Post-mastectomy Pain SyndromeNCT06443619
Efficacy of Glucose in Serratus Anterior Plane Block to Reduce the Occurrence of Chronic Post-mastectomy Pain
A study testing unilateral USG-deep SAPB with glucose and unilateral USG-deep SAPB without glucose in people with Post-mastectomy Pain Syndrome, run by Mansoura University.
Trial summary
Nearly 50% of patients suffer from chronic pain following breast cancer surgery. Several regional anesthesia techniques, including paravertebral block, erector spinae plane block, pectoral nerves block, and serratus anterior plane block, have been applied for acute pain control and prevention of chronic pain after… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Post-mastectomy Pain Syndrome
- What is being tested?
- unilateral USG-deep SAPB with glucose and unilateral USG-deep SAPB without glucose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2024to 10 Jul 2025
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status I-II
- age ranging from 20 to 60 years
- scheduled for unilateral modified radical mastectomy
Who cannot join
- patient refusal to participate in the study
- infection at site of needle insertion
- hypersensitivity to the studied drugs
- psychotic disorders,
- bilateral MRM ,
- bleeding disorder
- chronic renal or hepatic diseases
About this study
Official title: Efficacy of Glucose Addition to Bupivacaine in Serratus Anterior Plane Block to Reduce the Occurrence of Chronic Post-mastectomy Pain: A Randomized Controlled Trial
Nearly 50% of patients suffer from chronic pain following breast cancer surgery. Several regional anesthesia techniques, including paravertebral block, erector spinae plane block, pectoral nerves block, and serratus anterior plane block, have been applied for acute pain control and prevention of chronic pain after breast cancer surgery. Exploiting the beneficial effect of glucose in regulating neuroinflammation and neuropathic pain, we hypothesize that the addition of glucose to bupivacaine could be superior to bupivacaine in ultrasound-guided SAPB in improving the quality of postoperative analgesia and preventing chronic pain after mastectomy. Patients will be randomly allocated into one of two equal groups (30 patients each ); the study group; Group I( B-D) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25 % isobaric bupivacaine with addition of 15ml glucose 5% to (30 ml total volume); Group (B-N) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25% isobaric bupivacaine to be diluted with 15ml isotonic saline (30 ml total volume). The occurence of postmastectomy pain, 3 months after surgery, will be the primary outcome.
Read the detailed description
Breast cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related death in women. Although early detection and treatment have increased survival rates, chronic postsurgical pain (CPSP) is one of the most common complications of breast cancer surgery.
Nearly 50% of patients suffer from chronic pain following breast cancer surgery which is known as Post Mastectomy Pain Syndrome (PMPS). There are several risk factors for PMPS, including younger age, invasive surgical interventions, adjuvant radiation therapy following surgery, and high pain score in the early postoperative period. Several regional anesthesia (RA) techniques, including paravertebral block (PVB), pectoral nerves (PECS) block, and the erector spinae plane block (ESPB), have been applied for acute pain control and prevention of chronic pain after breast cancer surgery (BCS).
Recently, the serratus anterior plane block (SAPB) has become a newer interfacial plane block that appears to be safe and easily performed under ultrasound (de la Torre et al., 2014). A study concluded that preoperative SAPB with ropivacaine reduced the prevalence of CPSP at 3 months postoperativelyfrom 51.7% to 25.6%. Various adjuvants like fentanyl, clonidine, magnesium sulphate, nalbuphine, and dexamethasone have been used with bupivacaine in different blocks for prolonging the duration of analgesia and prevention of chronic pain. Using glucose 5% has been progressively applied to treat many peripheral entrapment neuropathies and has been proven to have outstanding effects in a few high-quality studies. Glucose 5% could decrease neurogenic inflammation by impeding the discharge of substance P and calcitonin gene-related peptides, which are pro-nociceptive substances that contribute to neurogenic inflammation and neuropathic pain. Exploiting the beneficial effect of glucose in regulating neuroinflammation and neuropathic pain, we hypothesize that the addition of glucose, as an adjuvant, to bupivacaine in the regional anesthesia technique for breast surgery could improve the quality of postoperative analgesia and prevent chronic pain after mastectomy. We hypothesize that the addition of glucose to bupivacaine could be superior to bupivacaine in ultrasound-guided SAPB in improving the quality of postoperative analgesia and preventing chronic pain after mastectomy. This randomized, double-blind study was designed to compare the efficacy and safety of co-administration of glucose and bupivacaine (study group), and bupivacaine alone (control group) in ultrasound-guided SAPB in patients undergoing modified radical mastectomy using the occurence of postmastectomy pain, 3 months after surgery, as the primary outcome.
