Postoperative PainNCT07193472
Serratus Intercostal Plane Block Versus Port Infiltration in Laparoscopic Cholecystectomy
A study testing serratus intercostal plane block as analgesic technique in people with Postoperative Pain, run by Hospital del Rio Hortega at 1 site in Spain.
Trial summary
Most patients undergoing laparoscopic cholecystectomy (LC) experience moderate to severe pain in the first 24 hours after surgery. Port infiltration is the usual analgesic method while serratus-intercostal plane blockade (SIPB) has shown its efficacy in open cholecystectomy pain control. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- serratus intercostal plane block as analgesic technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jun 2025to 31 Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II-III
- laparoscopic cholecystectomy
Who cannot join
- Alergy to used drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Serratus Intercostal Plane Block Versus Port Infiltration in Laparoscopic Cholecystectomy: Randomised Clinical Trial
Most patients undergoing laparoscopic cholecystectomy (LC) experience moderate to severe pain in the first 24 hours after surgery. Port infiltration is the usual analgesic method while serratus-intercostal plane blockade (SIPB) has shown its efficacy in open cholecystectomy pain control. The aim of the present study was to compare the efficacy of both techniques in pain control.
OBJECTIVE The prospective randomised study has the working hypothesis is based on evaluating whether serratus-intercostal block (modified BRILMA) is equal or superior to laparoscopic port infiltration (PI) in terms of quality of postoperative recovery and pain control.
Read more
Secondary objectives of the study will be to assess the absence of adverse effects.
MATERIAL AND METHODS the investigators present a low-intervention clinical trial. The sample will be composed of 128 patients divided into two groups according to the analgesic technique (serratus-intercostal and port infiltration), following a 1:1 randomisation, consecutively until the sample size is reached and fulfilling the following criteria: signature of informed consent, over 18 years of age, ASA I-III, undergoing laparoscopic cholecystectomy.
Intraoperatively, patients will receive standard monitoring and induction. Analgesia will consist of a multimodal strategy (8 mg dexamethasone, 1 g paracetamol and 50 mg dexketoprofen pre-incisionally, intraoperative fentanyl on demand and the corresponding regional technique).
In the postoperative period, the main variable to be evaluated in forms designed for this purpose will be the difference in pain assessed by means of an numeric rating scale (NRS scale) and the quality of recovery will be measured by means of the modified Postoperative Quality of Recovery Score (QoR-15 ) recovery scale (15 responses).
Read the detailed description
Background
Postoperative pain remains a significant concern following laparoscopic cholecystectomy (LC), with most patients experiencing moderate to severe pain within the first 24 hours. Traditionally, port-site infiltration (PI) with local anesthetics is employed for analgesia. However, the serratus-intercostal plane block (SIPB), also known as the modified BRILMA block, has demonstrated efficacy in pain management for open cholecystectomy. Its role in LC remains to be clarified.
Objective
The primary objective of this prospective randomised study is to evaluate whether SIPB (modified BRILMA block) provides equivalent or superior postoperative analgesia and quality of recovery compared to port-site infiltration in patients undergoing LC.
Secondary objective: To assess the incidence of adverse effects related to each analgesic technique.
Methods
This study is designed as a low-intervention, prospective, randomized clinical trial. A total of 128 adult patients (ASA I-III) scheduled for elective laparoscopic cholecystectomy will be randomly allocated (1:1) to receive either serratus-intercostal plane block or laparoscopic port infiltration for perioperative analgesia. Randomization will be performed consecutively until the target sample size is reached.
Inclusion Criteria:
Age ≥ 18 years
ASA physical status I-III
Informed consent provided
Exclusion Criteria:
(Coagulopaty, allergy to local anaesthetic, history of chronic pain)
Intraoperative Management:
All patients will receive standardized general anesthesia and multimodal analgesia comprising:
8 mg dexamethasone
1 g paracetamol
50 mg dexketoprofen (administered pre-incisionally)
Fentanyl as needed during surgery
Assigned regional analgesic technique (SIPB or PI)
Postoperative Evaluation:
Primary Outcome Measures:
Pain intensity using the Numerical Rating Scale (NRS) at predefined intervals
Quality of recovery assessed via the modified QoR-15 questionnaire
Secondary Outcome Measure:Incidence of adverse events or complications related to the analgesic techniques
SIPB group: receive The Serratus intercostal plane block as analgesic technique after induction. With the patient lying in supine position, the local anaesthetic is administered in the plane under Serratus muscle at the 8th rib level Infiltration group: in this group the surgeons administered local anaesthetic after inserting the trocar.
Conclusion (anticipated)
This trial aims to determine whether SIPB offers superior analgesic efficacy and recovery quality compared to standard port infiltration in LC, potentially informing improved postoperative pain protocols.
- Conditions
- Postoperative Pain
- Being tested
- serratus intercostal plane block as analgesic technique
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus intercostal plane block as analgesic techniqueProcedure or surgery
the SIPB will be applied after starting surgery and before general anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| port infiltration | Other | patients receiving port infiltration as analgesia Receives: Procedure: serratus intercostal plane block as analgesic technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
efectiveness of analgesia (SIPB versus IP)
The working hypothesis is based on evaluating whether serratus-intercostal block (modified BRILMA) is equal or superior to laparoscopic port infiltration (PI) in terms of quality of postoperative recovery (QoR15) and pain control (NRS) 0-10
Measured: one year
Secondary outcomes (3)
side efects
assesment of side efects
Measured: one year
Postoperative pain control
Pain developed for patients after surgery first 24 h . nRS 0-10
Measured: One year
Postoperative recovery
Intake, rest at night, walking…assessed with QoR15 0- 150
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start2 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Teresa Fernandez, Hospital del Rio Hortega
- Investigators
- Maria Teresa Fernandez, MD, Principal investigator, Hospital del Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193472
- Sponsor's protocol ID
- PI-25- 298-H
- Other IDs
- PI-25- 298-H
- Status last verified
- Sep 2025
- First submitted
- 24 Jun 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Serratus Intercostal Plane Block Versus Port Infiltration in Laparoscopic Cholecystectomy: Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07193472
- Acronym / sponsor ID
- PI-25- 298-H
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Sep 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.
