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The Analgesic Efficacy of Wound Infiltration With Tramadol

A Randomized Trial of the Analgesic Efficacy of Wound Infiltration With Tramadol After Cesarean Delivery Under General Anesthesia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02518438
Enrollment
60
Registered
2015-08-07
Start date
2012-05-31
Completion date
2013-05-31
Last updated
2015-08-07

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

Conditions

Postoperative Pain

Keywords

Tramadol, Postoperative analgesia, Infiltration, Cesarean section

Brief summary

This double-blind, randomized trial examined whether tramadol wound infiltration decreased postoperative pain following cesarean delivery under general anesthesia or reduced the need for analgesics in the immediate postoperative period. Patients in the tramadol group consumed significantly less morphine at all time intervals than those in the control group. The investigators suggest that the use of wound infiltration with tramadol may be a useful technique in patients who undergo cesarean section under general anesthesia to reduce postoperative pain, improve recovery, and facilitate early contact of mothers with their babies.

Interventions

DRUGTramadol

A preprepared 20 ml solution was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.

Sponsors

Yeditepe University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Nulliparity * Gestation age between 37-40 weeks * CS under general anesthesia

Exclusion criteria

* Pre-eclampsia * Cardiovascular problems * Allergy to any of the study medications * Chronic preoperative pain * Regular analgesic use

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome measure in this study was cumulative morphine consumption.postoperative 24 hoursThe measure of need for analgesics in the immediate postoperative period in this study was cumulative morphine consumption.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026