An interventional study of Bupivacaine 0.25% Injectable Solution in Breast Cancer, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
Among 22 studies testing bupivacaine in Breast Neoplasms — none open to participants now, 1 under way, 1 of them phase 3. Bupivacaine · Breast Neoplasms.
Among the 22 studies testing bupivacaine in Breast Neoplasms, this one is the 7th largest by enrollment, is one of 2 that started in 2023, is one of 6 with no phase, and was the 22nd registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 70 is close to the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →None of the 22 studies testing bupivacaine in Breast Neoplasms is open now.
Bupivacaine: first FDA approval 1972 (MARCAINE HYDROCHLORIDE PRESERVATIVE FREE), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 20 Years to 60 Years · female · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2023.
Median enrollment 60 across the 22 interventional studies. Of the 15 that completed or were terminated, 6 (40%) have results posted.
None of the 22 has an industry lead sponsor. The 10 most frequent:
Beni-Suef University is the lead sponsor of 349 studies on the registry; 125 are open to participants now.
Beni-Suef University has 8 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies testing bupivacaine in Breast Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03351348Phase 3Memorial Sloan Kettering Cancer CenterBupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control | 2027-11 |
Among the 22 studies testing bupivacaine in Breast Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
Regional/local analgesic techniques are an important component of a multimodal analgesic strategy, with the aim of reducing opioid requirements and opioid-related adverse events. This change parallels quality improvement initiatives and the Enhanced Recover after Surgery.
Breast conserving surgery with radiation therapy is today standard therapy for low grade breast cancer. It is safe and preferred therapeutic procedure in all early detected breast cancers ,because it provide the same level of overall survival rates as seen in patients treated with mastectomy ,have been found by several prospective and randomized studies and number of clinical trials .
Acute post-surgical pain leads to delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay.
It is also an important factor leading to the development of chronic persistent post-operative pain in almost half of the patients. Post-operative pain, stress and use of morphine have been elucidated as factors responsible for increased risk of metastasis.
Hence, an effective perioperative pain management of patients undergoing breast surgery is essential. Regional blocks have been considered as one of the modalities for effective perioperative pain control. They have an opioid-sparing effect, and allow early mobilisation and early discharge from hospital.
Ultrasound-guided muscle plane blocks have changed the practice of regional anesthesia for breast surgeries. Different variations of Pecs block have been described with an aim to provide anesthesia and analgesia of the hemi thorax.
Recently described serratus anterior plane (SAP) block was designed to target primarily the thoracic intercostal nerves, providing complete analgesia to the lateral part of the thorax. Compared with Pecs-II, the needle is placed more caudally and posteriorly in SAP block and local anesthetic (LA) is deposited either superficial or deep to the serratus anterior muscle.
Serratus Anterior Plane (SAP) block has been described recently as injection of local Anesthetic (LA) in mid axillary line at the level of the 5th rib either superficial or deep to the serratus anterior (SA) muscle. The intention is to block the thoracic intercostal nerves to provide complete analgesia of the lateral part of the chest.
There are some clinical reports validating its use in breast surgeries. Although serratus anterior plane (SAP) block affects the long thoracic nerve of bell supplying serratus anterior (SA) but there is no mention of blocking the thoracodorsal nerve supplying latissmus dorsi (LD).The thoracodorsal nerve is the sole nerve that supplies latissmus dorsi (LD) and forms a plexus between serratus anterior (SA)and latissmus dorsi (LD).
On the other hand, regarding thoracic epidural analgesia, the results from MRI studies indicate that the spinal cord lies anteriorly within its thecal sac in the thoracic curve and the following measures were found: 5.19 mm in T2, 7.75 mm in T5 and 5.88 mm in T10, this let us say, sufficient distance to permit the careful advancement of a needle (accidentally or intentionally) without reaching the cord and administer anesthetic for a segmental spinal anesthesia. This anatomical explanation was proposed for the absence of spinal cord injury during an accidental perforation during attempted thoracic epidural.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
About 35 female patients diagnosed with breast malignancy subjected to Breast Conservative Surgery under general anesthesia by Ultrasound guided serratus anterior plane block anesthesia
Drug: Bupivacaine 0.25% Injectable Solution
About 35 female patients diagnosed with breast malignancy subjected to Breast Conservative Surgery under general anesthesia by ultrasound guided Thoracic Epidural Analgesia
Drug: Bupivacaine 0.25% Injectable Solution
to compare and evaluate safety, efficacy, benefits and complications of thoracic epidural analgesia and serratus anterior plane block in patients undergoing Conservative breast surgery under general anesthesia.
Also known as: fentanyl
Post Operative Pain
the duration of effective analgesia from the block till the first analgesic dose is required.the severity of postoperative pain as assessed by the visual analogue scale ((0 = no pain, 10 = most imaginable pain) at 1, 4, 8, 12, and 24 hours after the completion of the surgery.
Time frame: from 2 hous till 24 hours after the surgery
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine