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NCT Number: NCT02691572

Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia

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

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Key information

Conditions

Postcesarean Analgesia

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists physical status II
  • Full-term singleton pregnancy

Exclusion criteria

  • Age <19 or > 40 years
  • Height <150 cm
  • Weight <60 kg
  • Body mass index ≥40 kg/m2
  • Contraindications to spinal anesthesia (patient refusal, increased intracranial tension, coagulopathy, uncorrected hypovolemia)
  • Hypersensitivity to any of the drugs used in the study
  • Significant cardiovascular, renal, or hepatic disease
  • Known fetal abnormalities
  • Emergency situations

Treatment and study plan

Spinal anesthesia

Procedure

Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.

Intrathecal Bupivacaine

Drug

Bupivacaine 12.5 mg will be administered in the subarachnoid space.

Intrathecal Fentanyl

Drug

Fentanyl 15 µg will be administered in the subarachnoid space.

Cesarean Delivery

Procedure

Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.

Wound Infiltration

Procedure

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

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.

transversus abdominis plane block

Procedure

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.

Ketorolac

Drug

IV ketorolac 30 mg/8 h starting at the end of surgery.

Paracetamol

Drug

Oral paracetamol 1 gm/8 h starting 4 h after surgery.

Fentanyl patient-controlled analgesia

Procedure

Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.

Primary outcomes

  1. Cumulative Fentanyl Dose

    Time frame: 24 h

Secondary outcomes

  1. Cumulative Fentanyl Dose

    Time frame: 2, 4, 6, 12 h

  2. Time to the First Postoperative Fentanyl Administration

    Time frame: 24 h

  3. Pain Scores at Rest and Movement

    Time frame: 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.

  4. Number of Patients With Nausea and/or Vomiting

    Time frame: 24 h

    The occurrence of nausea and/or vomiting will be observed and recorded.

  5. Level of Sedation

    Time frame: 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).

  6. Number of Patients With Pruritis

    Time frame: 24 h

    The occurrence of pruritis will be assessed by yes/no question and recorded.

  7. Level of Patient Satisfaction

    Time frame: 24 h

    Assessed at 24 h using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, 5 = very satisfied).

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Comparison Between Transversus Abdominis Plane Block and Wound Infiltration for Analgesia After Cesarean Delivery

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 25, 2016
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.