Trial · NCT01571791
Perioperative Ketorolac-lidocaine in the Patients With Valvular Heart Diseases During Cesarean Delivery
NCT01571791, Phase 2, Suspended, Mansoura University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Perioperative Ketorolac-lidocaine in the Patients With Valvular Heart Diseases During Cesarean Delivery. Trials, record NCT01571791. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01571791
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perioperative Ketorolac-lidocaine in the Patients With Valvular Heart Diseases During Cesarean Delivery
- NCT number
- NCT01571791
- Status
- Suspended
- Phases
- Phase 2
- Enrollment
- 90 participants, estimated
- Lead sponsor
- Mansoura University
- Conditions
- Valve Heart Disease, Elective Cesarean Delivery
- Interventions
- Placebo, Ketorolac-Lidocaine
- First posted
- 2012-04-05
- Last updated
- 2020-09-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | hemodynamics | Baseline, intraoperative, an expected average of 1 hour | changes in blood pressures and heart rate |
| Secondary | changes in fentanyl consumption | intraoperative, an expected average of 1 hour | Intraoperative fentanyl consumption |
| Secondary | perioperative bleeding | intraoperative, an expected average of 1 hour, up to 24 hours after surgery | Intra-operative blood loss will be assessed by measuring blood in the suction bottle minus the sonographically estimated amniotic fluid volume, visual estimate of blood on drapes and floor and weighing swabs after use. Postoperative transfusion requirements and blood loss will be estimated as previously reported by Huang et al. from inspection of the perineal pad (0: small; 1: moderate; 2: large). Haematocrit values will be recorded before and 48 h after surgery. |
| Secondary | neonatal outcome | up to 24 hours after delivery | Neonatal umbilical artery and umbilical vein blood pH, gas tensions, and base excess values. Apgar scores at 1 and 5 min, and newborns' blood pressure, heart rate, temperature, arterial oxygen saturation, and the Neurologic and Adaptive Capacity Score (NACS) will be recorded at 15 min, 2 and 24 h after delivery. |
| Secondary | uterine tone | intraoperative, an expected average of 1 hour | The obstetrician will assess uterine tone by palpation every 5 minutes after delivery of the placenta using a 10-cm VAS (0: well contracted; 10: completely relaxed). If uterine tone remains unsatisfactory after 3 min, an additional 5 U bolus of oxytocin will be administered. |
| Secondary | postoperative pain | up to 24 after surgery | a 10-cm VAS at rest and on movement (0: no pain; 10: worst pain imaginable) 0, 1, 2, 4, 6, 8, 10 and 12 h after surgery. For postoperative pain relief intravenous 100 mg will be given when VAS scores are 5 or more at rest, or 7 or more on movement, or if the patient requests additional analgesia. The time to first request for analgesia and the number of subjects receiving tramadol during the first 12 h will be recorded. |
| Secondary | perioperative side effects | up to 24 after surgery | perioperative side effects includes arrhythmia, sedation, nausea and vomiting, light-headedness, headache, perioral numbness, tunnel vision, or seizures |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01571791
GET https://conductscience.org/api/trials/v1/NCT01571791/registered