Dexamethasone Versus Dexmedetomidine

NCT03064633 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-06-06

No results posted yet for this study

Summary

The transversus abdominis plane (TAP) block is most often used to provide surgical anesthesia for minor, superficial procedures on the lower abdominal wall, or postoperative analgesia for procedures below the umbilicus providing anesthesia to the ipsilateral lower abdomen below the umbilicus.

In a recent meta-analysis, the TAP block was shown to reduce the need for postoperative opioid use, increase the time to the first request for further analgesia, and provide more effective pain relief, while decreasing opioid-related side effects such as sedation and postoperative nausea and vomiting. The provision of effective postoperative analgesia is of key importance to facilitate early ambulation and prevention of postoperative morbidity. The analgesic regimen needs to meet the goals of providing safe, effective analgesia, with minimal side effects. Many additives to local anesthetics used to prolong the duration of analgesia for peripheral nerve blocks have been studied as dexamethasone, dexmedetomidine Dexmedetomidine is a lipophilic α2 agonist derivative with a higher affinity for α2-receptors than clonidine (α2: α1 specificity ratio is 200:1 for clonidine and 1600:1 for dexmedetomidine). It has sedative, analgesic, and sympatholytic effects that blunt many of the cardiovascular responses seen during the perioperative period. Animal and human studies have shown safety and efficacy of adding dexmedetomidine to local anesthetics in various regional anesthetic procedures. The addition of dexmedetomidine to bupivacaine in TAP block achieves better local anesthesia and provides better pain control postoperatively without any major side-effects.

Dexamethasone is a systemic glucocorticoid that improves the quality of recovery after surgery by reducing pain, nausea, and vomiting. When added to local anesthetics as an adjuvant in peripheral blocks, it prolongs the analgesia time. Mechanism of action may be through the anti-inflammatory action, the increase of the local efficiency, and to slow down of the absorption.

Objective:

The objective is to compare and evaluate efficacy and safety of dexmedetomidine and dexamethasone as a local anesthetic adjuvant to bupivacaine in ultrasound-guided TAP block for patients scheduled for total abdominal hysterectomies.

Conditions

  • Postoperative Pain

Interventions

DRUG

dexamethasone 8 mg

At the level of the umbilicus, the high-frequency ultrasound linear array probe (L 4 - 12) will be placed transversely on the anterolateral abdominal wall between the subcostal margin and the iliac crest. localization of the fascial plane between the internal oblique and the transversus abdominis muscles will be done. The local anesthetic solution mixture will be injected with short bevel needle. The TAP block will be performed on the both side using the same technique and the same local anesthetic solution mixture volume. For the patients randomized to dexamethasone group, the local anesthetic solution mixture will consist of a total volume of 40 ml containing bupivacaine 0.25 % and dexamethasone 8 mg.

DRUG

dexmedetomidine 80 µg

At the level of the umbilicus, the high-frequency ultrasound linear array probe (L 4 - 12) will be placed transversely on the anterolateral abdominal wall between the subcostal margin and the iliac crest. localization of the fascial plane between the internal oblique and the transversus abdominis muscles will be done. The local anesthetic solution mixture will be injected with short bevel needle. The TAP block will be performed on the both sides using the same technique and the same local anesthetic solution mixture volume. For the patients randomized to dexmedetomidine group, the local anesthetic solution mixture will consist of a total volume of 40 ml containing bupivacaine 0.25 % and dexmedetomidine 80 µg.

DRUG

Bupivacaine 0.25% Injectable Solution

38 ml of the solution will be prepared to be used in transversus abdominis plane block

Sponsors & Collaborators

  • Fayoum University Hospital

    lead OTHER

Principal Investigators

  • Hany M Yassin, MD · Fayoum University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2018-04-28
Completion
2018-04-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03064633 on ClinicalTrials.gov