NCT03051022

Brief Summary

The study aimed to compare the effectivity of dexamethasone 8 mg and morphine 2 mg as an adjuvant to epidural bupivacaine 0,125% 12,5mg for post-operative analgesia in lower extremities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

February 5, 2017

Last Update Submit

August 15, 2017

Conditions

Lower Extremities Fracture

Keywords

Bupivacaineadjuvantregional anesthesiadexamethasonemorphine

Outcome Measures

Primary Outcomes (3)

  • The degree of pain at 24-hours post-operative

    The degree of pain was measured using Visual Analog Scale (VAS)

    24 hours post-operative

  • The time for first requested post-operative additional analgesia

    How long (in minutes) until the subject requested for an additional analgesics after surgery.

    24 hours post-operative

  • The opioid requirement with the first 24-hours post-operative

    Patient Controlled Analgesia (PCA) measured the opioid requirement in milligram.

    24-hours post-operative

Secondary Outcomes (1)

  • Side Effects

    24-hours post-operative

Study Arms (2)

Dexamethasone 8 mg

ACTIVE COMPARATOR

Bupivacaine 0,125% 12,5 mg combined with dexamethasone 8 mg plus NaCl 0,9% until the volume was 10 cc, prepared in a 10 cc syringe.

Drug: Dexamethasone 8 mg

Morphine 2 mg

ACTIVE COMPARATOR

Bupivacaine 0,125% 12,5 mg combined with morphine 2 mg plus NaCl 0,9% until the volume was 10 cc, prepared in a 10 cc syringe.

Drug: Morphine 2 mg

Interventions

Dexamethasone 8 mgDRUG

Dexamethasone 8 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc.

Also known as: 0.9 % sodium chloride, 12.5 mg of 0.125% bupivacaine
Dexamethasone 8 mg
Morphine 2 mgDRUG

Morphine 2 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc.

Also known as: 0.9% sodium chloride, 12.5 mg of 0.125% bupivacaine
Morphine 2 mg

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects aged 18-60 years old with American Society of Anesthesiologists (ASA) physical status I-II and body mass index (BMI) 18,5-25 kg/m2 who were planned to undergo lower extremity surgery
  • Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form

You may not qualify if:

  • Subjects with history of bupivacaine allergy
  • Subjects with history of morphine allergy
  • Subjects with history of urine retention
  • Subjects with history of gait disturbance or using prosthetic, Subjects with history of peptic ulcer
  • Subjects with history of long term use of corticosteroid
  • Subjects with contraindications for epidural anesthesia
  • Subjects rejected to participate in the study.
  • Drop out criteria:
  • Subjects with epidural anesthesia complications (e.g. shock, anaphylactic reaction, seizures, severe respiratory disturbance)
  • Subjects with failed epidural anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Central Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (16)

  • Pakzad H, Roffey DM, Knight H, Dagenais S, Yelle JD, Wai EK. Delay in operative stabilization of spine fractures in multitrauma patients without neurologic injuries: effects on outcomes. Can J Surg. 2011 Aug;54(4):270-6. doi: 10.1503/cjs.008810.

    PMID: 21651838BACKGROUND

  • Nicola R. Early Total Care versus Damage Control: Current Concepts in the Orthopedic Care of Polytrauma Patients. ISRN Orthop. 2013 Mar 21;2013:329452. doi: 10.1155/2013/329452. eCollection 2013.

    PMID: 24959356BACKGROUND

  • Xing D, Chen Y, Ma JX, Song DH, Wang J, Yang Y, Feng R, Lu J, Ma XL. A methodological systematic review of early versus late stabilization of thoracolumbar spine fractures. Eur Spine J. 2013 Oct;22(10):2157-66. doi: 10.1007/s00586-012-2624-1. Epub 2012 Dec 22.

    PMID: 23263169BACKGROUND

  • Ramsay MA. Acute postoperative pain management. Proc (Bayl Univ Med Cent). 2000 Jul;13(3):244-7. doi: 10.1080/08998280.2000.11927683. No abstract available.

    PMID: 16389390BACKGROUND

  • Voscopoulos C, Lema M. When does acute pain become chronic? Br J Anaesth. 2010 Dec;105 Suppl 1:i69-85. doi: 10.1093/bja/aeq323.

    PMID: 21148657BACKGROUND

  • Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.

    PMID: 24436674BACKGROUND

  • Moraca RJ, Sheldon DG, Thirlby RC. The role of epidural anesthesia and analgesia in surgical practice. Ann Surg. 2003 Nov;238(5):663-73. doi: 10.1097/01.sla.0000094300.36689.ad.

    PMID: 14578727BACKGROUND

  • Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Prog. 2006 Fall;53(3):98-108; quiz 109-10. doi: 10.2344/0003-3006(2006)53[98:EOLAP]2.0.CO;2.

    PMID: 17175824BACKGROUND

  • Becker DE, Reed KL. Local anesthetics: review of pharmacological considerations. Anesth Prog. 2012 Summer;59(2):90-101; quiz 102-3. doi: 10.2344/0003-3006-59.2.90.

    PMID: 22822998BACKGROUND

  • Mercanoglu E, Alanoglu Z, Ekmekci P, Demiralp S, Alkis N. Comparison of intravenous morphine, epidural morphine with/ without bupivacaine or ropivacaine in post-thoracotomy pain management with patient controlled analgesia technique. Braz J Anesthesiol. 2013 Mar-Apr;63(2):213-9. doi: 10.1016/S0034-7094(13)70218-6.

    PMID: 23601264BACKGROUND

  • Nordquist D, Halaszynski TM. Perioperative multimodal anesthesia using regional techniques in the aging surgical patient. Pain Res Treat. 2014;2014:902174. doi: 10.1155/2014/902174. Epub 2014 Jan 20.

    PMID: 24579048BACKGROUND

  • Tomar GS, Godwin RB, Gaur N, Sethi A, Narang N, Kachhwaha V, Kriplani TC, Tiwari A. A double-blind study on analgesic effects of fentanyl combined with bupivacaine for extradural labor analgesia. Anesth Essays Res. 2011 Jul-Dec;5(2):147-52. doi: 10.4103/0259-1162.94754.

    PMID: 25885378BACKGROUND

  • George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.

    PMID: 23223119BACKGROUND

  • Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.

    PMID: 12818945BACKGROUND

  • Hefni AF, Mahmoud MS, Al Alim AA. Epidural dexamethasone for post-operative analgesia in patients undergoing abdominal hysterectomy: A dose ranging and safety evaluation study. Saudi J Anaesth. 2014 Jul;8(3):323-7. doi: 10.4103/1658-354X.136420.

    PMID: 25191180BACKGROUND

  • Thomas S, Beevi S. Epidural dexamethasone reduces postoperative pain and analgesic requirements. Can J Anaesth. 2006 Sep;53(9):899-905. doi: 10.1007/BF03022833.

    PMID: 16960268BACKGROUND

MeSH Terms

Interventions

DexamethasoneSodium ChlorideBupivacaineMorphine

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic Hydrocarbons

Study Officials

  • Aida R Tantri, PhD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Anesthesiologist

Study Record Dates

First Submitted

February 5, 2017

First Posted

February 13, 2017

Study Start

May 1, 2016

Primary Completion

November 30, 2016

Study Completion

March 31, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

ID(1)