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

NCT05136118 | Completed

• 1 other identifier: R 86/2021
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia

Keywords

post-operative analgesia; Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

• Time to rescue analgesia

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

  6 months

Secondary Outcomes (5)

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

  6 months

• Number of parturients requiring postoperative analgesia

  6 months

• Total dose of pethidine given

  6 months

• Time to the parturient's first ambulation

  6 months

• The analgesic satisfaction 24 hours after operation

  6 months

Study Arms (2)

Group MS

ACTIVE COMPARATOR

The modified surgeon assisted approach for TAPB Before the closure of the peritoneum, TAPB will be performed; at the level of the umbilicus 8 to 10cms from the midline bilaterally. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin slightly directed towards the ipsilateral anterior superior iliac spine. After feeling the 2 pops of the external and the internal oblique aponeurosis by the anesthesiologist, the surgeon will confirm proper needle placement by his hand inside the abdominal cavity. The LA will be injected after negative aspiration and a bleb will be palpated by the surgeon as the injection continues. The same procedure will be repeated on the other side.

Procedure: TAPB

Group US

ACTIVE COMPARATOR

The ultra-sound guided approach for TAPB. After abdominal wall closure, the linear probe of the ultra- sound will be placed perpendicular to the skin at the mid-axillary line between the iliac crest and the costal margin; the TAP will be located between the internal oblique and the transversus abdominis muscle. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin and the 2 pops of the external and the internal oblique aponeurosis will be also felt. The LA will be injected after negative aspiration and its spread in the plane will be observed. The same procedure will be repeated on the other side.

Procedure: TAPB

Interventions

TAPB PROCEDURE

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

Group MS; Group US

Eligibility Criteria

• Age: 21 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropane

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, Intensive care and Pain Management

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 29, 2021
• Study Start: November 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: October 25, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)