Postoperative PainNCT07332546
EOIB for Pain After Laparoscopic Cholecystectomy
A study testing External oblique intercostal block (EOIB) in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Shiyou Wei at 1 site in China.
Trial summary
This prospective, randomized, controlled, assessor-blinded trial will evaluate whether bilateral ultrasound-guided external oblique intercostal block (EOIB) reduces postoperative opioid consumption and improves recovery after laparoscopic cholecystectomy, compared with no block. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain, Laparoscopic Cholecystectomy
- What is being tested?
- External oblique intercostal block (EOIB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 25 Jun 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-85 years, regardless of gender
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Scheduled for elective laparoscopic cholecystectomy
- Ability to use the intravenous patient-controlled analgesia (IV PCA) system
Who cannot join
- Hepatic disease (e.g., liver enzyme levels ≥ 2× the upper limit of normal)
- Renal disease (e.g., serum creatinine levels ≥ 2× the upper limit of normal)
- Allergy or known hypersensitivity to local anesthetics
- Females who are pregnant or lactating
- Conversion to open surgery
- Coagulopathy or current use of anticoagulant medications
- Opioid use for more than 2 weeks in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Oblique Intercostal Block for Postoperative Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
This prospective, randomized, controlled, assessor-blinded trial will evaluate whether bilateral ultrasound-guided external oblique intercostal block (EOIB) reduces postoperative opioid consumption and improves recovery after laparoscopic cholecystectomy, compared with no block.
Read the detailed description
Laparoscopic cholecystectomy is a common procedure, yet postoperative pain remains clinically significant despite routine multimodal analgesia, and opioid use may cause adverse effects. External oblique intercostal block (EOIB) is a newer ultrasound-guided fascial plane block that may provide effective analgesia for upper abdominal surgery.
This study is a prospective, randomized, controlled, assessor-blinded trial in patients undergoing elective laparoscopic cholecystectomy. A total of 56 participants will be randomized 1:1 to receive either bilateral ultrasound-guided EOIB or no regional block. EOIB will be performed bilaterally under ultrasound guidance at the level of the 6th rib in the 6th-7th intercostal space using an in-plane technique, with 15 mL of study local anesthetic mixture injected per side. Postoperatively, all participants will receive standardized multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with butorphanol and non-opioid analgesics per protocol.
The primary outcome is total opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores (VRS) at prespecified time points, quality of recovery (QoR-15) at 24 hours, opioid consumption from 24-48 hours, postoperative nausea and vomiting, intraoperative hemodynamic events, time to first flatus, and length of hospital stay. The trial aims to determine whether adding bilateral EOIB to standard analgesia can reduce opioid requirements and improve recovery after laparoscopic cholecystectomy.
- Conditions
- Postoperative Pain, Laparoscopic Cholecystectomy
- Being tested
- External oblique intercostal block (EOIB), Standard care without regional block
- Keywords
- External oblique intercostal block, Ultrasonography, Interventional, Nerve Block, Quality of recovery (QoR-15)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External oblique intercostal block (EOIB)Other
Bilateral ultrasound-guided external oblique intercostal block performed under sterile conditions after induction of general anesthesia and before surgical incision. Using an in-plane technique, the block is performed at the level of the 6th rib in the 6th-7th intercostal space. A local anesthetic mixture is injected with a total volume of 15 mL per side (prepared by mixing 0.75% ropivacaine with normal saline).
Standard care without regional blockOther
Participants do not receive any regional anesthesia/nerve block (including external oblique intercostal block). All participants receive standard general anesthesia and the same standardized postoperative multimodal analgesia regimen as per protocol, including intravenous patient-controlled analgesia (PCA) with butorphanol.
| Study group | Role | What they receive |
|---|---|---|
| EOIB Group | Experimental | Participants receive bilateral ultrasound-guided external oblique intercostal block (EOIB) (15 mL of the study local anesthetic mixture per side) in addition to standard general anesthesia and standardized postoperative analgesia (IV PCA butorphanol ). Receives: Other: External oblique intercostal block (EOIB) |
| Control Group | Sham comparator | Participants do not receive any regional block. They receive standard general anesthesia and standardized postoperative analgesia only (IV PCA butorphanol). Receives: Other: Standard care without regional block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Butorphanolconsumption in the first 24 hours after surgery
Total Butorphanol consumption during the first 24 hours postoperatively. A relative difference of 30% is considered clinically significant.
