Anesthesia Clinical Trial
Official title:
Single-shot Pectoral Plane (PECs) Blocks Versus Continuous Local Anaesthetic Infusion Analgesia or Both PECs Block and Local Anaesthetic Infusion After Non-ambulatory Breast Cancer Surgery: A Prospective, Randomised, Double-blind Trial
In this proposed study, the investigators are looking to conduct a prospective, randomised,
double-blind, non-inferiority trial, to study single-shot pectoral plane (PECs) blocks versus
continuous local anaesthetic infusion analgesia versus a combination of PECs blocks and local
anaesthetic infusion analgesia, when it comes to providing analgesia for most forms of breast
surgery.
Breast surgery is common, and the optimal form of analgesia is currently unknown. Techniques
involving local anaesthetic, such as pectoral plane (PECs) blocks and infusion pumps, are
growing in popularity, as they reduce the amount of opioid medications used. Opioids are
associated with nausea, vomiting, low blood pressure, drowsiness and constipation, and as
such, opioid-sparing analgesic regimens postoperatively are becoming more common. These
regimens will typically involve paracetamol, a NSAID (non-steroidal anti-inflammatory drug),
and a local anaesthetic technique.
Pectoral plane blocks involve a once-off injection of local anaesthetic at two locations
within the chest wall, typically done after the patient undergoes general anaesthesia, but
before the commencement of surgery. Local anaesthetic infusion pumps involve the insertion of
a catheter into the wound at the end of surgery, before the patient emerges from general
anaesthesia, that constantly emit local anaesthetic over a defined period of time. Each
technique is considered extremely safe, and is considered acceptable as a form of pain relief
in patients undergoing breast surgery.
There are no published works comparing pectoral plane blocks with local anaesthetic infusion
pump analgesia, and the investigators see a gap in the knowledge base that can be addressed.
This study will allow efficacy, safety and cost of the three techniques to be compared. The
investigators feel the study design is robust, and statistical analysis based on previously
published works in the area of postoperative analgesia has allowed the study to be powered
appropriately.
Patients undergoing breast surgery are a vulnerable group, and this is recognised via the
provision of a comprehensive Patient Information Leaflet and a commitment to respecting the
process of Informed Consent. The investigators also recognise this is a stressful period in a
woman's life, and the study will be conducted in a sensitive and compassionate manner.
The study has been designed to be prospective, randomised, and double-blinded. The
anaesthetic will be standardised in relation to analgesic and anti-emetic agents
administered, in order to minimise variables. Chronic post-surgical pain is a growing area of
research, and the follow-up telephone interview at 3-months will allow investigation of this.
A Data Record Form will be utilised for data collection, which will subsequently be analysed
statistically. Data will be handled sensitively, securely, and by the minimum number of
researchers. A plan is in place for destruction of data at an appropriate time.
While there will be no direct benefit to participants, including monetary considerations,
this research study will add to the knowledge-base surrounding analgesia for breast surgery.
Methods The Mater Misericordiae University Hospital's Institutional Review Board (IRB)
approved this study; reference number 1/378/1840, dated December 21st, 2016. It was
registered with clinicaltrials.gov; reference number NCT03024697, dated February 15th, 2017.
Forty-five ASA I-III female patients aged 18 years or older, undergoing non-ambulatory breast
cancer surgery under general anaesthesia between January and May 2017 were included. All
participants provided informed written consent.
Non-ambulatory breast cancer surgery encompassed wide-local excision with lymph node
resection, simple mastectomy, and mastectomy with lymph node resection. Those undergoing
latissimus dorsi or DIEP (deep inferior epigastric perforator) flap reconstruction were
excluded. Patients with chronic pain syndromes, local anaesthetic allergy, contraindication
to simple analgesics, local infection over the proposed block site, coagulopathy, or
co-morbid conditions precluding the provision of informed consent, were excluded. All
patients were day of surgery admission and attended a preoperative anaesthetic assessment
clinic.
Patients were allocated into three groups using computer-generated randomisation, with the
study number and group allocation concealed in sealed envelopes. Blocked randomisation in
groups of 9 was applied, giving similar numbers in each group as the study progressed. Groups
were named 'PECs', 'Local anaesthetic infusion (LA infusion)' , and 'Both (PECS & LA
infusion)', which were evenly distributed to opaque envelopes numbered one to forty-five in
accordance with randomisation. The randomisation key was held by an independent party, and
was not used to reveal participant group allocations until data analysis commenced. 'PECs'
patients received PECS I & II blocks and a sham wound infiltration catheter. 'LA infusion'
patients received a continuous local anaesthetic wound infusion catheter. 'PECs & LA
infusion' patients received a combination of techniques, without the initial local
anaesthetic bolus via the wound infusion catheter. PECs blocks were performed while patients
were under general anaesthesia, prior to the commencement of surgery. The operative surgeon
sited wound infusion catheters during skin closure at the end of surgery.
Patients were induced with fentanyl 1-2 μg.kg-1, followed by propofol titrated to the absence
of verbal response. Anaesthesia was maintained using an oxygen, air and sevoflurane
combination. Airway management and lung ventilation strategies were at the discretion of the
supervising anaesthetist. Patients received a standard intraoperative analgesic regimen of
paracetamol 1g and dexketoprofen 50mg intravenously (IV), with rescue morphine as deemed
necessary. Combination antiemetics, including ondansetron 0.1-0.15 mg.kg-1 IV, dexamethasone
0.1-0.2 mg.kg-1 IV or droperidol 0.01-0.015 mg.kg-1 IV, were administered according to
patient risk factors. Intraoperative management was otherwise left to the discretion of the
supervising anaesthetist. Routine monitoring was used in accordance with AAGBI guidelines15.
An electronic anaesthetic record was used to document physiological parameters. Perioperative
events, such as induction of anaesthesia, initial skin incision, and end of surgery, were
annotated on the record.
PECs I & II blocks were performed on the side of surgery, using the ultrasound-guided
technique described by Blanco et al9, 10. The patient was placed in the supine, head-up,
position with the arm abducted. The skin was prepared with chlorhexidine gluconate
2%/isopropyl alcohol 70% (BD, ChloraPrep, NJ, USA). PECs blocks were performed with a
22-gauge echogenic needle (B. Braun, Ultraplex 360 cannula, Hessen, Germany; 50-80mm), using
the same ultrasound machine (Sonosite Edge, Sonosite, Inc., Bothwell, WA, USA) and transducer
(Sonosite HFL 50x, Sonosite, Inc., Bothwell, WA, USA). The ultrasound probe was placed
inferolaterally at the mid-clavicular level. The axillary artery and vein were identified,
and the probe moved laterally until pectoralis major, pectoralis minor and serratus anterior
muscles were located at the level of the 3rd rib. A needle in-plane approach was taken until
the needle tip was positioned in the plane between pectoralis major and minor muscles, and
levobupivacaine 0.25% 10ml was injected. The needle was advanced until it occupied the space
between pectoralis minor and serratus anterior muscles, and a further 20ml of levobupivacaine
0.25% was injected.
Blinding was not considered necessary for 'LA infusion' group patients, as PECs blocks were
performed under general anaesthesia. All patients had a wound infusion catheter sited and
attached to an elastometric pump (B. Braun, ON-Q PainBuster, Hessen, Germany), which was
placed by the operating surgeon during skin closure at the end of surgery. For blinding
purposes, patients in the 'PECs' group received a sham wound infiltration catheter system.
'LA infusion' and 'PECS & LA infusion' patients received levobupivacaine 0.1% at 10ml.hr-1
for 24 hours postoperatively, while 'PECs' patients received sodium chloride 0.9% at the same
rate. 'LA infusion' patients were administered an initial bolus of levobupivacaine 0.25% 20ml
at the end of surgery. Those who performed the procedures, or were involved in the
perioperative management, were not involved in postoperative pain assessment or data
collection. Study interventions as described occurred while patients were under general
anaesthesia.
