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Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy

Role of Adjuvant Dexamethasone for Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Double-blind Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03769818
Enrollment
150
Registered
2018-12-10
Start date
2019-01-01
Completion date
2020-08-01
Last updated
2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

erector spinae plane block, total abdominal hysterectomy, dexamethasone

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.

Interventions

DRUGbupivacaine

Bilateral TAP block with 20 ml of 0.25% bupivacaine

DRUGdexamethasone

Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.

Bilateral TAP block with placebo to dexamethasone.

DRUGplacebo to bupivacaine

Bilateral TAP block with placebo to bupivacaine.

Sponsors

Aswan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete for group 1 and 2.

Intervention model description

A prospective Randomized Interventional double-blind study.

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analog score for pain during movement24 hours post operativemovement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain

Secondary

MeasureTime frameDescription
number of days patients stay in hospital4 weekscalculation of number of days patients stay in hospital
Visual analog score for pain during rest24 hours postoperativeranging from 0 to 10, where 0 no pain and 10 maximum pain
number of patients need Fentanyl consumption24 hours postoperativecalculation of the number of patients need Fentanyl consumption

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026