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Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement.
Condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam Phase: Not applicable
study type: randomized clinical trial actual enrollment: 119 allocation: Random intervention model: three groups assignment masking: open lebal primary purpose: pain relief after Cesarean section actual study start: March 3, 2019 Primary Completion: March 5, 2020 actual study completion date: May 9, 2020
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bupivacaine group | Active Comparator | included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline. |
|
| meloxicam group | Active Comparator | included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline. |
|
| placebo group | Active Comparator | included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local ifiltration Bupivacaine, Meloxican and placebo | Drug | no other intervention done |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain scores | Assessment of pain scores after Cesarean section | immediately after the intervention |
| Postoperative analgesic requirements | Assessment of Postoperative analgesic requirements | immediately after the intervention |
| time of first dose of analgesia | Determination of time of first dose of analgesia | immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative fever | Assessment of Postoperative fever | immediately after the intervention |
| onset of mobilization | Assessment of onset of mobilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed E Anter, MD | Menoufia University hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia University hospital | Shibīn al Kawm | Menoufia | 11111 | Egypt |
through the E-maill address
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Group A (bupivacaine group): included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline.
Group B (meloxicam group): included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline.
Group C (placebo group): included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.
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Each woman received a disposable syringe containing a medication corresponding to her order of participation in the trial. Packing. Sealing and numbering were performed by health care provider who did not actively share in the process of the study.
| immediately after the intervention |
| side effects of medications | Assessment of side effects of medications | immediately after the intervention |
| Pain assessment by visual analogue scale | Post-operative pain assessment was done using a 10-point visual analogue scale | immediately after the intervention |