Patients were monitored for 24 hours after surgery, initially in the post-anaesthesia care
unit (PACU), and then at ward level once PACU discharge criteria were met. Oxycodone 1-2mg IV
as required was prescribed for rescue analgesia in the PACU. A standard analgesic protocol of
paracetamol 1g PO/IV 6-hourly regular, ibuprofen 400mg PO 8-hourly regular, and oxycodone
immediate release (oxynorm) 5-10mg 1-hourly as required for rescue analgesia, was prescribed
for all patients. Ondansetron 4-8mg IV 8-hourly as required was prescribed, to be
administered in the event of postoperative nausea and vomiting (PONV).
The primary outcome measure of the study was area under curve of verbal rating score (VRS) of
pain moving versus time, (AUC) where VRS pain was measured at 1 hour, 4-6 hours, 10-14 hours,
and 20-24 hours postoperatively. At each assessment, patients were invited to report their
pain VRS pain at rest. Pain while moving was defined as pain experienced while sitting
forward from a recumbent position. Secondary outcome measures were total opioid consumption
over a 24-hour period and presence of adverse events. An investigator masked to group
allocations recorded vital signs, pain scores, antiemetic administration and opioid use
postoperatively. Adverse events such as sedation, respiratory depression, hypotension,
pruritus and PONV were also recorded.
Statistical Analysis
Data was analysed by Graph Pad Prism v6 (Salt Lake City, UH). The primary end-point was area
under the VRS moving versus time curve (AUC). We powered the study to detect a 25% difference
in AUC from an internal pilot study which indicated mean AUC of 60 cm.hr-1 (SD 5-10) among
patients receiving PECs or LA infusion in our clinical service, to 45 cm.hr-1. We had
observed the standard deviation of the AUC to be in the order of 15 cm.hr-1. Assuming a Type
I error of 0.05 and a Type II error of 0.1, then n=11 patients would be required each group
to detect this difference with 90% power. We obtained IRB permission for n=15 each group to
allow for protocol violations or patient drop-out.
Data was collected at 1, 4-6, 12-14 and 20-24 hr, post-operatively. It was tested for
distribution initially using the Kolmogorov-Smirnov test. For each patient, their AUC both
moving and at rest was calculated by plotting their pain VRS versus time using Graph Pad
Prism v.6. The mean AUC according to the three study groups was then calculated and inspected
for distribution as described above, and all AUC data was found to be normally distributed.
Therefore, AUC data is expressed as mean ± SD and was compared using ANOVA with post hoc
Bonferroni correction. Non-normally distributed data was compared using the Kruskal-Wallis
test for repeated measurements. Categorical data (e.g. the incidence of potential adverse
effects) were compared using Fischer's exact test where appropriate. P<0.05 was deemed
statistically significant.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04279054 -
Decreased Neuraxial Morphine After Cesarean Delivery
|
Early Phase 1 | |
Active, not recruiting |
NCT04580030 -
Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
|
||
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Recruiting |
NCT04099693 -
A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
|
||
Terminated |
NCT02481999 -
Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
|
||
Completed |
NCT04235894 -
An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
|
||
Recruiting |
NCT05525104 -
The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).
|
N/A | |
Recruiting |
NCT05024084 -
Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth
|
Phase 4 | |
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03277872 -
NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope
|
N/A | |
Terminated |
NCT03940651 -
Cardiac and Renal Biomarkers in Arthroplasty Surgery
|
Phase 4 | |
Terminated |
NCT02529696 -
Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Terminated |
NCT03704285 -
Development of pk/pd Model of Propofol in Patients With Severe Burns
|
||
Recruiting |
NCT05259787 -
EP Intravenous Anesthesia in Hysteroscopy
|
Phase 4 | |
Completed |
NCT02894996 -
Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?
|
N/A | |
Completed |
NCT05386082 -
Anesthesia Core Quality Metrics Consensus Delphi Study
|
||
Terminated |
NCT03567928 -
Laryngeal Mask in Upper Gastrointestinal Procedures
|
N/A | |
Recruiting |
NCT06074471 -
Motor Sparing Supraclavicular Block
|
N/A | |
Completed |
NCT04163848 -
CARbon Impact of aNesthesic Gas
|