Pain control with spinal morphine combined with spinal anesthesia before orthopedic surgery
| ISRCTN | ISRCTN10993984 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10993984 |
| Secondary identifying numbers | PH7 |
- Submission date
- 25/03/2018
- Registration date
- 16/05/2018
- Last edited
- 24/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
San Rafael Hospital
Carr. Panamericana 15
Santa Tecla
60640
El Salvador
 ORCID ID |
0000-0003-1758-3567 |
|---|---|
| Phone | +503 2594 4000 |
| csalaz8@uic.edu |
Scientific
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
| ORCID ID |
0000-0003-1758-3567 |
|---|---|
| Phone | +1 773 878 8700 |
| csalaz8@uic.edu |
Study information
| Study design | Phase IV single center double blind randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN10993984_PIS_v1_14May18.pdf |
| 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 |
| Study objectives | 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(s) | San Rafael Hospital Investigation Ethics Committee, 26/06/2013, ref: 4570 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 15/01/2013 |
| Completion date | 28/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 patients |
| Key inclusion criteria | 1. 18 years and older 2. ASA I and II 3. Lower limb fracture 4. Elective orthopedic surgery 5. Spinal anesthesia |
| Key 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 |
| Date of first enrolment | 01/04/2014 |
| Date of final enrolment | 15/10/2014 |
Locations
Countries of recruitment
- El Salvador
Study participating centre
0000
El Salvador
Sponsor information
Hospital/treatment centre
Carr. Panamericana 15
Santa Tecla
0000
El Salvador
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 10/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal. |
| IPD sharing plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1 | 14/05/2018 | 17/05/2018 | No | Yes |
Additional files
- ISRCTN10993984_PIS_v1_14May18.pdf
- Uploaded 17/05/2018
Editorial Notes
24/04/2019: Internal review.
17/05/2018: Contact details for the principal investigator were added and the participant information sheet was uploaded.
