Trials / Unknown
UnknownNCT02719795
Pectoral Nerves Blocks for Chronic Pain
Pectoral Nerves Blocks and Their Effect on Chronic Pain After Breast Cancer Surgery
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether pectoral nerves blocks(PECS) would reduce chronic pain at 3 months after modified radical mastectomy(MRM)surgery.
Detailed description
One hundred and forty adult female participants scheduled for elective unilateral modified radical mastectomy under general anesthesia are randomly allocated to receive either general anesthesia plus Pecs block(Pecs group, n=70) or general anesthesia alone (control group, n=70). After arrived in the operating room,the participants in the control group are accepted the general anesthesia.Whereas,after anesthesia induction,the participants in the Pecs group receive an ultrasound-guided Pecs block and a 15 minute observation time prior before the start of the operation. Pecs block technology: A broadband (5-12 hertz) linear array probe of Sonosite Edge portable ultrasound system (Sonosite Inc,Bethel,Washington) is used, with an imaging depth of 4 to 6 cm. After cleaning the infraclavicular and axillary regions with chlorhexidine, the probe is placed below the lateral third of the clavicle, similar to what is done when performing infraclavicular brachial plexus block. After recognition of the appropriate anatomical structures, the skin puncture point is infiltrated with 2% lignocaine, then the block is performed by using a 20-gauge Tuohy needle. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.35% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib below the serratus anterior muscle with the intent of spreading injectate to the axilla.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ropivacaine | Local injection of local anesthetic into the fascial spaces |
| DRUG | Normal saline | Sodium chloride solution commonly used in clinical which equal to human plasma osmotic pressure. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2018-12-01
- Completion
- 2019-02-01
- First posted
- 2016-03-25
- Last updated
- 2017-02-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02719795. Inclusion in this directory is not an endorsement.