- Conditions
- Post-mastectomy Pain Syndrome
- Being tested
- unilateral USG-deep SAPB with glucose, unilateral USG-deep SAPB without glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral USG-deep SAPB with glucoseProcedure or surgery
patients will receive unilateral USG-deep SAPB ; 15 ml 0.5 % isobaric bupivacaine with addition of 15ml glucose 10% to (30 ml total volume).
unilateral USG-deep SAPB without glucoseProcedure or surgery
will receive unilateral USG-deep SAPB; 15ml 0.5% isobaric bupivacaine to be diluted with 15ml isotonic saline0.9% (30 ml total volume).
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | will receive unilateral USG-deep SAPB ; 15 ml 0.5 % isobaric bupivacaine with addition of 15ml glucose 10% to (30 ml total volume). Receives: Procedure: unilateral USG-deep SAPB with glucose |
| Group Π | Active comparator | will receive unilateral USG-deep SAPB; 15ml 0.5% isobaric bupivacaine to be diluted with 15ml isotonic saline0.9% (30 ml total volume). Receives: Procedure: unilateral USG-deep SAPB without glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of chronic pain (post mastectomy pain syndrome)
The prevalence of chronic pain (post mastectomy pain syndrome) of any severity: Numerical pain scale (NRS) >0 on a 0 - 10 scale
Measured: 3 months after surgery
Secondary outcomes (4)
Numerical pain scale (NRS)
Numerical pain scale (NRS) on a 0 - 10 scale, o no pain, 10 worst pain
Measured: over 24 hours
Postoperative opioid consumption.
total consumption of morphine in the first 24 hours
Measured: over 24 hours
Patient satisfaction with pain management
Patient satisfaction with pain management assessed 24 h after surgery using an 11-point Likert scale (range, 0-10: 0, entirely unsatisfied; 10,fully satisfied).
Measured: 24 hours
The severity of CPSP and its impact on daily function
The severity of CPSP and its impact on daily function assessed 3 and 6 months after surgery using the revised brief pain inventory (BPI) Chinese-Simplified version
Measured: 3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start4 Jun 2024 (estimated)
- Primary completion4 Jun 2025 (estimated)
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-mastectomy Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohammed Alseoudy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443619
- Sponsor's protocol ID
- R.24.04.2582.
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Glucose Addition to Bupivacaine in Serratus Anterior Plane Block to Reduce the Occurrence of Chronic Post-mastectomy Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06443619
- Acronym / sponsor ID
- R.24.04.2582.
- Conditions
- Post-mastectomy Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 4 Jun 2024 (estimated)
- Primary completion
- 4 Jun 2025 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 5 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.
Nearly 50% of patients suffer from chronic pain following breast cancer surgery. Several regional anesthesia techniques, including paravertebral block, erector spinae plane block, pectoral nerves block, and serratus anterior plane block, have been applied for acute pain control and prevention of chronic pain after breast cancer surgery. Exploiting the beneficial effect of glucose in regulating neuroinflammation and neuropathic pain, we hypothesize that the addition of glucose to bupivacaine could be superior to bupivacaine in ultrasound-guided SAPB in improving the quality of postoperative analgesia and preventing chronic pain after mastectomy. Patients will be randomly allocated into one of two equal groups (30 patients each ); the study group; Group I( B-D) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25 % isobaric bupivacaine with addition of 15ml glucose 5% to (30 ml total volume); Group (B-N) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25% isobaric bupivacaine to be diluted with 15ml isotonic saline (30 ml total volume). The occurence of postmastectomy pain, 3 months after surgery, will be the primary outcome.
Detailed description
Breast cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related death in women. Although early detection and treatment have increased survival rates, chronic postsurgical pain (CPSP) is one of the most common complications of breast cancer surgery.
