E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain after cesarean section. |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this trial is to evaluate whether local peroperative administration of bupivacain with adrenaline (2,5 mg/ml and 5 microgram/ml) can decrease postoperative pain after cesarean section, decrease opiate consumption, decrease the time to mobilisation, the incidence of wound infections and long term scar pain.
Primary variables: Does bupivacaine influence the maximal postoperative pain during the first 24 hours? Does bupivacaine decrease the opiate consumption after 6, 12 and 24 hours (separately and accumulated)? Will administration of bupivacaine influence the time for mobilisation of the patient measured as the time period until the patients goes to the toilet for the first time, until the patient has her first defecation and until the medical treatment of the patient is considered finished?
|
|
E.2.2 | Secondary objectives of the trial |
Secondary variables: Will bupivacaine change the incidence of wound infections during the stay in the hospital? Will bupivacaine influence whether analgesia is still needed or not 10 days after the operation. Will bupivacaine influence the incidence of scar pain at 3, 6 and 12 months after the operation.
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients undergoing elective cesarean section at the Karolinska University Hospital, Huddinge. Age 18-50 years. Written consent to participate in the study. |
|
E.4 | Principal exclusion criteria |
Participation in another clinical trial within the last month before inclusion or during the study period. Other cause of pain with frequent use of potent analgetics. Other conditions that makes participation in the study difficult, like drug abuse, severe psychiatric disease or marked difficulties to communicate according to judgement of the investigator. Known intolerance or allergic reactions to opiates. Known intolerance or allergic reactions to NSAID. Known intolerance or allergic reactions to bupivacaine. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in maximal pain during the first 24 hours? Reduction in use of opiates during the first 6, 12 and 24 hours? Shortened time for mobilisation, measured as time from the operation to first visit to the toilet, first defecation and to the end of the medical treatment period?
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
At the time when the last questionnaire regarding long term scar pain has been sent in for the last patient included in the study. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |