Intraoperative Pain
Conditions
Brief summary
Pregnant women scheduled for elective cesarean sections under spinal anesthesia are randomly assigned to two groups: 1) the Fentanyl-Morphine (FM) group, and 2) the Morphine (M) group. In addition to 11.5 mg of bupivacaine, the FM group receives 15 μg of fentanyl and 50 μg of morphine intrathecally, while the M group receives 50 μg of morphine intrathecally. The incidence of intraoperative pain with a Numerical Rating Scale (NRS) score of 4 or higher is compared between the two groups to evaluate the analgesic effects of combined intrathecal fentanyl-morphine therapy versus morphine alone.
Interventions
DRUGFentanyl-Morphine
Intrathecal injection of bupivacaine, fentanyl and morphine
DRUGMorphine
Intrathecal injection of bupivacaine and morphine
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Parturients of gestational age \> 37 weeks, scheduled for cesarean section under spinal anesthesia
Exclusion criteria
* Contraindication to spinal anesthesia * Any sign of onset of labor * Emergency cesarean section * Body weight \< 40 kg or \> 120 kg * Height \< 140 cm or \> 190 cm * Severe underlying cardiovascular disease * Known fetal anomaly * Preeclampsia * History of hypersensitivity to fentanyl or morphine * Chronic opioid use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative pain | From first skin incision to end of surgery | Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of occurence of intraoperative pain | From first skin incision to end of surgery | Time of occurence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher |
| Total amount of intraoperative opioid rescue analgesic administration | From first skin incision to end of surgery | Total amount of intraoperative opioid rescue analgesic administration (morphine mg equivalent) |
| Total amount of intraoperative non-opioid rescue analgesic administration | From first skin incision to end of surgery | Total amount of intraoperative non-opioid rescue analgesic administration (mg) |
| Intraoperative pain characteristics | From first skin incision to end of surgery | Intraoperative pain characteristics |
| Conversion to general anesthesia | From first skin incision to end of surgery | Conversion to general anesthesia |
| Preoperative anxiety | On the day before surgery | Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score) |
| Total amount of postoperative opioid analgesic administered | From end of surgery to 24 hours after end of surgery | Total amount of postoperative opioid analgesic administered (morphine mg equivalent) |
| Incidence of intraoperative nausea/vomiting | From induction to end of surgery | Incidence of intraoperative nausea/vomiting |
| Incidence of postoperative nausea/vomiting | From end of surgery to 24h post-surgery | Incidence of postoperative nausea/vomiting |
| Incidence of intraoperative shivering | From induction to end of surgery | Incidence of intraoperative shivering |
| Incidence of intraoperative hypotension | From induction to end of surgery | Incidence of intraoperative hypotension (MBP\<65 mmHg) |
| Incidence of intraoperative rescue analgesic administration | From first skin incision to end of surgery | Incidence of intraoperative rescue analgesic administration |
| Incidence of postoperative pruritus | From end of surgery to 24h post-surgery | Incidence of postoperative pruritus |
| Immediate post-operative patient satisfaction | At the end of surgery | Immediate post-operative patient satisfaction on intraoperative analgesia |
| Obstetric Quality of Recovery-11K score | At 24 hours post-surgery | Obstetric Quality of Recovery-11K score |
| Time of first postoperative pain | From end of surgery to 24 hours post-surgery | Time of first postoperative pain |
| Pain score at 8 hours post-surgery | at 8 hours post-surgery | Pain score at 8 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain) |
| Pain score at 16 hours post-surgery | at 16 hours post-surgery | Pain score at 16 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain) |
| Pain score at 24 hours post-surgery | at 24 hours post-surgery | Pain score at 24 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain) |
| Pain score at 2 hours post-surgery | at 2 hours post-surgery | Pain score at 2 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain) |
| Incidence of postoperative hypotension | From end of surgery to 24 hours post-surgery | Incidence of postoperative hypotension (MBP<65 mmHg) |
| Incidence of postoperative shivering | From end of surgery to 24 hours post-surgery | Incidence of postoperative shivering |
| 24-hour post-operative patient satisfaction | at 24 hours post-surgery | 24-hour post-operative patient satisfaction on postoperative analgesia |
| Incidence of intraoperative pruritus | From induction to end of surgery | Incidence of intraoperative pruritus |
Contacts
Primary ContactJin-Tae Kim, M.D., Ph.D
Outcome results
None listed