Condition category
Musculoskeletal Diseases
Date applied
25/03/2018
Date assigned
16/05/2018
Last edited
17/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

San Rafael Hospital

Sponsor details

Carr. Panamericana 15
Santa Tecla
0000
El Salvador

Sponsor type

Hospital/treatment centre

Website

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

Editorial Notes

17/05/2018: Contact details for the principal investigator were added and the participant information sheet was uploaded.