Post-operative Analgesia in Women Undergoing Open Abdominal Gynaecologic Oncology Surgery with or without Ultrasound Guided Bilateral Erector Spinae Plane Block: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total epidural fentanyl consumption
Study Overview
Brief Summary
Adequate postoperative analgesia can reduce morbidity and mortality associated with open
abdominal gynaecologic oncology surgery by allowing early ambulation, decreasing hospital
stay, thromboembolism, and other adverse outcome. Routinely opioids are used for managing
post-operative pain relief after major surgery with associated side effects like respiratory
depression, nausea, vomiting, constipation and drowsiness. Opioids delivered through epidural
route offer advantage of superior pain relief with reduction in the consumption. However,
epidural analgesia is associated with adverse effects like hypotension, delayed ambulation, ileus
and failed block.
USG guided bilateral erector spinae plane block is a comparatively new analgesic modality in
thoracic and abdominal surgery which is easy to administer and proposed to have comparable
analgesia and decreased complications compared to that with epidural analgesia.
This is a randomized controlled study to be conducted among 60 adult females undergoing
elective open abdominal gynaecologic oncology surgery under general anaesthesia with patient
controlled epidural analgesia (PCEA). Patients will be randomly allocated to two groups (Group
A, Group B) of 30 each. Group A will receive ultrasound (USG) guided bilateral erector spinae
plane block. Group B will not receive erector spinae plane block. Post-operative consumption of
fentanyl via PCEA pump and rescue analgesia with systemic opioids received will be assessed
for 24 hours. Post-operative analgesia in terms of visual analogue scale (VAS), haemodynamic
changes, sedation, nausea and vomiting will be compared between both the groups. We
hypothesise that USG guided bilateral erector spinae plane block could provide adequate post-
operative analgesia thereby reducing post-operative fentanyl consumption in women undergoing
open abdominal gynaecologic oncologic surgery with lesser side effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •ASA I-III
- •Patients undergoing elective open abdominal gynaecologic oncology surgery.
Exclusion Criteria
- •1.Emergency surgery 2.Anomalies of vertebral column 3.Any lesion obscuring sonoanatomy 4.Blood or CSF tap during the procedure 5.Failed blocks 6.Patient on anticoagulants or bleeding diathesis 7.Previous history of local anaesthetic allergy 8.History of obstructive sleep apnoea 9.Patients not consenting to participate in the study.
Outcomes
Primary Outcomes
Total epidural fentanyl consumption
Time Frame: After 24 hour
Secondary Outcomes
- Post-operative vitals including heart rate, blood pressure, Post-operative pain using 10cm Visual Analogue Scale (VAS) score, PONV and sedation.(30min,2hr,4hr,6hr,12hr,24hrs)
Investigators
Anjali Gera
Sir Gangaram Hospital, New Delhi