo Y. Combined rectus sheath block with transverse abdominis plane block by one puncture for analgesia after laparoscopic upper abdominal surgery: a randomized controlled prospective study. BMC Anesthesiol. 2024 Feb 9;24(1):58. doi: 10.1186/s12871-024-02444-6.
- White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. PMID: 35249704.Link provided by the sponsor.
- Yu S, Wen Y, Lin J, Yang J, He Y, Zuo Y. Combined rectus sheath block with transverse abdominis plane block by one puncture for analgesia after laparoscopic upper abdominal surgery: a randomized controlled prospective study. BMC Anesthesiol. 2024 Feb 9;2Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Menna Tallah Mamdouh Lecturer, Lecturer contact
Questions about this trial
What is this clinical trial studying?
A study testing External intercostal plane puncture and the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block) in people with Pain Management and Anesthesia , Analgesia, run by Minia University.
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: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama Mohamed, Master degree (+201013833227 ext. +201033231080, Usamakhaled286@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrase the consumption of opioids (time frame: Intraoperative, immediately postoperative , 2 hours post operative , 4 hours post operative , 6 hours postoperative, 12 hours postoperative, 24 hours postoperative). 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 NCT07384000, 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 3 Feb 2026.