Clinical trial NCT03769818: Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy
Official title: Role of Adjuvant Dexamethasone for Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: erector spinae plane block
total abdominal hysterectomy
dexamethasone
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective Randomized Interventional double-blind study.
Primary purpose: PREVENTION

Brief summary: The aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone for erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy Group 1: bupivacaine 0.25% + dexamethasone 8 mg

* Group 2: bupivacaine 0.25%
* Group3: control group A prospective Randomized Interventional double-blind study.

Detailed description: Optimal dynamic analgesia is recognized as the key to enhanced recovery following open abdominal surgery. In the last decade, there has been a significant shift away from thoracic epidural analgesia (TEA) that has been long considered as the gold standard. Various techniques have tried to replicate the analgesic efficacy of TEA. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and trans muscular quadratus lumborum analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries. Chin et al first described the erector spinae plane (ESP) block for providing analgesia following ventral hernia repair. The unique feature of the ultrasound-guided truncal blocks is that in all of these techniques, in contrast to peripheral nerve blocks, no nerve or plexus needs to be identified: Local anesthesia (LA) is injected in a particular muscle plane, in which the injectate spreads and reaches the intended nerves. This simple mechanism has made delivery of nerve blocks easy and versatile.

Eligibility criteria: Inclusion Criteria:

* Women ranging age between 30-60 years a who undergoing elective total abdominal hysterectomy

Exclusion Criteria:

* Participants had known sensitivity to bupivacaine
* Participants had difficulty in intubation
* Participants were on chronic pain medication or already on long-term opioids
* Participants smokers
* Participants with disabilities who were unable to communicate pain levels
* refuse to consent

Primary outcomes:
measure: Visual analog score for pain during movement
timeFrame: 24 hours post operative
Secondary outcomes:
measure: Visual analog score for pain during rest
timeFrame: 24 hours postoperative
measure: number of patients need Fentanyl consumption
timeFrame: 24 hours postoperative
measure: number of days patients stay in hospital
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References: