Ropivacaine for pain management in patients who undergo Caesarean section
| ISRCTN | ISRCTN15849443 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15849443 |
- Submission date
- 01/05/2022
- Registration date
- 24/05/2022
- Last edited
- 24/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
A Caesarean section is surgery to deliver a baby. The baby is taken out through the mother's abdomen. Some Caesarean sections are planned, but many are done when unexpected problems happen during delivery.
Pain following a Caesarean section has a negative influence on the child and mother. The main aim of this study is to analyse the postoperative pain after a dosage of preperitoneal ropivacaine.
Who can participate?
Women between the age of 18 and 40 years with full-term pregnancy, undergoing a planned or elective Caesarean section.
What does the study involve?
Patients were randomly allocated to two groups: group A would receive general analgesics (ketorolac) and ropivicaine while group B would only receive general analgesics. Pain is measured using the visual analogue scale (VAS).
What are the possible benefits and risks of participating?
The benefits of this trial include reduction of postoperative pain, a reduction of complications due to pain, reduction of hospital stay and a reduction in hospitalization costs. The possible risks include those caused by the ropivacaine drug-like hematomas, nausea, vomiting and ecchymosis; those due to the intravenous infiltration of ropivacaine like tinnitus, metallic taste, paresthesia, vertigo, anxiety, nystagmus, hallucinations, convulsions, apnea and coma, all of which were prevented, treated and registered.
Where is the study run from?
The Division of Obstetrics, High Specialty Medical Unit of the Hospital of Gynecology and Pediatrics # 48, part of the Mexican Social Security Institute (Mexico)
When is the study starting and how long is it expected to run for?
August 2018 to February 2020
Who's funding the study?
Investigator initiated and funded
Who's the main contact?
Gloria Patricia Sosa Bustamante, patriciasosab@hotmail.com
Contact information
Public
Av. Paseo de los Insurgentes S/N.
Col. Los Paraísos
Guanajuato
León
37328
Mexico
 ORCID ID |
0000-0002-8460-4965 |
|---|---|
| Phone | +52 477 7174800 Ext: 31804 |
| patriciasosab@hotmail.com |
Scientific
Av. Paseo de los Insurgentes S/N.
Col. Los Paraísos
Guanajuato
León
37328
Mexico
| Phone | +52 477 7174800 Ext: 31804 |
|---|---|
| gloria.sosa@imss.gob.mx |
Principal Investigator
Av. Paseo de los Insurgentes S/N.
Col. Los Paraísos
Guanajuato
León
37328
Mexico
| Phone | +52 477 7174800 Ext: 31804 |
|---|---|
| gloria.sosa@imss.gob.mx |
Study information
| Study design | Randomized double-blind controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 41682 PIS.pdf |
| Scientific title | Preperitoneal ropivacaine in the management of postoperative pain in post-Caesarean section patients |
| Study objectives | Preperitoneal ropivacaine in the postoperative management is effective against the pain in post-cesarean section patients, |
| Ethics approval(s) | Approved 29/08/2018, Ethics Committee for Health Research (Comité de Ética para la Investigación en Salud, Avenue Paseo de los Insurgentes, col. Los Paraísos, 37328 Leon Gto, Mexico; +52 477 717 4800 ext.31800; comision.etica@imss.gob.mx), ref: 10028 |
| Health condition(s) or problem(s) studied | Post-operative pain management in patients who undergo cesarean section |
| Intervention | The patients were randomly assigned, by simple random sampling, into two groups (A and B), in accordance with a table of random numbers. Preperitoneal ropivacaine was administered in group A, while group B (control) did not receive this. In the operating room, they were administered regional anesthesia through L2 - L3 epidural block, with 2% lidocaine with epinephrine, at a dose of 4 mg per kg of body weight, with a latency time of 10 to 15 minutes. The cesarean section was performed with the conventional technique, with a mid-infraumbilical incision in the skin and a Kerr-type incision in the uterus, the hysterorrhaphy was sutured in three planes. Before proceeding with the closure of the surgical wound, patients in group A received preperitoneal ropivacaine. The perincisional parietal peritoneum (subfascial) was located and taken with four Kelly forceps, a 22 G needle was inserted, up to 2 cm deep over the edge of the peritoneum, in the preperitoneal space and at an angle of 45 °, 30 ml were infiltrated of ropivacaine 0.75%, corresponding to 225 mg total (7.5 mg/ml bottle). In group B patients, the conventional cesarean section was performed in the same way as previously explained, but without the application of ropivacaine. No substance was administered as a placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ropivacaine |
| Primary outcome measure | Pain was measured using the VAS scale at the end of the surgery (baseline), 2, 6, 12, 18 and 24 hours after surgery. |
| Secondary outcome measures | 1.Use of rescue doses was measured using the VAS scale at the end of the surgery (baseline), 2, 6, 12, 18 and 24 hours after surgery. 2. Days of hospital stay were measured using the medical record over a 10 day period after the surgery 3. Presence of adverse events was measured using medical examination over a 10 day period after the surgery |
| Overall study start date | 29/08/2018 |
| Completion date | 22/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 2 clusters with 41 participants each |
| Total final enrolment | 81 |
| Key inclusion criteria | 1. Women from 18 to 40 years of age 2. Term pregnancy 3. Undergoing programmed or elective cesarean section |
| Key exclusion criteria | 1. Chronic diseases 2. Placental disorders 3. Infections 4. Aallergies to anesthetics 5. Contraindication to regional anesthesia 6. Obstetric emergency 7. History of drug abuse 8. Inability to understand the visual analog scale |
| Date of first enrolment | 17/10/2018 |
| Date of final enrolment | 20/12/2019 |
Locations
Countries of recruitment
- Mexico
Study participating centre
León
37328
Mexico
Sponsor information
Government
Av. Paseo de los Insurgentes S/N.
Col. Los Paraísos
León
Guanajuato
Mexico City
37328
Mexico
| Phone | +52 477 1329126 |
|---|---|
| alma.gonzalezx@imss.gob.mx | |
| Website | http://www.imss.gob.mx/ |
"ROR" |
https://ror.org/03xddgg98 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 20/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, 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 Gloria Patricia Sosa Bustamante with the emails patriciasosab@hotmail.com and gloria.sosa@imss.gob.mx. The type of data that will be shared only includes clinical variables (acronyms for the names, age, BMI, births, past cesarean sections and gestational age). The individual participant dara will be available upon request and for an undetermined amount of time. The data will not be shared with anyone unless the platform ISRCTN requests the data through the emails that were shared earlier to corroborate the existence of the IPD. Anonymisation will be kept by using acronyms of the participants' names. As of the ethical restrictions, on the informed consent, the researchers indicated to the participants that their personal data would be protected as well as that clinical variables would only be used for the analysis of the data and publication on a scientific journal. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other unpublished results | 19/05/2022 | No | No | ||
| Participant information sheet | 19/05/2022 | No | Yes |
Additional files
Editorial Notes
19/05/2022: Trial's existence confirmed by Comité de Ética para la Investigación en Salud.
