Trial Outcomes & Findings for Reducing Pain and Disability After Breast Cancer Surgery (NCT NCT01089933)

NCT ID: NCT01089933

Last Updated: 2025-04-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 129 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2025-04-04

Participant Flow

Participant milestones

Measure	Thoracic PVB + Multimodal Anesthesia Thoracic PVB + multimodal anesthesia Thoracic Paravertebral Block (TPVB): The middle of the spinous process above the nerve to be blocked is located and the overlying skin marked 2.5 centimeters lateral to this. Subcutaneous lidocaine is injected and a 22 G Tuohy tipped 8 cm needle is inserted at this level and advanced to identify the transverse process. The needle is then moved caudad off the transverse process and inserted a centimeter into the paravertebral space. Five mls of 0.5% ropivacaine with 1:200,000 epinephrine is injected at each paravertebral space. Blocks adjacent to the C7-T5 spinous processes are performed. For patients randomized to the LA group: The patients are identically positioned, sedated and identical landmarks are used to perform sham paravertebral blocks via a subcutaneous saline injection of 0.5mL with a 25G needle at each level.	Local Anesthetic + Multi-modal Analgesia Local anesthetic + multi-modal analgesia Local Anesthetic: At the conclusion of surgery, the surgeon will infiltrate the incision with 10 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group). An axillary drain will be placed. After closure of the wound, 20 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group) will be injected through the drain and the drain clamped for 30 minutes after injection.
Overall Study STARTED	65	64
Overall Study COMPLETED	65	64
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Thoracic PVB + Multimodal Anesthesia n=65 Participants Thoracic PVB + multimodal anesthesia Thoracic Paravertebral Block (TPVB): The middle of the spinous process above the nerve to be blocked is located and the overlying skin marked 2.5 centimeters lateral to this. Subcutaneous lidocaine is injected and a 22 G Tuohy tipped 8 cm needle is inserted at this level and advanced to identify the transverse process. The needle is then moved caudad off the transverse process and inserted a centimeter into the paravertebral space. Five mls of 0.5% ropivacaine with 1:200,000 epinephrine is injected at each paravertebral space. Blocks adjacent to the C7-T5 spinous processes are performed. For patients randomized to the LA group: The patients are identically positioned, sedated and identical landmarks are used to perform sham paravertebral blocks via a subcutaneous saline injection of 0.5mL with a 25G needle at each level.	Local Anesthetic + Multi-modal Analgesia n=64 Participants Local anesthetic + multi-modal analgesia Local Anesthetic: At the conclusion of surgery, the surgeon will infiltrate the incision with 10 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group). An axillary drain will be placed. After closure of the wound, 20 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group) will be injected through the drain and the drain clamped for 30 minutes after injection.	Total n=129 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=65 Participants	0 Participants n=64 Participants	0 Participants n=129 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=65 Participants	64 Participants n=64 Participants	129 Participants n=129 Participants
Age, Categorical >=65 years	0 Participants n=65 Participants	0 Participants n=64 Participants	0 Participants n=129 Participants
Age, Continuous	54 years STANDARD_DEVIATION 10.8 • n=65 Participants	56 years STANDARD_DEVIATION 10.6 • n=64 Participants	55 years STANDARD_DEVIATION 10.7 • n=129 Participants
Sex: Female, Male Female	65 Participants n=65 Participants	64 Participants n=64 Participants	129 Participants n=129 Participants
Sex: Female, Male Male	0 Participants n=65 Participants	0 Participants n=64 Participants	0 Participants n=129 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	65 participants n=65 Participants	64 participants n=64 Participants	129 participants n=129 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	Thoracic PVB + Multimodal Anesthesia n=65 Participants Thoracic PVB + multimodal anesthesia Thoracic Paravertebral Block (TPVB): The middle of the spinous process above the nerve to be blocked is located and the overlying skin marked 2.5 centimeters lateral to this. Subcutaneous lidocaine is injected and a 22 G Tuohy tipped 8 cm needle is inserted at this level and advanced to identify the transverse process. The needle is then moved caudad off the transverse process and inserted a centimeter into the paravertebral space. Five mls of 0.5% ropivacaine with 1:200,000 epinephrine is injected at each paravertebral space. Blocks adjacent to the C7-T5 spinous processes are performed. For patients randomized to the LA group: The patients are identically positioned, sedated and identical landmarks are used to perform sham paravertebral blocks via a subcutaneous saline injection of 0.5mL with a 25G needle at each level.	Local Anesthetic + Multi-modal Analgesia n=64 Participants Local anesthetic + multi-modal analgesia Local Anesthetic: At the conclusion of surgery, the surgeon will infiltrate the incision with 10 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group). An axillary drain will be placed. After closure of the wound, 20 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group) will be injected through the drain and the drain clamped for 30 minutes after injection.
The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection.	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 year

Brief Pain Inventory (BPI); Flexion, extension, abduction, internal, and external rotation of the shoulder; Constant score; Quality of life was assessed using the FACTB4 and the SF-12 Health Survey (SF12); Details of the surgery, chemotherapy, and/or radiation therapy were recorded

Outcome measures

Outcome data not reported

Adverse Events

Thoracic PVB + Multimodal Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Local Anesthetic + Multi-modal Analgesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Michelle Chiu

OHRI

Phone: 613-798-5555

Email: mchiu@toh.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place