Cesarean Section Pain
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGlocal ifiltration Bupivacaine, Meloxican and placebo
no other intervention done
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 21-40 years * Elective C.S at term * Patient having no medical disorders * Patient with no obstetrical complications
Exclusion criteria
* extreme of reproductive age * allergy to local anesthetic infiltration agent * any medical disorders or obstetrical complications as ante partum hemorrhag, pre-eclampsia * refusal to participate in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores | immediately after the intervention | Assessment of pain scores after Cesarean section |
| Postoperative analgesic requirements | immediately after the intervention | Assessment of Postoperative analgesic requirements |
| time of first dose of analgesia | immediately after the intervention | Determination of time of first dose of analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative fever | immediately after the intervention | Assessment of Postoperative fever |
| Pain assessment by visual analogue scale | immediately after the intervention | Post-operative pain assessment was done using a 10-point visual analogue scale |
| onset of mobilization | immediately after the intervention | Assessment of onset of mobilization |
| side effects of medications | immediately after the intervention | Assessment of side effects of medications |
Countries
Egypt
Outcome results
None listed