Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06155253 |
| Other study ID # |
CIRB-2023-091-2 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2023 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Hospital Authority, Hong Kong |
| Contact |
Ip |
| Phone |
2468 5111 |
| Email |
pky.ip[@]ha.org.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to compare the effects of single-level and bi-level
erector spinae plane block in open inguinal hernia repair surgery. The main question it aims
to answer are:
- Whether bi-level ESP block will improve pain control after open inguinal hernia repair
surgery
- Whether bi-level ESP block will improve quality of recovery after open inguinal hernia
repair surgery
Participants will receive erector spinae plane block, and will be randomised into 2 groups,
single-level ESP block and bi-level ESP block, before open hernia repair surgery. They will
be followed up after operation for assessment of pain control and quality of recovery.
Description:
Open inguinal hernia repair is increasingly performed as a day case surgery. As a result,
satisfactory acute pain control is very important to reduce discomfort, as well as to
facilitate early mobilisation and recovery. Regional anaesthesia, eg. erector spinae plane
block (injection below para-spinal muscles) is increasingly implemented as part of
multi-modal analgesia to establish better post-operative pain control and spare the use of
opioids which can lead to unwanted side effects eg. sedation, nausea and vomiting. Acute
post-surgical pain from open inguinal hernia repair consists of subcutaneous, deep somatic
and visceral components. The erector spinae plane (ESP) block acts by local anaesthetic (LA)
spread to ventral and dorsal rami of spinal nerves, producing somatic and visceral pain
relief. Therefore, it can effectively relieve acute post-surgical pain resulted from open
hernia repair. Bi-level ESP block has been utilised clinically to provide multi-dermatomal
analgesia in pain management eg. flail chest; or anaesthetic management eg. open inguinal
hernia repair, scoliosis surgery, mastectomy. However, to date, there have been no studies
comparing the analgesic efficacy of bi-level and single-level erector spinae plane blocks.
The investigators postulate that comparing with single-level ESP block, bi-level ESP block
can facilitate LA spread into paraspinal areas more effectively, producing more reliable
analgesia; and therefore would reduce post-operative pain scores and improve quality of
recovery in patients undergoing open inguinal hernia repair.
To investigate the above clinical question, a parallel-group observer-blinded randomised
clinical trial was designed. Patients will be randomised into 2 groups. One group of patients
(2ESP) will receive ESP block at ipsilateral T12 and L1; while the other group of patients
(1ESP) will receive ESP block at ipsilateral L1. L1 was chosen as an injection level, since
it is at the midpoint of corresponding spinal nerve roots innervating the groin (T12-L3). For
bi-level injection group, thoracic instead of another lower lumbar level was chosen to avoid
motor blockade caused by excessive local anaesthetic spread into lumbar plexus, leading to
delayed mobilisation which is undesirable for patients undergoing ambulatory surgery.
