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Completed

NCT Number: NCT05136118

Transversus Abdominis Plane Block for Post-operative Analgesia Following Cesarean Section

Postpartum analgesia is a common concern after Cesarean Section (CS). The quality of postoperative recovery is improved by opioid sparing pain control approaches. The transversus abdominis plane block (TAPB) is an effective technique for postpartum analgesia after cesarean section. Pregnancy results in thinning of the internal oblique aponeurosis; with increased incidence of missing the second pop to reach the transversus abdominis plane (TAP). The classic blind approach to the TAP is associated with several complications; so, it has been largely replaced by the ultrasound-guided approach to the TAP. The ultrasound-guided approach to the TAPB was first described by Hebbart and his colleagues in 2007.Ultrasound-guided TAPB improves the success of the block, reduces the volume of local anesthetic used and prevents the potential injury of adjacent structures.

Surgical approach to the TAPB was also described, it is a quick and easy approach of establishing a reliable block. The surgeon performs an intra-abdominal approach to the TAPB; by which asepsis is easily attained, visible and tactile confirmation of correct needle placement may be achieved with no risk of damage to the viscera but care must be given to avoid injury of the inferior epigastric vessels.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain-Shams University

Cairo, Egypt

About this study

Compare the Transversus Abdominis Plane Block via the modified surgeon assisted approach (Study group), to the ultra-sound guided approach (Control group); as regards the post-operative analgesia following Cesarean Section.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status I and ∏
  • primigravidas
  • aged 21-40 years
  • BMI ˂ 40
  • body weight ˃ 60 kg
  • singleton pregnancy
  • gestational age of ≥37 weeks
  • undergoing elective caesarean section under spinal anesthesia.

Exclusion criteria

  • Parturient refusal
  • parturient with a BMI > 40
  • body weight < 60 kg
  • ASA physical status ≥ III
  • known local anesthetic (LA) allergy •contraindications to spinal anesthesia
  • parturients who received analgesics in the past 24 hours
  • infection at the site of the block.

Treatment and study plan

TAPB

Procedure

TAPB will be given to parturients whether by the modified surgeon assisted approach or by the ultra-sound guided approach.

Primary outcomes

  1. Time to rescue analgesia

    Time frame: 6 months

    the time from the end of surgery until the first parturient's request for analgesia

Secondary outcomes

  1. Efficacy of the modified surgeon assisted approach for TAPB on postoperative analgesia

    Time frame: 6 months

    assessment of pain intensity at rest and on passive flexion of the hip and knee by the Numeric Pain Rating Score (NPRS) from 0 = no pain to 10 = worst pain. Assessment will be done at 2, 6, 12 and 24h postoperative.

  2. Number of parturients requiring postoperative analgesia

    Time frame: 6 months

    defined as pethidine needed by each parturient in the 24 hours postoperative period

  3. Total dose of pethidine given

    Time frame: 6 months

    defined as pethidine needed by each parturient in the 24 hours postoperative period

  4. Time to the parturient's first ambulation

    Time frame: 6 months

    the time to start of each parturient movement in the 24 hours postoperative period

  5. The analgesic satisfaction 24 hours after operation

    Time frame: 6 months

    parturients will be asked to report their satisfaction with pain management, assessed as 0 = weak, 1 = medium, 2 = good, 3 = very good, and 4 = excellent.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Transversus Abdominis Plane Block: Ultra-sound Guided Versus the Modified Surgeon Assisted Approaches for Post-operative Analgesia Following Cesarean Section

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2021
Registry last updated
Oct 28, 2022

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.

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