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

A

Aswan University Hospital

Status

Completed

Conditions

Postoperative Pain

Treatments

Drug: dexamethasone
Drug: placebo to dexamethasone
Drug: placebo to bupivacaine
Drug: bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03769818
aswu/181/18

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Female

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 3 patient groups, including a placebo group

bupivacaine and dexamethasone
Active Comparator group
Description:
Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
Treatment:
Drug: bupivacaine
Drug: dexamethasone
bupivacaine and placebo to dexamethasone
Active Comparator group
Description:
Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
Treatment:
Drug: placebo to dexamethasone
Drug: bupivacaine
control group
Placebo Comparator group
Description:
Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone
Treatment:
Drug: placebo to dexamethasone
Drug: placebo to bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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