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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-08-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective Randomized Interventional double-blind study.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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bupivacaine and dexamethasone

Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.

Group Type ACTIVE_COMPARATOR

bupivacaine

Intervention Type DRUG

Bilateral TAP block with 20 ml of 0.25% bupivacaine

dexamethasone

Intervention Type DRUG

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

bupivacaine and placebo to dexamethasone

Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone

Group Type ACTIVE_COMPARATOR

bupivacaine

Intervention Type DRUG

Bilateral TAP block with 20 ml of 0.25% bupivacaine

placebo to dexamethasone

Intervention Type DRUG

Bilateral TAP block with placebo to dexamethasone.

control group

Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone

Group Type PLACEBO_COMPARATOR

placebo to dexamethasone

Intervention Type DRUG

Bilateral TAP block with placebo to dexamethasone.

placebo to bupivacaine

Intervention Type DRUG

Bilateral TAP block with placebo to bupivacaine.

Interventions

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bupivacaine

Bilateral TAP block with 20 ml of 0.25% bupivacaine

Intervention Type DRUG

dexamethasone

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

Intervention Type DRUG

placebo to dexamethasone

Bilateral TAP block with placebo to dexamethasone.

Intervention Type DRUG

placebo to bupivacaine

Bilateral TAP block with placebo to bupivacaine.

Intervention Type DRUG

Other Intervention Names

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Active Comparator active comparator

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No