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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: bupivacaine; Drug: dexamethasone; Drug: placebo to dexamethasone; Drug: placebo to bupivacaine

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
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bupivacaine and dexamethasone; Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.	Drug: bupivacaine; Bilateral TAP block with 20 ml of 0.25% bupivacaine; Other Names: Active Comparator; Drug: dexamethasone; Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.; Other Names: active comparator
Active Comparator: bupivacaine and placebo to dexamethasone; Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone	Drug: bupivacaine; Bilateral TAP block with 20 ml of 0.25% bupivacaine; Other Names: Active Comparator; Drug: placebo to dexamethasone; Bilateral TAP block with placebo to dexamethasone.
Placebo Comparator: control group; Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone	Drug: placebo to dexamethasone; Bilateral TAP block with placebo to dexamethasone.; Drug: placebo to bupivacaine; Bilateral TAP block with placebo to bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog score for pain during movement	movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain	24 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of days patients stay in hospital	calculation of number of days patients stay in hospital	4 weeks
Visual analog score for pain during rest	ranging from 0 to 10, where 0 no pain and 10 maximum pain	24 hours postoperative
number of patients need Fentanyl consumption	calculation of the number of patients need Fentanyl consumption	24 hours postoperative

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: dexamethasone; erector spinae plane block; total abdominal hysterectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Bupivacaine
• Other Study ID Numbers: aswu/181/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No