Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04750512 |
| Other study ID # |
ORBV - CHIR - TAPESP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 11, 2021 |
| Est. completion date |
May 31, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Ente Ospedaliero Cantonale, Bellinzona |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Erectore Spinae Plane Block (ESP Block) is a recently described technique for regional
anesthesia that has shown promising results in the treatment of pain after thoracic surgery.
It involves the injection of local anesthetic behind the musculature of the back.
The investigators intend to compare this technique with a more standardized one, the TAP
Block, which involves injection of anesthetic behind the musculature of the abdomen.
50 patients undergoing robotic inguinal hernia repair under general anesthesia will be
randomly selected to receive, in addition to general anesthesia, either the ESP block or the
TAP block. Patients receiving an ESP Block will also receive an injection of saline solution
in the TAP injection site, and the other way around. This will prevent preconceived ideas on
either technique to influence the evaluationso of the effect.
Pain scores and consumption of pain medication will be recorded during the 24 hours following
the operation to compare the effect of the two techniques.
Description:
In the recent era of increased awareness towards the risks and complications of opioid
treatment, pain management after common surgical interventions by the means of regional
anesthesia is of renewed interest for both clinical and logistic reasons, as it is known that
good pain management reduces complications and cost associated to surgery.
Regional and local anesthetic techniques after inguinal hernia surgery have been the topic of
multiple studies, comparing various infiltrative methods, including wound infiltration, port
site infiltration, iliohypogastric and ilioinguinal nerve block, paravertebral and
transversus abdominis plane (TAP) block and epidural analgesia. Most methods investigate pain
treatment in the setting of open surgery. The progressive evolution towards laparoscopic and
robot-assisted methods changes the mechanisms of surgical pain and, with it, the rational for
the choice of the analgesic technique adopted. The transversus abdominis plane (TAP) has
become a widely used technique and has been demonstrated to be associated to a mild opioid
sparing effect, but with inconsistent results.
The erector spinae plane block is a promising technique, recently described and used
especially in thoracic surgery. Multiple case reports and studies in pediatrics report it to
be a safe and effective method for abdominal surgery as well, but no prospective randomized
trials were published to date in the adult population, particularly with regard to
laparoscopic or robotic hernia repair. A prospective comparison between the two techniques is
therefore needed in this specific context.
Hypothesis and primary objective:
The investigators hypothesize the superiority of the ESP-block to the TAP-block with respect
to post-operative pain control after abdominal surgery, leading to a reduction in reserve
analgesic consumption.
Our objective is to compare the clinical outcomes and safety of ESP block versus TAP block in
patients undergoing robot-assisted TAPP inguinal hernia repair.
Primary and secondary endpoints:
Primary Endpoint:
- The highest VAS score reported between end of sedation and 6 hours after surgery or
discharge of the patient, whichever comes first Secondary Endpoints
- Time to first rescue analgesic
- Total dose of rescue opioids (morphine equiavalents) in the first 24 hours after surgery
- Time of first walk after surgery
- Need for anti-nausea medication (dosage, doses and time points)
- Episodes of vomiting
- Episodes of urinary retention
- Patient's satisfaction (measured on the validated LPPS questionnaire for the
perioperative patients' satisfaction )
- Length of hospital stay
Study design This is a single center, prospective, randomized, placebo-blinded, controlled
superiority trial in 2 parallel arms comparing the efficacy and safety of the ESP Block and
the TAP block on patients undergoing elective robot-assisted inguinal hernia repair.
Follow up will consist in the hospitalization period plus one telephone consultation at 24
hours after hospitalization.
Methods of minimizing bias:
Randomisation - Patients will be randomized in a 1:1 ratio by a computer generated random
number sequence through the RedCap software system.
Blinding procedures
According to the randomization arm patients will receive:
- sham US-guided ESP block + US-guided TAP block before laparoscopic hernia repair
- US-guided ESP block + sham US-guided TAP block before laparoscopic hernia repair
Allocation will take place immediately before the intervention by the means of access to
centralized, real-time allocation through a computer program.
Personnel not directly involved with patient care will prepare a saline solution and a
ropivacaine solution which will be allocated respectively to ESP or TAP block according to
randomization.
This will allow blinding of patients, care providers and data collectors. Analysis will be
done on allocation-concealed data, permitting blinded analysis.
Unbliding will be permitted if by doing so harm to one or more patients can be avoided or
treated. After information of one of the principal investigators, specific patient allocation
will be retrieved from the randomization program.
Other methods of minimising bias
Pain scores will be measured at 1, 3, 6, 12 and 24 hours after extubation and at the time of
administration of reserve analgesics.
The administration of reserve analgesics will follow a standardized internal protocol.
Questionnaires validated to assess functional results after hernia surgery will be used for
this study:
- pain: Visual Analogue Scale (VAS)
- surgical complications classification: Clavien Dindo's classification
- comorbidities : American Society of Anesthesiology (ASA) score
- validated LPPS questionnaire for the perioperative patients' satisfaction [21]
- EHS inguinal hernia classification