Measured: 0-24 hours after surgery
Secondary outcomes (8)
Pain score (VRS) at 24 hours after surgery
Postoperative pain intensity measured using the Verbal Rating Scale (VRS; 0 = no pain, 10 = worst pain imaginable) at 24 hours after surgery.
Measured: 24 hours after surgery
Quality of recovery at 24 hours (QoR-15 score)
Quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15); total score at 24 hours postoperatively.
Measured: 24 hours after surgery
Butorphanol consumption from 24 to 48 hours after surgery
Total butorphanol consumption recorded during postoperative hours 24-48 (including PCA-delivered dose and any additional butorphanol administered).
Measured: 24-48 hours after surgery
Pain score (VRS) at 48 and 72 hours after surgery
Postoperative pain intensity measured using the Verbal Rating Scale (VRS; 0-10) at 48 hours and 72 hours after surgery.
Measured: 48 hours and 72 hours after surgery
Incidence of postoperative nausea and vomiting within 72 hours
Incidence of nausea and/or vomiting recorded during postoperative time intervals (1-6 h, 7-24 h, 25-48 h, and 49-72 h); summarized up to 72 hours.
Measured: 1-6 hours, 7-24 hours, 25-48 hours, and 49-72 hours after surgery (up to 72 hours)
Incidence of intraoperative hypotension and hypertension
Incidence of intraoperative hypotension and intraoperative hypertension during surgery, recorded per protocol definitions. Blood pressure increase exceeding 30% of the baseline value is used as the measurement criterion.
Measured: Intraoperative period
Time to first flatus
Time from the end of surgery to the first passage of flatus.
Measured: Within 3 days after surgery
Postoperative length of hospital stay
Duration of hospital stay after surgery, measured from the time of surgery to hospital discharge.
Measured: Within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 Jan 2026
- Primary completion22 Jun 2026
- Study completion25 Jun 2026
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 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 are randomized 1:1 to one of two parallel groups: bilateral ultrasound-guided external oblique intercostal block (EOIB) or control (no regional block). Each participant receives only the assigned intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiyou Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Xin Lv, PhD, Study chair, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332546
- Sponsor's protocol ID
- 20250322
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei S, Yu J, Huang J, Xiang Z, Song J, Lv X, Li X. Bilateral external oblique intercostal block combined with intravenous patient-controlled analgesia for multimodal analgesia after laparoscopic cholecystectomy: a single-center randomized controlled trial. Surg Endosc. 2026 Oct 7. doi: 10.1007/s00464-026-13498-7. Online ahead of print.
PubMed 42844372
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Oblique Intercostal Block for Postoperative Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07332546
- Acronym / sponsor ID
- 20250322
- Conditions
- Postoperative Pain, Laparoscopic Cholecystectomy
- Keywords
- External oblique intercostal block, Ultrasonography, Interventional, Nerve Block, Quality of recovery (QoR-15)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 12 Jan 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, assessor-blinded trial will evaluate whether bilateral ultrasound-guided external oblique intercostal block (EOIB) reduces postoperative opioid consumption and improves recovery after laparoscopic cholecystectomy, compared with no block.
Detailed description
Laparoscopic cholecystectomy is a common procedure, yet postoperative pain remains clinically significant despite routine multimodal analgesia, and opioid use may cause adverse effects. External oblique intercostal block (EOIB) is a newer ultrasound-guided fascial plane block that may provide effective analgesia for upper abdominal surgery.
This study is a prospective, randomized, controlled, assessor-blinded trial in patients undergoing elective laparoscopic cholecystectomy. A total of 56 participants will be randomized 1:1 to receive either bilateral ultrasound-guided EOIB or no regional block. EOIB will be performed bilaterally under ultrasound guidance at the level of the 6th rib in the 6th-7th intercostal space using an in-plane technique, with 15 mL of study local anesthetic mixture injected per side. Postoperatively, all participants will receive standardized multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with butorphanol and non-opioid analgesics per protocol.
