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

• ClinicalTrials.gov Identifier: NCT03769818
• Recruitment Status: Completed
• First Posted: December 10, 2018
• Last Update Posted: August 5, 2020
• Sponsor: Aswan University Hospital
• Information provided by (Responsible Party): hany farouk, Aswan University Hospital

Tracking Information

• First Submitted Date: December 6, 2018
• First Posted Date: December 10, 2018
• Last Update Posted Date: August 5, 2020
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: March 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 6, 2018)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 6, 2018)

• 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
• number of patients need Fentanyl consumption [ Time Frame: 24 hours postoperative ]
  calculation of the number of patients need Fentanyl consumption
• number of days patients stay in hospital [ Time Frame: 4 weeks ]
  calculation of number of days patients stay in hospital

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A prospective Randomized Interventional double-blind study.

Masking: Quadruple (Participant, Care Provider, 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.

Primary Purpose: Prevention

• Condition: Postoperative Pain

Intervention

• Drug: bupivacaine
  Bilateral TAP block with 20 ml of 0.25% bupivacaine
  Other Name: Active Comparator
• Drug: dexamethasone
  Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.
  Other Name: active comparator
• Drug: placebo to dexamethasone
  Bilateral TAP block with placebo to dexamethasone.
• Drug: placebo to bupivacaine
  Bilateral TAP block with placebo to bupivacaine.

Study Arms

• Active Comparator: bupivacaine and dexamethasone
  Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
  Interventions:

  • Drug: bupivacaine
  • Drug: dexamethasone
• Active Comparator: bupivacaine and placebo to dexamethasone
  Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
  Interventions:

  • Drug: bupivacaine
  • Drug: placebo to dexamethasone
• Placebo Comparator: control group
  Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 6, 2018): 150
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 1, 2020
• Actual Primary Completion Date: March 30, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: patients undergoing total abdominal hysterectomy

• Ages: 30 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03769818
• Other Study ID Numbers: aswu/181/18
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: hany farouk, Aswan University Hospital
• Study Sponsor: Aswan University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: hany f sallam, md; Aswan University Hospital

• PRS Account: Aswan University Hospital
• Verification Date: August 2020