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The efficiency of etofenamate spray on pain of postoperative cesarean section

The evaluation of the efficiency of etofenamate spray in postoperative cesarean pain: Randomized, double-blind, placebo-controlled study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR201811864509898
Enrollment
200
Registered
2018-11-29
Start date
2018-11-28
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the pain of postoperative cesarean section

Interventions

Experimental group
Control group

Sponsors

MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women between the ages of 18-40 2. Having pregnancy between 37-42 weeks 3. Women who were delivered by cesarean 4. Pregnant women with BMI <35 5. Additional operations will be performed outside cesarean section pregnant women 6. Pregnant women volunteering to enter the study. 7. Primer cesarean sections

Exclusion criteria

Exclusion criteria: 1. Pregnant women who do not want to participate in the study 2. Pregnant women with severe adhesion in operation 3. Pregnant women with BMI> 35 4. Pregnant women who underwent other operations during cesarean 5. Pregnant women who have previous cesarean sections

Design outcomes

Primary

MeasureTime frame
If the efficacy of the locally used etofenamate spray can be confirmed by our study, the amount of systemic analgesic used can be reduced. Cesarean operation is increasing in all over the world and in our country. Paracetamol, diclofenac sodium and opioids are usually used in the fight against post-cesarean pain. Of these drugs, paracetamol is safe after cesarean but has low efficacy and can be side effects to liver in its frequent use. Diclofenac sodium is also an effective drug, but it requires repeated doses and can pass into milk and cause side effects to the kidneys. Opioids have high efficacy, but they can undergo both mother and milk and cause respiratory depression. These drugs used are all systemically administered. We aimed to provide both analgesic effect and reduce the dose of other systemic drugs by using the etofenamate (doline 50 ml) spray locally around the incision. A total of 200 patients who come to our hospital from all parts of Somalia are randomly ordered (single and double) in order to come up with the number 1 spray (ethofenamate spray) to the number 1, 2 to 2 number 2 to the number 2 times to the incision. It will be tightened. The study is planned as double-blind and placebo-controlled. Serum physiologic will be put into spray No. 2. Practitioner assistant and patient box contents will not know. The application will be performed 4 times in total 24 hours postoperatively. All patients will receive paracetamol IV as standard analgesic doses. If analgesic is insufficient, tramadol 50 mg doses will be added and recorded. Visually numerical pain scale (VNS) will perform to both groups at 0-6-12-24. hours. Demographic data, duration of operation, type of anesthesia, need for additional operation, incision size, additional analgesic need, VNS data will be recorded. When sufficient number of patients are reached, all data are transferred to SPSS environment and statistical analysis is done and then writing is started.

Secondary

MeasureTime frame
If the effect of local etofenamate spray is shown, the use of less systemic analgesics will result in less complications and less cost. If the efficacy of the locally used etofenamate spray can be confirmed by our study, the amount of systemic analgesic used can be reduced. Cesarean operation is increasing in all over the world and in our country. Paracetamol, diclofenac sodium and opioids are usually used in the fight against post-cesarean pain. Of these drugs, paracetamol is safe after cesarean but has low efficacy and can be side effects to liver in its frequent use. Diclofenac sodium is also an effective drug, but it requires repeated doses and can pass into milk and cause side effects to the kidneys. Opioids have high efficacy, but they can undergo both mother and milk and cause respiratory depression. These drugs used are all systemically administered. We aimed to provide both analgesic effect and reduce the dose of other systemic drugs by using the etofenamate (doline 50 ml) spray locally around the incision. A total of 200 patients who come to our hospital from all parts of Somalia are randomly ordered (single and double) in order to come up with the number 1 spray (ethofenamate spray) to the number 1, 2 to 2 number 2 to the number 2 times to the incision. It will be tightened. The study is planned as double-blind and placebo-controlled. Serum physiologic will be put into spray No. 2. Practitioner assistant and patient box contents will not know. The application will be performed 4 times in total 24 hours postoperatively. All patients will receive paracetamol IV as standard analgesic doses. If analgesic is insufficient, tramadol 50 mg doses will be added and recorded. Visually numerical pain scale (VNS) will perform to both groups at 0-6-12-24. hours. Demographic data, duration of operation, type of anesthesia, need for additional operation, incision size, additional analgesic need, VNS data will be recorded. When sufficient number of patients are reache

Countries

Somalia

Contacts

Public ContactSamaara Hassan

Nurse

samaara010@gmail.com+252615937497

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026