The primary outcome is total opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores (VRS) at prespecified time points, quality of recovery (QoR-15) at 24 hours, opioid consumption from 24-48 hours, postoperative nausea and vomiting, intraoperative hemodynamic events, time to first flatus, and length of hospital stay. The trial aims to determine whether adding bilateral EOIB to standard analgesia can reduce opioid requirements and improve recovery after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to one of two parallel groups: bilateral ultrasound-guided external oblique intercostal block (EOIB) or control (no regional block). Each participant receives only the assigned intervention.
| Arm | Type | Receives |
|---|---|---|
| EOIB Group | Experimental | Other: External oblique intercostal block (EOIB)Participants receive bilateral ultrasound-guided external oblique intercostal block (EOIB) (15 mL of the study local anesthetic mixture per side) in addition to standard general anesthesia and standardized postoperative analgesia (IV PCA butorphanol ). |
| Control Group | Sham comparator | Other: Standard care without regional blockParticipants do not receive any regional block. They receive standard general anesthesia and standardized postoperative analgesia only (IV PCA butorphanol). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-85 years, regardless of gender
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Scheduled for elective laparoscopic cholecystectomy
- Ability to use the intravenous patient-controlled analgesia (IV PCA) system
Key exclusion criteria (7 listed)
- Hepatic disease (e.g., liver enzyme levels ≥ 2× the upper limit of normal)
- Renal disease (e.g., serum creatinine levels ≥ 2× the upper limit of normal)
- Allergy or known hypersensitivity to local anesthetics
- Females who are pregnant or lactating
- Conversion to open surgery
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 oblique intercostal block (EOIB)Bilateral ultrasound-guided external oblique intercostal block performed under sterile conditions after induction of general anesthesia and before surgical incision. Using an in-plane technique, the block is performed at the level of the 6th rib in the 6th-7th intercostal space. A local anesthetic mixture is injected with a total volume of 15 mL per side (prepared by mixing 0.75% ropivacaine with normal saline). | Other | EOIB Group |
| Standard care without regional blockParticipants do not receive any regional anesthesia/nerve block (including external oblique intercostal block). All participants receive standard general anesthesia and the same standardized postoperative multimodal analgesia regimen as per protocol, including intravenous patient-controlled analgesia (PCA) with butorphanol. | Other | Control Group |
Primary outcome
Total Butorphanolconsumption in the first 24 hours after surgery
Time frame: 0-24 hours after surgery
Total Butorphanol consumption during the first 24 hours postoperatively. A relative difference of 30% is considered clinically significant.
8 secondary outcomes
Pain score (VRS) at 24 hours after surgery
Time frame: 24 hours after surgery
Quality of recovery at 24 hours (QoR-15 score)
Time frame: 24 hours after surgery
Butorphanol consumption from 24 to 48 hours after surgery
Time frame: 24-48 hours after surgery
Pain score (VRS) at 48 and 72 hours after surgery
Time frame: 48 hours and 72 hours after surgery
Incidence of postoperative nausea and vomiting within 72 hours
Time frame: 1-6 hours, 7-24 hours, 25-48 hours, and 49-72 hours after surgery (up to 72 hours)
Incidence of intraoperative hypotension and hypertension
Time frame: Intraoperative period
Time to first flatus
Time frame: Within 3 days after surgery
Postoperative length of hospital stay
Time frame: Within 7 days 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 7 Jul 2026.
- Derived from this study: PubMed 42844372Wei S, Yu J, Huang J, Xiang Z, Song J, Lv X, Li X. Bilateral external oblique intercostal block combined with intravenous patient-controlled analgesia for multimodal analgesia after laparoscopic cholecystectomy: a single-center randomized controlled trial. Surg Endosc. 2026 Oct 7. doi: 10.1007/s00464-026-13498-7. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Xin Lv, PhD study chair
Shanghai Pulmonary Hospital, Tongji University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External oblique intercostal block (EOIB) in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Shiyou Wei at 1 site in China.
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 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 7 Jul 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 China. 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. 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?
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?
Total Butorphanolconsumption in the first 24 hours after surgery (time frame: 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 NCT07332546, 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 7 Jul 2026.