Dexamethasone Versus Dexmedetomidine

NCT03064633 | Completed Phase 4

• 1 other identifier: M88
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dexamethasone; Dexmedetomidine; Transversus abdominis plane block; Local anesthetic adjuvants; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Time to first request of analgesia

  The time passed till the patient request an analgesic dose

  During the 24 hours postoperatively

Secondary Outcomes (36)

• Visual Analog Scale (VAS) at rest

  Assesment will be done at 2 hours postoperatively

• Visual Analog Scale (VAS) at rest

  Assesment will be done at 4 hours postoperatively

• Visual Analog Scale (VAS) at rest

  Assesment will be done at 6 hours postoperatively

• Visual Analog Scale (VAS) at rest

  Assesment will be done at 12 hours postoperatively

• Visual Analog Scale (VAS) at rest

  Assesment will be done at 18 hours postoperatively

Study Arms (2)

Dexamethasone arm (group A)

ACTIVE COMPARATOR

The local anesthetic solution mixture consists of dexamethasone 8 mg in Bupivacaine 0.25% Injectable Solution to a total volume of 40 ml (19 ml bupivacaine 0.5 % + 19 ml normal saline + 2 ml dexamethasone = 40ml). 20 ml of the local anesthetic solution mixture will be injected on each side.The Transversus abdominis Plane (TAP) block will be performed once after induction of anesthesia.

Drug: dexamethasone 8 mg; Drug: Bupivacaine 0.25% Injectable Solution

Dexmedetomidine arm (group B)

ACTIVE COMPARATOR

The local anesthetic solution mixture consists of dexmedetomidine 80 µg in Bupivacaine 0.25% Injectable Solution to a total volume of 40 ml (19 ml bupivacaine 0.5 % + 19 ml normal saline + 80 µg dexmedetomidine in 2 ml = 40ml). 20 ml of the local anesthetic solution mixture will be injected on each side.The Transversus abdominis Plane (TAP) block will be performed once after induction of anesthesia.

Drug: dexmedetomidine 80 µg; Drug: Bupivacaine 0.25% Injectable Solution

Interventions

dexamethasone 8 mg DRUG

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.

Also known as: Dexamethasone 4 mg/ml

Dexamethasone arm (group A)

dexmedetomidine 80 µg DRUG

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.

Also known as: precedex 100 µg/ml

Dexmedetomidine arm (group B)

Bupivacaine 0.25% Injectable Solution DRUG

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

Also known as: Marcaine 0.25%

Dexamethasone arm (group A); Dexmedetomidine arm (group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American society of anesthesiologists (ASA) physical status grade 1 and 2.
• Age of 18 years and more.
• Patients who will be scheduled for total abdominal hysterectomies.

You may not qualify if:

• Patient refusal.
• Body mass index (BMI) \> 40.
• Patients with chronic pain and those using chronic analgesic medications.
• Coagulopathy.
• Allergy to the study drugs.
• Patients taking other medications with α-adrenergic blocking effect.
• Hepatic or renal insufficiency.
• Systemic infection.
• Infection at the site of injection.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (4)

• Ammar AS, Mahmoud KM. Effect of adding dexamethasone to bupivacaine on transversus abdominis plane block for abdominal hysterectomy: A prospective randomized controlled trial. Saudi J Anaesth. 2012 Jul;6(3):229-33. doi: 10.4103/1658-354X.101213.

  PMID: 23162395 BACKGROUND

• Almarakbi WA, Kaki AM. Addition of dexmedetomidine to bupivacaine in transversus abdominis plane block potentiates post-operative pain relief among abdominal hysterectomy patients: A prospective randomized controlled trial. Saudi J Anaesth. 2014 Apr;8(2):161-6. doi: 10.4103/1658-354X.130683.

  PMID: 24843325 BACKGROUND

• Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.

  PMID: 23587874 BACKGROUND

• Gadsden J, Ayad S, Gonzales JJ, Mehta J, Boublik J, Hutchins J. Evolution of transversus abdominis plane infiltration techniques for postsurgical analgesia following abdominal surgeries. Local Reg Anesth. 2015 Dec 10;8:113-7. doi: 10.2147/LRA.S96253. eCollection 2015.

  PMID: 26677342 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hany M Yassin, MD

  Fayoum University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 27, 2017
• Study Start: March 8, 2017
• Primary Completion: April 28, 2018
• Study Completion: April 30, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)