Nearly 50% of patients suffer from chronic pain following breast cancer surgery which is known as Post Mastectomy Pain Syndrome (PMPS). There are several risk factors for PMPS, including younger age, invasive surgical interventions, adjuvant radiation therapy following surgery, and high pain score in the early postoperative period. Several regional anesthesia (RA) techniques, including paravertebral block (PVB), pectoral nerves (PECS) block, and the erector spinae plane block (ESPB), have been applied for acute pain control and prevention of chronic pain after breast cancer surgery (BCS).
Recently, the serratus anterior plane block (SAPB) has become a newer interfacial plane block that appears to be safe and easily performed under ultrasound (de la Torre et al., 2014). A study concluded that preoperative SAPB with ropivacaine reduced the prevalence of CPSP at 3 months postoperativelyfrom 51.7% to 25.6%. Various adjuvants like fentanyl, clonidine, magnesium sulphate, nalbuphine, and dexamethasone have been used with bupivacaine in different blocks for prolonging the duration of analgesia and prevention of chronic pain. Using glucose 5% has been progressively applied to treat many peripheral entrapment neuropathies and has been proven to have outstanding effects in a few high-quality studies. Glucose 5% could decrease neurogenic inflammation by impeding the discharge of substance P and calcitonin gene-related peptides, which are pro-nociceptive substances that contribute to neurogenic inflammation and neuropathic pain. Exploiting the beneficial effect of glucose in regulating neuroinflammation and neuropathic pain, we hypothesize that the addition of glucose, as an adjuvant, to bupivacaine in the regional anesthesia technique for breast surgery could improve the quality of postoperative analgesia and prevent chronic pain after mastectomy. We hypothesize that the addition of glucose to bupivacaine could be superior to bupivacaine in ultrasound-guided SAPB in improving the quality of postoperative analgesia and preventing chronic pain after mastectomy. This randomized, double-blind study was designed to compare the efficacy and safety of co-administration of glucose and bupivacaine (study group), and bupivacaine alone (control group) in ultrasound-guided SAPB in patients undergoing modified radical mastectomy using the occurence of postmastectomy pain, 3 months after surgery, as the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: unilateral USG-deep SAPB with glucosewill receive unilateral USG-deep SAPB ; 15 ml 0.5 % isobaric bupivacaine with addition of 15ml glucose 10% to (30 ml total volume). |
| Group Π | Active comparator | Procedure: unilateral USG-deep SAPB without glucosewill receive unilateral USG-deep SAPB; 15ml 0.5% isobaric bupivacaine to be diluted with 15ml isotonic saline0.9% (30 ml total volume). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status I-II
- age ranging from 20 to 60 years
- scheduled for unilateral modified radical mastectomy
Key exclusion criteria (7 listed)
- patient refusal to participate in the study
- infection at site of needle insertion
- hypersensitivity to the studied drugs
- psychotic disorders,
- bilateral MRM ,
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 |
|---|---|---|
| unilateral USG-deep SAPB with glucosepatients will receive unilateral USG-deep SAPB ; 15 ml 0.5 % isobaric bupivacaine with addition of 15ml glucose 10% to (30 ml total volume). | Procedure or surgery | Group I |
| unilateral USG-deep SAPB without glucosewill receive unilateral USG-deep SAPB; 15ml 0.5% isobaric bupivacaine to be diluted with 15ml isotonic saline0.9% (30 ml total volume). | Procedure or surgery | Group Π |
Primary outcome
The prevalence of chronic pain (post mastectomy pain syndrome)
Time frame: 3 months after surgery
The prevalence of chronic pain (post mastectomy pain syndrome) of any severity: Numerical pain scale (NRS) >0 on a 0 - 10 scale
4 secondary outcomes
Numerical pain scale (NRS)
Time frame: over 24 hours
Postoperative opioid consumption.
Time frame: over 24 hours
Patient satisfaction with pain management
Time frame: 24 hours
The severity of CPSP and its impact on daily function
Time frame: 3 and 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral USG-deep SAPB with glucose and unilateral USG-deep SAPB without glucose in people with Post-mastectomy Pain Syndrome, run by Mansoura 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 3 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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. 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. 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?
Results are not available in the source record.
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?
The prevalence of chronic pain (post mastectomy pain syndrome) (time frame: 3 months 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 5 Jun 2024.