Most patients undergoing laparoscopic cholecystectomy (LC) experience moderate to severe pain in the first 24 hours after surgery. Port infiltration is the usual analgesic method while serratus-intercostal plane blockade (SIPB) has shown its efficacy in open cholecystectomy pain control. The aim of the present study was to compare the efficacy of both techniques in pain control.
OBJECTIVE The prospective randomised study has the working hypothesis is based on evaluating whether serratus-intercostal block (modified BRILMA) is equal or superior to laparoscopic port infiltration (PI) in terms of quality of postoperative recovery and pain control.
Secondary objectives of the study will be to assess the absence of adverse effects.
MATERIAL AND METHODS the investigators present a low-intervention clinical trial. The sample will be composed of 128 patients divided into two groups according to the analgesic technique (serratus-intercostal and port infiltration), following a 1:1 randomisation, consecutively until the sample size is reached and fulfilling the following criteria: signature of informed consent, over 18 years of age, ASA I-III, undergoing laparoscopic cholecystectomy.
Intraoperatively, patients will receive standard monitoring and induction. Analgesia will consist of a multimodal strategy (8 mg dexamethasone, 1 g paracetamol and 50 mg dexketoprofen pre-incisionally, intraoperative fentanyl on demand and the corresponding regional technique).
In the postoperative period, the main variable to be evaluated in forms designed for this purpose will be the difference in pain assessed by means of an numeric rating scale (NRS scale) and the quality of recovery will be measured by means of the modified Postoperative Quality of Recovery Score (QoR-15 ) recovery scale (15 responses).
Detailed description
Background
Postoperative pain remains a significant concern following laparoscopic cholecystectomy (LC), with most patients experiencing moderate to severe pain within the first 24 hours. Traditionally, port-site infiltration (PI) with local anesthetics is employed for analgesia. However, the serratus-intercostal plane block (SIPB), also known as the modified BRILMA block, has demonstrated efficacy in pain management for open cholecystectomy. Its role in LC remains to be clarified.
Objective
The primary objective of this prospective randomised study is to evaluate whether SIPB (modified BRILMA block) provides equivalent or superior postoperative analgesia and quality of recovery compared to port-site infiltration in patients undergoing LC.
Secondary objective: To assess the incidence of adverse effects related to each analgesic technique.
Methods
This study is designed as a low-intervention, prospective, randomized clinical trial. A total of 128 adult patients (ASA I-III) scheduled for elective laparoscopic cholecystectomy will be randomly allocated (1:1) to receive either serratus-intercostal plane block or laparoscopic port infiltration for perioperative analgesia. Randomization will be performed consecutively until the target sample size is reached.
Inclusion Criteria:
Age ≥ 18 years
ASA physical status I-III
Informed consent provided
Exclusion Criteria:
(Coagulopaty, allergy to local anaesthetic, history of chronic pain)
Intraoperative Management:
All patients will receive standardized general anesthesia and multimodal analgesia comprising:
8 mg dexamethasone
1 g paracetamol
50 mg dexketoprofen (administered pre-incisionally)
Fentanyl as needed during surgery
Assigned regional analgesic technique (SIPB or PI)
Postoperative Evaluation:
Primary Outcome Measures:
Pain intensity using the Numerical Rating Scale (NRS) at predefined intervals
Quality of recovery assessed via the modified QoR-15 questionnaire
Secondary Outcome Measure:Incidence of adverse events or complications related to the analgesic techniques
SIPB group: receive The Serratus intercostal plane block as analgesic technique after induction. With the patient lying in supine position, the local anaesthetic is administered in the plane under Serratus muscle at the 8th rib level Infiltration group: in this group the surgeons administered local anaesthetic after inserting the trocar.
Conclusion (anticipated)
This trial aims to determine whether SIPB offers superior analgesic efficacy and recovery quality compared to standard port infiltration in LC, potentially informing improved postoperative pain protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| port infiltration | Other | Procedure: serratus intercostal plane block as analgesic techniquepatients receiving port infiltration as analgesia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II-III
- laparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- Alergy to used drugs
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 |
|---|---|---|
| serratus intercostal plane block as analgesic techniquethe SIPB will be applied after starting surgery and before general anaesthesia | Procedure or surgery | port infiltration |
Primary outcome
efectiveness of analgesia (SIPB versus IP)
Time frame: one year
The working hypothesis is based on evaluating whether serratus-intercostal block (modified BRILMA) is equal or superior to laparoscopic port infiltration (PI) in terms of quality of postoperative recovery (QoR15) and pain control (NRS) 0-10
3 secondary outcomes
side efects
Time frame: one year
Postoperative pain control
Time frame: One year
Postoperative recovery
Time frame: One year
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 25 Sep 2026.
- 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.
Maria Teresa Fernandez, MD principal investigator
Hospital del Rio Hortega
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serratus intercostal plane block as analgesic technique in people with Postoperative Pain, run by Hospital del Rio Hortega at 1 site in Spain.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 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 Spain. 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?
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?
efectiveness of analgesia (SIPB versus IP) (time frame: one year). 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 25 Sep 2026.