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Completed

NCT Number: NCT03769818

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

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.

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Key information

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University

Aswān, 81528, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Bilateral TAP block with 20 ml of 0.25% bupivacaine

Other names: Active Comparator

Dexamethasone

Drug

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

Other names: active comparator

placebo to dexamethasone

Drug

Bilateral TAP block with placebo to dexamethasone.

placebo to bupivacaine

Drug

Bilateral TAP block with placebo to bupivacaine.

Primary outcomes

  1. Visual analog score for pain during movement

    Time frame: 24 hours post operative

    movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain

Secondary outcomes

  1. Visual analog score for pain during rest

    Time frame: 24 hours postoperative

    ranging from 0 to 10, where 0 no pain and 10 maximum pain

  2. number of patients need Fentanyl consumption

    Time frame: 24 hours postoperative

    calculation of the number of patients need Fentanyl consumption

  3. number of days patients stay in hospital

    Time frame: 4 weeks

    calculation of number of days patients stay in hospital

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2018
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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