Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia

M

Mansoura University

Status

Completed

Conditions

Postcesarean Analgesia

Treatments

Procedure: Transversus abdominis plane block
Drug: Paracetamol
Procedure: Fentanyl patient-controlled analgesia
Procedure: Cesarean delivery
Drug: Intrathecal fentanyl
Procedure: Wound infiltration
Procedure: Sham procedure
Drug: Intrathecal bupivacaine
Drug: Ketorolac
Procedure: Spinal anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT02691572
R/16.01.17

Details and patient eligibility

About

The study will compare the analgesic efficacy of transversus abdominis plane block and wound infiltration in parturients undergoing cesarean delivery under spinal anesthesia.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

19 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Wound Infiltration
Active Comparator group
Description:
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% will be injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure will be performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia will be administered postoperatively.
Treatment:
Procedure: Spinal anesthesia
Drug: Ketorolac
Procedure: Sham procedure
Drug: Intrathecal bupivacaine
Procedure: Wound infiltration
Drug: Intrathecal fentanyl
Procedure: Fentanyl patient-controlled analgesia
Procedure: Cesarean delivery
Drug: Paracetamol
Transversus abdominis plane block
Experimental group
Description:
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 will be performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia will be administered postoperatively.
Treatment:
Procedure: Spinal anesthesia
Drug: Ketorolac
Drug: Intrathecal bupivacaine
Drug: Intrathecal fentanyl
Procedure: Fentanyl patient-controlled analgesia
Procedure: Cesarean delivery
Drug: Paracetamol
Procedure: Transversus abdominis plane block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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