Pain, PostoperativePBLIMNCT06451705
Pecs Block vs Local Infiltration in Mastectomy
A study testing PECS II block and LIA in people with Pain, Postoperative, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
Studied the comparison between PECS II block and LIA on pain intensity, opioid requirements, RNL, and postoperative IL-6 levels in MRM patients. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- PECS II block and LIA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2024to 30 Apr 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-60 years old.
- Body weight (BW): 50-70 kg.
- Height (TB): 150-170 cm.
- Body mass index (BMI): 18.5-29.9 kg/m2.
- American Society of Anesthesiologists physical status (ASA PS) class I-II.
- Patients undergoing elective MRM surgery under general anesthesia.
Who cannot join
- Patients with contraindications to PECS II block.
- Patients with contraindications to LIA.
- Patients with coagulation disorders or receiving anticoagulant therapy.
- Patients with a history of chronic pain.
- Patients with a history of allergy to study materials.
- Patients with a history of previous breast surgery.
- Patient refuses to participate in the study.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUP dr. Wahidin Sudirohusodo
Makassar, South Sulawesi, 90173
About this study
Official title: Comparison Between Pectoral Nerve Block II and Local Anesthesia Infiltration of Isobaric Bupivacaine 0.25% 50 MG on Neutrophil-Lymphocyte Ratio, Interleukin-6 Levels, Pain Intensity, and Post-surgical Opioid Requirements in Modified Radical Mastectomy Patients
Studied the comparison between PECS II block and LIA on pain intensity, opioid requirements, RNL, and postoperative IL-6 levels in MRM patients.
- Conditions
- Pain, Postoperative
- Being tested
- PECS II block, LIA
- Keywords
- postoperative pain, modified radical mastectomy, peripheral nerve block, local infiltration anesthesia, pectoralis nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS II blockDrug
Treatment group that received the PECS II block using isobaric bupivacaine 0.5% 50 mg
LIADrug
Treatment group that received the local infiltration anesthesia using isobaric bupivacaine 0.5% 50 mg
| Study group | Role | What they receive |
|---|---|---|
| PECS | Active comparator | PECS II block before surgery using isobaric bupivacaine 0.25% 20 mL (50 mg) Receives: Drug: PECS II block |
| LIA | Active comparator | Local infiltration anesthesia after completion of surgery using isobaric bupivacaine 0.25% 20 mL (50 mg) Receives: Drug: LIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Plasma Interleukin-6
in pg/dL
Measured: 1 hour before surgery, 2 hour after surgery, 12 hour after surgery
Neutrophil-lymphocyte ratio
Neutrophil divided by lymphocyte
Measured: 1 hour before surgery, 2 hour after surgery, 12 hour after surgery
Pain intensity (Using Numeric Rating Scale)
Scale from 0-10, lower score = better outcome
Measured: hour 0, 2, 4, 6, 12, 24
Rescue opioid requirement
Using fentanyl at a dose of 0.5-1 μg/kg/IV titrated as needed, in mcg (given if the patient had NRS of >4/10)
Measured: Within 24 hours after surgery
Secondary outcomes (3)
Demographic baseline data
Medical record number, age, body weight (in kilogram), height (in centimeter), BMI (in kg/m2), ASA PS class, duration of surgery (in minutes)
Measured: baseline (before the surgery)
Time until first rescue opioid requirement
in minutes
Measured: Within 24 hours after surgery
Nausea and vomiting
Nausea and vomiting were assessed using a numerical scale (0 = no nausea, 1 = mild nausea, 2 = severe nausea or vomiting once, and 3 = vomiting more than once). If the score was > 2, rescue antiemetics with ondansetron 0.1 mg/IV were given.
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 posted11 Jun 2024
- Study start1 Mar 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- single-blind randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jokevin Prasetyadhi, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451705
- Sponsor's protocol ID
- 173/UN4.6.4.5.31/PP36/2AZ4
- Acronym
- PBLIM
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pectoral Nerve Block II and Local Anesthesia Infiltration of Isobaric Bupivacaine 0.25% 50 MG on Neutrophil-Lymphocyte Ratio, Interleukin-6 Levels, Pain Intensity, and Post-surgical Opioid Requirements in Modified Radical Mastectomy Patients
- ClinicalTrials.gov ID
- NCT06451705
- Acronym / sponsor ID
- PBLIM / 173/UN4.6.4.5.31/PP36/2AZ4
- Conditions
- Pain, Postoperative
- Keywords
- postoperative pain, modified radical mastectomy, peripheral nerve block, local infiltration anesthesia, pectoralis nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 11 Jun 2024 (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.
Studied the comparison between PECS II block and LIA on pain intensity, opioid requirements, RNL, and postoperative IL-6 levels in MRM patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blind randomized trial
| Arm | Type | Receives |
|---|---|---|
| PECS | Active comparator | Drug: PECS II blockPECS II block before surgery using isobaric bupivacaine 0.25% 20 mL (50 mg) |
| LIA | Active comparator | Drug: LIALocal infiltration anesthesia after completion of surgery using isobaric bupivacaine 0.25% 20 mL (50 mg) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18-60 years old.
- Body weight (BW): 50-70 kg.
- Height (TB): 150-170 cm.
- Body mass index (BMI): 18.5-29.9 kg/m2.
- American Society of Anesthesiologists physical status (ASA PS) class I-II.
Key exclusion criteria (7 listed)
- Patients with contraindications to PECS II block.
- Patients with contraindications to LIA.
- Patients with coagulation disorders or receiving anticoagulant therapy.
- Patients with a history of chronic pain.
- Patients with a history of allergy to study materials.
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 |
|---|---|---|
| PECS II blockTreatment group that received the PECS II block using isobaric bupivacaine 0.5% 50 mg | Drug | PECS |
| LIATreatment group that received the local infiltration anesthesia using isobaric bupivacaine 0.5% 50 mg | Drug | LIA |
Primary outcome
Concentration of Plasma Interleukin-6
Time frame: 1 hour before surgery, 2 hour after surgery, 12 hour after surgery
in pg/dL
Neutrophil-lymphocyte ratio
Time frame: 1 hour before surgery, 2 hour after surgery, 12 hour after surgery
Neutrophil divided by lymphocyte
Pain intensity (Using Numeric Rating Scale)
Time frame: hour 0, 2, 4, 6, 12, 24
Scale from 0-10, lower score = better outcome
Rescue opioid requirement
Time frame: Within 24 hours after surgery
Using fentanyl at a dose of 0.5-1 μg/kg/IV titrated as needed, in mcg (given if the patient had NRS of >4/10)
3 secondary outcomes
Demographic baseline data
Time frame: baseline (before the surgery)
Time until first rescue opioid requirement
Time frame: Within 24 hours after surgery
Nausea and vomiting
Time frame: Within 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 11 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PECS II block and LIA in people with Pain, Postoperative, run by Hasanuddin 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 6 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 11 Jun 2024. 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?
Concentration of Plasma Interleukin-6 (time frame: 1 hour before surgery, 2 hour after surgery, 12 hour after surgery). The study lists 4 primary outcomes in all. 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 11 Jun 2024.