Clinical trial NCT05448638: Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block for Breast Cancer Surgery
Official title: Quality of Recovery Scores in Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block Versus Pectoral Nerves Block for Breast Cancer Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, controlled trial for evaluating the efficacy of addition of transversus thoracic muscle plane block to pectoral nerves block versus pectoral nerves block for quality of recovery scores in breast cancer surgery.

Detailed description: The pectoral nerves (PECS) block cannot block the most internal mammary region, whereas a transversus thoracic muscle plane (TTP) block can. The combination of PECS and TTP blocks may be suitable for breast cancer surgery. We studied patients undergoing breast cancer surgery to assess whether the combination of PECS and TTP blocks provides better postoperative recovery than PECS block alone.

Eligibility criteria: Inclusion Criteria:

* female, 18-80 years of age
* American Society of Anesthesiologists physical status I-III
* patients having elective unilateral breast cancer surgery

Exclusion Criteria:

* contraindication to nerve block
* inability to understand or communicate with research personnel
* chronic use of opioids or nonsteroidal anti-inflammatory drugs
* pregnancy

Primary outcomes:
measure: the quality of recovery-15 questionnaire (QoR-15)
timeFrame: at 24 hours after surgery
Secondary outcomes:
measure: NRS score for rest and coughing pain
timeFrame: at 1, 6, 24, 48 hours after surgery
measure: consumption of opioid converted to IV morphine equivalents
timeFrame: during 24 hours after surgery
measure: the incidence of postoperative hypotension
timeFrame: during 48 hours after surgery
measure: the incidence of nausea and vomiting
timeFrame: during 48 hours after surgery
measure: the incidence of pruritus
timeFrame: during 48 hours after surgery
measure: the incidence of respiratory depression
timeFrame: during 48 hours after surgery
measure: time to urethral catheter removal in hours
timeFrame: through study completion, an average of 24-36 hours
measure: postoperative hospital stay in days
timeFrame: through study completion, an average of 5-7 days
measure: intra-operative opioid requirements
timeFrame: through the anesthesia process, an average of 1.5-2.5h
measure: the block-related outcomes
timeFrame: through study completion, an average of 5-7 days
measure: the Brief Pain Inventory
timeFrame: at 3 months after surgery.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Huifang Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: