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Phase 4 N=100 Randomized Single-blind Treatment

Serratus Plane Versus Paravertebral Nerve Blocks for Breast Surgery

Breast Surgery

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Mean/Median Numeric Rating Scale Pain Score Within the Recovery Room — 4; 0 score on a scale — p=0.001

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Serratus Plane block (single injection) (Drug); Paravertebral block (single injection) (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of California, San Diego
Primary completion
Feb 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean/Median Numeric Rating Scale Pain Score Within the Recovery Room
4; 0 0.001 sig
PRIMARY
Mean/Median Opioid Consumption Within the Recovery Room
14; 10
SECONDARY
Number of Participants Requiring an Anti-emetic Within the Recovery Room
19; 8
SECONDARY
Opioid Consumption After Recovery Room Discharge
2; 2
SECONDARY
WORST Pain Measured Using the Numeric Rating Scale Pain Score
5; 3
SECONDARY
Lowest Pain Measured Using the Numeric Rating Scale Pain Score
1; 0
SECONDARY
Average Pain Measured Using the Numeric Rating Scale Pain Score
3; 2
SECONDARY
Worst RECOVERY ROOM Pain Measured Using the Numeric Rating Scale Pain Score
5; 3
SECONDARY
Awakenings Due to Pain
0; 0
SECONDARY
LEAST RECOVERY ROOM Pain Measured Using the Numeric Rating Scale Pain Score
0; 0
SECONDARY
Opioid Consumption Within the Operating Room
10; 10
SECONDARY
Nausea and Vomiting Following Recovery Room Discharge
0; 0
SECONDARY
Time From Recovery Room Discharge Until First Opioid Use
14; 8
SECONDARY
Time From Recovery Room Discharge Until Block Resolution
SECONDARY
WORST Pain Measured DURING NERVE BLOCK Using the Numeric Rating Scale Pain Score
2; 1
SECONDARY
Average Pain Measured DURING NERVE BLOCK Using the Numeric Rating Scale Pain Score
1; 1
SECONDARY
Time to Perform Nerve Block
1.25; 4

Summary

Following painful surgical procedures of the breast, postoperative analgesia is often provided with a paravertebral nerve block (PVB). For intense, but shorter-duration acute pain, a single-injection of local anesthetic is used with a duration of approximately 12 hours. Recently an alternative block has been reported: the serratus plane block.2 The theoretical benefits include ease of administration since it is a plane superficial to the PVB and therefore easier to identify and target with ultrasound (therefore increasing success rate); and an increased safety margin as there are fewer anatomic structures in the immediate area which could be injured with the needle; and, the target plane is much further from the intrathecal/epidural space relative to the PVB, therefore leakage of cerebrospinal fluid or injury to the spinal cord are less likely with the serratus compared to the PVB.3 There are, therefore, multiple theoretical reasons to prefer the serratus over the PVB. Unfortunately, it remains unknown if the analgesia provided by this new technique is comparable to that provided with the PVB.4 The investigators therefore propose to compare these two techniques with a randomized, subject-masked, active-controlled, parallel-arm clinical trial.

Eligibility Criteria

Inclusion Criteria

  • undergoing unilateral or bilateral breast surgery with at least moderate postoperative pain anticipated
  • analgesic plan includes a single-injection peripheral nerve block(s)
  • age 18 years or older

Exclusion Criteria

  • morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2)
  • renal insufficiency (preoperative creatinine > 1.5 mg/dL)
  • chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
  • history of opioid abuse
  • any comorbidity which results in moderate or severe functional limitation inability to communicate with the investigators or hospital staff
  • pregnancy
  • planned regional analgesic with perineural catheter placement
  • incarceration
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03860974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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