Postoperative PainNCT07440940
Timing of Subcostal TAPB Combined With Rectus Sheath Block for Postoperative Pain After Laparoscopic Cholecystectomy
A study testing Ultrasound-guided subcostal TAP block combined with rectus sheath block in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Eulji University Hospital at 1 site in South Korea.
Trial summary
This prospective randomized controlled trial aims to evaluate whether the timing of ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) affects postoperative pain in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Laparoscopic Cholecystectomy
- What is being tested?
- Ultrasound-guided subcostal TAP block combined with rectus sheath block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Feb 2026to 15 Jan 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective laparoscopic cholecystectomy
- Adults aged 18 to 80 years
- Ability to understand the study procedures and provide informed consent
- American Society of Anesthesiologists (ASA) physical status I-III
Who cannot join
- Presence of significant pain unrelated to the target disease that may interfere with pain assessment
- Known allergy or contraindication to study medications (ropivacaine, acetaminophen, nefopam, or pethidine)
- Planned single-port laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical status IV or higher
- Infection of the abdominal wall or skin at the injection site, or anatomical abnormalities of the abdominal wall
- Major neurological, psychiatric, or systemic diseases that may affect pain perception, treatment response, or study evaluation
Show all 10Show fewer
- Requirement for postoperative mechanical ventilation
- Pregnancy or breastfeeding
- Considered unsuitable for the study by the investigator
- Refusal to participate or inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Nowon Eulji University Hospital
Seoul, 01830
Hye-yeon Cho, MD, +82-2-970-8705, anesthesia_chy@eulji.ac.kr
About this study
Official title: Effect of Timing of Ultrasound-Guided Subcostal Transversus Abdominis Plane Block Combined With Rectus Sheath Block on Postoperative Pain in Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
This prospective randomized controlled trial aims to evaluate whether the timing of ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) affects postoperative pain in patients undergoing laparoscopic cholecystectomy.
Participants will be randomly assigned to receive the combined regional blocks either before surgical incision or after completion of surgery. The primary outcome is postoperative pain intensity measured using a numerical rating scale. Secondary outcomes include opioid consumption, incidence of postoperative nausea and vomiting, and other recovery parameters.
The results of this study may help optimize the timing of abdominal wall blocks to improve postoperative analgesia and recovery following laparoscopic cholecystectomy.
Read the detailed description
Postoperative pain after laparoscopic cholecystectomy remains a significant clinical concern despite the minimally invasive nature of the procedure. Ultrasound-guided abdominal wall blocks, including subcostal transversus abdominis plane (TAP) block and rectus sheath block (RSB), are widely used to reduce postoperative pain and opioid requirements. However, the optimal timing of block administration relative to surgical incision remains unclear.
This prospective, single-center, randomized controlled trial will compare the analgesic efficacy of pre-incisional versus post-operative administration of combined ultrasound-guided subcostal TAP block and RSB in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Participants will be randomized in a 1:1 ratio using block randomization with randomly permuted block sizes. Standardized general anesthesia and postoperative analgesia protocols will be applied to all participants.
The primary outcome will be postoperative pain intensity measured using a numerical rating scale at predefined time points after surgery. Secondary outcomes will include cumulative opioid consumption, incidence of postoperative nausea and vomiting, rescue analgesic requirements, and recovery profiles.
The findings of this study are expected to provide evidence for optimizing the timing of abdominal wall block administration to improve postoperative analgesia and patient recovery after laparoscopic cholecystectomy.
- Conditions
- Postoperative Pain, Laparoscopic Cholecystectomy
- Being tested
- Ultrasound-guided subcostal TAP block combined with rectus sheath block
- Keywords
- Laparoscopic Cholecystectomy, Transversus Abdominis Plane Block, Rectus Sheath Block, Postoperative pain
- 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 subcostal TAP block combined with rectus sheath blockProcedure or surgery
Ultrasound-guided right subcostal transversus abdominis plane (TAP) block combined with bilateral rectus sheath block (RSB) is performed under sterile conditions using local anesthetic for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Pre-incisional Block Group | Experimental | Participants receive ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) after induction of general anesthesia and before surgical incision. Receives: Procedure: Ultrasound-guided subcostal TAP block combined with rectus sheath block |
| Postoperative Block Group | Experimental | Participants receive ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) after completion of surgery and before emergence from anesthesia. Receives: Procedure: Ultrasound-guided subcostal TAP block combined with rectus sheath block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum postoperative pain intensity within 24 hours
The highest postoperative pain intensity measured using an 11-point numeric rating scale (NRS; 0 = no pain, 10 = worst pain imaginable) during the first 24 hours after surgery, assessed at 1, 6, 12, and 24 hours postoperatively.
Measured: Within 24 hours after surgery
Secondary outcomes (3)
Maximum postoperative pain intensity during post-anesthesia care unit stay
The highest postoperative pain intensity measured using an 11-point numeric rating scale (NRS; 0 = no pain, 10 = worst pain imaginable) during the recovery period.
Measured: During the post-anesthesia care unit stay
Cumulative rescue opioid consumption within 24 hours
Total amount of rescue opioid administered between 1 and 24 hours after surgery.
Measured: Within 24 hours after surgery
Incidence of postoperative nausea and vomiting
Occurrence of nausea or vomiting during the postoperative period.
Measured: Within 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 posted27 Feb 2026
- Study start23 Feb 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
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
- Participants will be randomly assigned in a 1:1 ratio to receive the combined ultrasound-guided subcostal TAP block and rectus sheath block either before surgical incision or after completion of surgery.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eulji University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye-yeon Cho, Eulji University Hospital
- Investigators
- Hye-yeon Cho, Principal investigator, Nowon Eulji University Hospital, Eulji University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440940
- Sponsor's protocol ID
- 2026-01-026
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Timing of Ultrasound-Guided Subcostal Transversus Abdominis Plane Block Combined With Rectus Sheath Block on Postoperative Pain in Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07440940
- Acronym / sponsor ID
- 2026-01-026
- Conditions
- Postoperative Pain, Laparoscopic Cholecystectomy
- Keywords
- Laparoscopic Cholecystectomy, Transversus Abdominis Plane Block, Rectus Sheath Block, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Eulji University HospitalUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 27 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 prospective randomized controlled trial aims to evaluate whether the timing of ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) affects postoperative pain in patients undergoing laparoscopic cholecystectomy.
Participants will be randomly assigned to receive the combined regional blocks either before surgical incision or after completion of surgery. The primary outcome is postoperative pain intensity measured using a numerical rating scale. Secondary outcomes include opioid consumption, incidence of postoperative nausea and vomiting, and other recovery parameters.
The results of this study may help optimize the timing of abdominal wall blocks to improve postoperative analgesia and recovery following laparoscopic cholecystectomy.
Detailed description
Postoperative pain after laparoscopic cholecystectomy remains a significant clinical concern despite the minimally invasive nature of the procedure. Ultrasound-guided abdominal wall blocks, including subcostal transversus abdominis plane (TAP) block and rectus sheath block (RSB), are widely used to reduce postoperative pain and opioid requirements. However, the optimal timing of block administration relative to surgical incision remains unclear.
This prospective, single-center, randomized controlled trial will compare the analgesic efficacy of pre-incisional versus post-operative administration of combined ultrasound-guided subcostal TAP block and RSB in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Participants will be randomized in a 1:1 ratio using block randomization with randomly permuted block sizes. Standardized general anesthesia and postoperative analgesia protocols will be applied to all participants.
The primary outcome will be postoperative pain intensity measured using a numerical rating scale at predefined time points after surgery. Secondary outcomes will include cumulative opioid consumption, incidence of postoperative nausea and vomiting, rescue analgesic requirements, and recovery profiles.
The findings of this study are expected to provide evidence for optimizing the timing of abdominal wall block administration to improve postoperative analgesia and patient recovery after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive the combined ultrasound-guided subcostal TAP block and rectus sheath block either before surgical incision or after completion of surgery.
| Arm | Type | Receives |
|---|---|---|
| Pre-incisional Block Group | Experimental | Procedure: Ultrasound-guided subcostal TAP block combined with rectus sheath blockParticipants receive ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) after induction of general anesthesia and before surgical incision. |
| Postoperative Block Group | Experimental | Procedure: Ultrasound-guided subcostal TAP block combined with rectus sheath blockParticipants receive ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) after completion of surgery and before emergence from anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective laparoscopic cholecystectomy
- Adults aged 18 to 80 years
- Ability to understand the study procedures and provide informed consent
- American Society of Anesthesiologists (ASA) physical status I-III
Key exclusion criteria (10 listed)
- Presence of significant pain unrelated to the target disease that may interfere with pain assessment
- Known allergy or contraindication to study medications (ropivacaine, acetaminophen, nefopam, or pethidine)
- Planned single-port laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical status IV or higher
- Infection of the abdominal wall or skin at the injection site, or anatomical abnormalities of the abdominal wall
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 subcostal TAP block combined with rectus sheath blockUltrasound-guided right subcostal transversus abdominis plane (TAP) block combined with bilateral rectus sheath block (RSB) is performed under sterile conditions using local anesthetic for postoperative analgesia. | Procedure or surgery | Postoperative Block Group, Pre-incisional Block Group |
Primary outcome
Maximum postoperative pain intensity within 24 hours
Time frame: Within 24 hours after surgery
The highest postoperative pain intensity measured using an 11-point numeric rating scale (NRS; 0 = no pain, 10 = worst pain imaginable) during the first 24 hours after surgery, assessed at 1, 6, 12, and 24 hours postoperatively.
3 secondary outcomes
Maximum postoperative pain intensity during post-anesthesia care unit stay
Time frame: During the post-anesthesia care unit stay
Cumulative rescue opioid consumption within 24 hours
Time frame: Within 24 hours after surgery
Incidence of postoperative nausea and vomiting
Time frame: Within 24 hours after surgery
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 27 Feb 2026.
- 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.
Hye-yeon Cho principal investigator
Nowon Eulji University Hospital, Eulji University College of Medicine
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 subcostal TAP block combined with rectus sheath block in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Eulji University Hospital at 1 site in South Korea.
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 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: looking for participants now, as of the sponsor's last update on 27 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 South Korea. 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?
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 Hye-Yeon Cho, MD (+82-2-970-8705, anesthesia_chy@eulji.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum postoperative pain intensity within 24 hours (time frame: Within 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 27 Feb 2026.