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Assessment of the effect of intrathecal bupivacaine combined with opioids on postoperative analgesia in patients undergoing cesarean section

Assessment of the effect of intrathecal bupivacaine combined with opioids (morphine, fentanyl) on postoperative analgesia in patients undergoing cesarean section

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001372370
Enrollment
1090
Registered
2017-09-27
Start date
2016-04-01
Completion date
2016-12-30
Last updated
2017-10-02

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

Conditions

None listed

Brief summary

Purpose: Our prospective, randomized, double-blind study aimed to detect the effect of intrathecal bupivacaine combined with opioids on the postoperative analgesia in patients undergoing cesarean section. Material and Methods: 1110 patients with gestational age over 37 weeks, over 18 years of age and who undergoing elective cesarean section with spinal anesthesia were into the following three groups according to intrathecal opioids: Group 1: 8 mg 5% hyperbaric bupivacaine and 20 mcg fentanyl, Group 2: 8 mg 5% hyperbaric bupivacaine and 20 mcg fentanyl + 50 mcg morphine, Group 3: 8 mg 5% hyperbaric bupivacaine and 20 mcg fentanyl + 100 mcg morphine. First analgesic requirement time, intraoperative and postoperative side effects, intraoperative visual analog scale (VAS) were recorded. Results: 1090 patients were included in the statistical evaluation. Intraoperative nausea and vomiting were significantly less in the Group 3 (p=0.047). Intraoperative pruritus was significantly higher in Group 3 compared to the other two groups (p<0.001). There was no difference between the groups in terms of intraoperative VAS values. Postoperative nausea, vomiting, pruritus, hypotension, bradycardia were similar among the groups. Patient satisfaction was lowest in Group 1 and highest in Group 3 (p<0.001). The duration of first analgesia was short in Group 1 (p<0.001). Conclusions: We concluded that, morphine added to bupivacaine and fentanyl for spinal anesthesia increased the duration of the first analgesic requirement and that 50 and 100 mcg of morphine were not superior to each other in terms of side effects and first analgesic duration.

Interventions

The patients ' demographic data were recorded. Patients distributed to groups with closed envelope technique. The patients divided into three groups. according to the administered opioids that they receive: Group II: 8 mg 5% hyperbaric bupivacaine + 20 mcg fentanyl + 50 mcg morphine were administrated intrathecal prior to caesarean procedure by anaesthesiologist Group III: 8 mg 5% hyperbaric bupivacaine + 20 mcg fentanyl + 100 mcg morphine were administrated intrathecal prior to caesarean pr

The patients ' demographic data were recorded. Patients distributed to groups with closed envelope technique. The patients divided into three groups. according to the administered opioids that they receive: Group II: 8 mg 5% hyperbaric bupivacaine + 20 mcg fentanyl + 50 mcg morphine were administrated intrathecal prior to caesarean procedure by anaesthesiologist Group III: 8 mg 5% hyperbaric bupivacaine + 20 mcg fentanyl + 100 mcg morphine were administrated intrathecal prior to caesarean procedure by anaesthesiologist The effectiveness of spinal anesthesia was assessed with the hot-cold sensation test and Bromage scale. The surgery was initiated when the sensorial block level reaches T4 dermatome. Intraoperative pain was monitored using the Visual Analog Scale (VAS). The duration of effective analgesia till the first postoperative analgesic requirements, The additional analgesic requirement within the first 24- hours after the surgery, the amount of additional analgesics, and side effects (nausea, vomiting, pruritus, and headache) were evaluated and recorded.

Sponsors

derya karasu
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

- 18 years older -cesarean section under spinal anesthesia - who know Turkish and are cooperative - whose physical status is consistent with ASA II class -gestational age must be >27 weeks

Exclusion criteria

-neurological disease -preeclampsia, diabetes mellitus, infection on the surgical site, -disorders associated with bleeding/ clotting, severe agitation, -non-cooperation, rejection of regional anesthesia, -obesity (body mass index >35 kg/m2), -height shorter:150 cm, - known fetal abnormality, placenta previa, history of ablatio placentae, risk for growth retardation and meconium aspiration; pathology that may affect the acid-base balance, antepartum hemorrhage, -Rh incompatibility - hypersensitivity to local anesthetics -history of frequent analgesic use - allergy to any medicine in the projected study protocol.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026