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

ISRCTN	ISRCTN16067539
DOI	https://doi.org/10.1186/ISRCTN16067539
Protocol serial number	U1111-1119-4404
Sponsor	Neiva City University Hospital (Colombia)
Funder	Investigator initiated and funded (Colombia)

Submission date: 12/02/2011
Registration date: 28/02/2011
Last edited: 28/02/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Jorman Harvey Tejada Perdomo
Scientific

cr 8 b 30-84 103 apartment block 5
Neiva
41001000
Colombia

Study information

Primary study design	Interventional
Study design	Prospective single-centre randomised double-blind study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study objectives	The efficacy of postoperative analgesia with low dose is better (in duration, sensory level and satisfaction) than presented with 12.5 mg hyperbaric bupivacaine plus fentanyl 25 mcg in regional subarachnoid technique for caesarean procedures in patients of american society of anaesthesiologists (ASA) II Neiva hospital. Intraoperative maternal side effects of hyperbaric bupivacaine 7.5 mg plus fentanyl 25 mcg are less than 12.5 mg hyperbaric bupivacaine plus fentanyl 25 mcg in regional subarachnoid technique for caesarean section procedures in ASA II patients at the hospital of Neiva. This trial was designed to compare low doses of hyperbaric bupivacaine with fentanyl versus conventional doses in several respects: haemodynamic stability, pain, intra operative comfort and satisfaction with the use of different concentrations.
Ethics approval(s)	Bioethics committee of the University Hospital of Neiva approved on May 14th 2010, ref no:026
Health condition(s) or problem(s) studied	Caesarean section-spinal anaesthesia
Intervention	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 fentanyl 2. Group 2 received 12.5 mg of hyperbaric bupivacaine 0.5% plus 25 µg of fentanyl For both groups, the total solution volume was 3 ml. Group 1 was supplemented with 1 ml of saline. The drug was prepared by a chemical pharmacy and a second person was designated to the group to make the markings on the syringes. Neither the anaesthesiologist who performed the procedure and readied the syringe nor the research team knew the drug supplied. On admission to the surgical ward, patients were monitored with non-invasive blood pressure (NIBP), electrocardiogram (ECG) at D II derivation, heart rate measurements, pulse oximetry, and respiratory rate measurements and supplemental oxygen was administered via a nasal cannula at 2 liter per minute. All patients received load of 7 ml / kg of 0.9% normal saline solution (SSN) or Ringers lactate in 10-15 minutes. Patients were placed in a sitting position and a 26 G Quincke needle was inserted at the L3-4 interspace by a medial or paramedial approach. Asepsis was ensured by performing antisepsis at the lumbar region. Clear cerebrospinal fluid was injected with an anesthetic solution at a rate of 1 ml/25 s bubbling. After the injection, the position of the needle was confirmed by aspiration of 0.5 ml of CSF and re-injected. The patient was immediately accommodated in a supine neutral position by passing the uterus 15 degrees to the left using a wedge. Maintenance was performed with 0.9% SSN or Ringer's lactate at 10 ml / kg / h. If the mean arterial pressure decreased by more than 20% compared to baseline levels or systolic blood pressure reached levels below 90 mmHg, ephedrine was administered by IV at a dose of 5-10 mg. If this dose failed to anesthetise, etilefrine or phenylephrine was administered at a dose of 50-100 µg. If the heart rate reached levels below 50 beats per minute, then the patient was given atropine at a dose of 0.01 to 0.02 mg/k.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	bupivacaine, fentanyl
Primary outcome measure(s)	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 patients 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.
Key secondary outcome measure(s)	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.
Completion date	31/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	65
Key inclusion criteria	1. Pregnant patients over 18 years with an indication of caesarean section 2. ASA II patient
Key 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
Date of first enrolment	01/07/2010
Date of final enrolment	31/10/2010

Locations

Countries of recruitment

Colombia

Study participating centre

cr 8 b 30-84 103 apartment block 5

Neiva
41001000
Colombia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes