Postcesarean Analgesia
Conditions
Brief summary
The study will compare the analgesic efficacy of transversus abdominis plane block and wound infiltration in parturients undergoing cesarean delivery under spinal anesthesia.
Detailed description
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Patients will receive either ultrasound-guided transversus abdominis plane block or wound infiltration at the end of surgery. After delivery, all patients will receive standard analgesia (intravenous ketorolac and oral paracetamol) and patient-controlled analgesia with intravenous fentanyl. Total fentanyl consumption at 24 h, pain scores at 2, 4, 6, 12, and 24 h, side effects, and patient satisfaction will be compared between the 2 groups.
Interventions
PROCEDURECesarean delivery
Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.
PROCEDURESpinal anesthesia
Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.
Bupivacaine 12.5 mg will be administered in the subarachnoid space.
Fentanyl 15 µg will be administered in the subarachnoid space.
PROCEDUREWound infiltration
30 mL bupivacaine 0.25% will be injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing.
PROCEDURESham procedure
Sham procedure will be performed after surgery by moving the ultrasound probe and pressing a covered spinal needle on both sides of the patients' abdomen.
PROCEDURETransversus abdominis plane block
Bilateral ultrasound-guided TAP block using 20 mL bupivacaine 0.25% on each side. A 7-12 MHz linear array probe and 22-gauge needle will be used. The probe will be placed transversely above the iliac crest in the anterior axillary line and the needle will be introduced in-plane with the probe from medial to lateral.
DRUGKetorolac
IV ketorolac 30 mg/8 h starting at the end of surgery.
DRUGParacetamol
Oral paracetamol 1 gm/8 h starting 4 h after surgery.
PROCEDUREFentanyl patient-controlled analgesia
Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesiologists physical status II 2. Full-term singleton pregnancy
Exclusion criteria
1. Age \<19 or \> 40 years 2. Height \<150 cm 3. Weight \<60 kg 4. Body mass index ≥40 kg/m2 5. Contraindications to spinal anesthesia (patient refusal, increased intracranial tension, coagulopathy, uncorrected hypovolemia) 6. Hypersensitivity to any of the drugs used in the study 7. Significant cardiovascular, renal, or hepatic disease 8. Known fetal abnormalities 9. Emergency situations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative Fentanyl Dose | 24 h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the First Postoperative Fentanyl Administration | 24 h | — |
| Pain Scores at Rest and Movement | 2, 4, 6, 12, and 24 h | Assessed using 11-point verbal rating scale (0 = no pain, 10 = the worst possible pain), at rest and movement. |
| Number of Patients With Nausea and/or Vomiting | 24 h | The occurrence of nausea and/or vomiting will be observed and recorded. |
| Cumulative Fentanyl Dose | 2, 4, 6, 12 h | — |
| Number of Patients With Pruritis | 24 h | The occurrence of pruritis will be assessed by yes/no question and recorded. |
| Level of Patient Satisfaction | 24 h | Assessed at 24 h using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, 5 = very satisfied). |
| Level of Sedation | 24 h | Assessed using a 4-point scale (1 = awake and alert, 2 = minimally sedated, responds to speech, 3 = moderately sedated, rousable by tactile stimulation, 4 = deeply sedated, rousable only with painful stimulation). |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wound Infiltration Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively | 39 |
| Transversus Abdominis Plane Block Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively | 39 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Wound Infiltration | Transversus Abdominis Plane Block | Total |
|---|---|---|---|
| Age, Continuous | 26.2 years STANDARD_DEVIATION 4.4 | 26.7 years STANDARD_DEVIATION 4.1 | 26.4 years STANDARD_DEVIATION 4.2 |
| Body mass index | 32.3 kg/m^2 STANDARD_DEVIATION 3.7 | 31 kg/m^2 STANDARD_DEVIATION 3.3 | 31.7 kg/m^2 STANDARD_DEVIATION 3.6 |
| Gestational age | 38 weeks | 38 weeks | 38 weeks |
| Height | 163 cm STANDARD_DEVIATION 6 | 162 cm STANDARD_DEVIATION 4 | 163 cm STANDARD_DEVIATION 5 |
| Nulliparous | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Female | 39 Participants | 39 Participants | 78 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 86 kg STANDARD_DEVIATION 13 | 81.8 kg STANDARD_DEVIATION 9.2 | 83.9 kg STANDARD_DEVIATION 11.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
Cumulative Fentanyl Dose
Time frame: 24 h
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wound Infiltration | Cumulative Fentanyl Dose | 157.4 mcg | Standard Deviation 63.4 |
| Transversus Abdominis Plane Block | Cumulative Fentanyl Dose | 153.3 mcg | Standard Deviation 68.3 |
Secondary
Cumulative Fentanyl Dose
Time frame: 2, 4, 6, 12 h
Secondary
Level of Patient Satisfaction
Assessed at 24 h using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, 5 = very satisfied).
Time frame: 24 h
Secondary
Level of Sedation
Assessed using a 4-point scale (1 = awake and alert, 2 = minimally sedated, responds to speech, 3 = moderately sedated, rousable by tactile stimulation, 4 = deeply sedated, rousable only with painful stimulation).
Time frame: 24 h
Secondary
Number of Patients With Nausea and/or Vomiting
The occurrence of nausea and/or vomiting will be observed and recorded.
Time frame: 24 h
Secondary
Number of Patients With Pruritis
The occurrence of pruritis will be assessed by yes/no question and recorded.
Time frame: 24 h
Secondary
Pain Scores at Rest and Movement
Assessed using 11-point verbal rating scale (0 = no pain, 10 = the worst possible pain), at rest and movement.
Time frame: 2, 4, 6, 12, and 24 h
Secondary
Time to the First Postoperative Fentanyl Administration
Time frame: 24 h