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The analgesic efficacy of a low dose of bupivacaine plus fentanyl versus a conventional dose of bupivacaine plus fentanyl for subarachnoid anaesthesia during caesarean section

The analgesic efficacy of a low dose of bupivacaine plus fentanyl versus a conventional dose of bupivacaine plus fentanyl for subarachnoid anaesthesia during caesarean section: A controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16067539
Enrollment
65
Registered
2011-02-28
Start date
2010-07-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Caesarean section-spinal anaesthesia Pregnancy and Childbirth Delivery by caesarean section

Interventions

The patients that met the inclusion criteria were assigned to one of the two comparison groups by a random number table: 1. Group 1 received 7.5 mg of hyperbaric bupivacaine 0.5% plus 25 µg of fentan

Sponsors

Neiva City University Hospital (Colombia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pregnant patients over 18 years with an indication of caesarean section 2. ASA II patient

Exclusion criteria

Exclusion criteria: 1. Patient who refused to enter the study 2. Patients with known hypersensitivity to any of the anesthetic agents used in the study 3. Patients with contraindication to spinal block 4. Procedures lasting more than an hour 5. Patients with multiple pregnancy or premature birth 6. Patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) and / or opioids intravenous(IV) in the last 4 hours

Design outcomes

Primary

MeasureTime frame
1. The maternal side effects 2. Intraoperative pain 3. Onset time for motor and sensory block, motor block level, maximum level of sensory block, patient and obstetrician satisfaction. The assessment of sensory block was made by prick and thermal sensitivity, while motor block was evaluated using the Bromage scale 3.1. I-patient moves only the legs, 3.2. II- Patient moves only the feet 3.3. III- The knees flex 3.4 IV-patient raises and extends the legs . This evaluation was performed at 5, 10, and 15 minutes with the medicine cord. 4. For transitional analgesia, 50 mg / k doses of dipyrone were administered intraoperatively. If anesthetic effects were not properly observed (absence of sensory and motor block), the procedure was repeated with the same dose. In cases of inadequate anesthesia (presence of surgical pain after 20 minutes) or cases in which the patient?s discomfort or inconvenience was related to manipulation of the uterus, the patient was administered a fentanyl bolus of 50 µg then two bowls by IV. If full pain management was not achieved, the general anesthetic technique was used.

Secondary

MeasureTime frame
1. Patient and obstetrician satisfactions were defined as satisfied, moderately satisfied, very satisfied or unsatisfied 2. Postoperative pain was evaluated at two and six hours after operation by a verbal numerical scale (0-10, with 0 indicating no pain and 10 indicating excruciating pain). If the patient indicated a number greater than 5, a 4 mg / k dose of morphine was added via IV.

Countries

Colombia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026