Plain English Summary
Background and study aims
Pain management in El Salvador is underestimated; thousands of patients suffer intense pain after surgery, without any adequate protocol for painkillers (analgesics) based on intensity. Among Latin American countries, morphine sulfate is the painkiller with the lowest consumption rate for pain management, exposing the breach of patient’s right for pain relief.
This study aims to determine the effectiveness and safety of combining painkiller medication (multimodal analgesia) using preventative doses, combined with pain control after surgery.
Who can participate?
Adults aged 18 or over undergoing elective orthopedic surgery requiring spinal anesthesia
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive two painkillers (spinal morphine and bupivacaine) in combination prior to surgery. Those in the second group only receive one (bupivacaine). After surgery, all participants receive one drug (Ketorolac) to reduce swelling (anti-inflammatory). They are followed up for 24 hours, rating pain with a verbal scale and administered an appropriate drug for pain level based on guidance from the World Health Organisation.
What are the possible benefits and risks of participating?
Participants may potentially benefit from pain control in the first 24 hours after surgery, with individualized pain assessment and treatment. There is no monetary gain for participation in the study. Participants may be at risk of experiencing itchiness, difficulty urinating, nausea, vomiting and in very rare cases difficulty breathing.
Where is the study run from?
San Rafael Hospital (El Salvador)
When is the study starting and how long is it expected to run for?
June 2014 – November 2014
Who is funding the study?
Dr. Jose Matias Delgado University, affiliate of San Rafael Hospital (El Salvador)
Who is the main contact?
Dr Carlos Salazar (Scientific)
csalaz8@uic.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Carlos Salazar
ORCID ID
http://orcid.org/0000-0003-1758-3567
Contact details
San Rafael Hospital
Carr. Panamericana 15
Santa Tecla
60640
El Salvador
+503 2594 4000
csalaz8@uic.edu
Type
Scientific
Additional contact
Dr Carlos Salazar
ORCID ID
http://orcid.org/0000-0003-1758-3567
Contact details
Louis A. Weiss Memorial Hospital affiliate of the University of Illinois at Chicago
4646 North Marine Drive
Chicago
Illinois
Chicago
60640
United States of America
+1 773 878 8700
csalaz8@uic.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PH7
Study information
Scientific title
Multimodal analgesia using 100 μg of preemptive intrathecal morphine sulfate combined with hyperbaric bupivacaine for postoperative pain control in orthopedic surgery: a double blind randomized clinical trial
Acronym
Study hypothesis
Multimodal analgesia using a single dose of preemptive intrathecal morphine sulfate added to hyperbaric bupivacaine for spinal anesthesia is more effective compared to postoperative opioid and non-opioid pain control after orthopedic surgery
Ethics approval
San Rafael Hospital Investigation Ethics Committee, 26/06/2013, ref: 4570
Study design
Phase IV single center double blind randomized clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional file
Condition
Pain control
Intervention
Participants are randomly allocated to the experimental group or control. Those in the experimental group (M1) receive 100 μg of intrathecal morphine sulfate combined with 1-2 mL of hyperbaric bupivacaine for spinal anesthesia on the preoperative setting. The control group (M0) receive 1-2 mL of hyperbaric bupivacaine alone.
Both groups (M1) and (M0) receive 30 mg of Ketorolac I.V. for anti-inflammatory effect on the time of discharge from the recovery room, and they are followed up to 24 hours in the orthopedic department, evaluating episodes of pain intensity with Verbal Numerical Rating Scale (VNRS) and administrating for every single pain episode a dose of Paracetamol 500-1000 mg PO, Tramadol 50 mg PO, Ketorolac 30 mg I.V. or 60 mg I.M., Diclofenac 75 mg I.M. or Meperidine 50 mg I.V. based on WHO's analgesic ladder.
Intervention type
Drug
Phase
Phase IV
Drug names
Primary outcome measure
Pain is assessed by the following:
1.1. Individual interviews before discharge from the Post-Anesthesia Care Unit (baseline) and every single episode of pain during the first 24 hour post-operative period
1.2. Time to appearance of first episode of pain in the 24 hour post-operative period
1.3. Intensity of pain was measured using the verbal numeric rating scale (VNRS)
1.4. Frequency of pain episodes is measured throughout the 24 hour post-operative period
Secondary outcome measures
1. Type and quantity of analgesics needed is measured according the WHO's analgesic ladder throughout the 24 hour post operative period
2. Frequency of episodes of pruritus, nausea and vomiting, respiratory depression, and urinary retention are measured throughout the 24 hour post operative period
3. Patient satisfaction is evaluated using using a questionnaire based on the Likert scale in the first 24 hours
Overall trial start date
15/01/2013
Overall trial end date
28/11/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 18 years and older
2. ASA I and II
3. Lower limb fracture
4. Elective orthopedic surgery
5. Spinal anesthesia
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80 patients
Participant exclusion criteria
1. <18 years-old
2. ASA > II
3. Documented allergy to opioids or non opioid analgesics
4. Emergency surgery
5. BMI >35
6. Asthma
7. Obstructive sleep apnea
8. Chronic use of opioids defined as more than > 2 weeks
9. Pregnancy
10. History of drug abuse or alcohol use
11. History of psychiatric condition
Recruitment start date
01/04/2014
Recruitment end date
15/10/2014
Locations
Countries of recruitment
El Salvador
Trial participating centre
San Rafael Hospital
Santa Tecla
0000
El Salvador
Funders
Funder type
University/education
Funder name
Dr. Jose Matias Delgado University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Carlos Salazar, csalaz8@uic.edu
Additional documentation:
Protocol available at: http://www.redicces.org.sv/jspui/handle/10972/1879
Intention to publish date
10/05/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN10993984_PIS_v1_14May18.pdf Uploaded 17/05/2018