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NCT Number: NCT05831501

Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

Transverse abdominis plane (TAP) block is an effective method to manage postoperative pain in patients with midline abdominal wall incisions. It is used frequently in many lower abdominal surgeries however its use after caesarean section is still new, and fewer studies are available. We conducted this study to see the analgesic effect of TAP block after caesarean section.

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Key information

Conditions

Post Operative Pain Agnosia Cesarean Section Complications Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Combined Military Hospital

Sargodha, Punjab Province, Pakistan

About this study

The study is being conducted, at Combined Military Hospital Sargodha, Pakistan, to compare the analgesic efficacy of TAP block in providing post-caesarean analgesia with the control group, in terms of mean postoperative use of opioids after caesarean delivery. Sixty patients have been randomly selected using non-probability, consecutive sampling, and applying inclusion and exclusion criteria. The study design is a randomized controlled trial with thirty patients in each group undergoing elective caesareans. All patients will be given spinal anaesthesia with 1.5ml of 0.75% hyperbaric bupivacaine for a caesarean section. Patients in Group A will receive bilateral TAP block with 20ml of 0.25% bupivacaine while 20 ml of saline will be injected in patients of Group B on both sides of midline after caesarean section, in addition to intravenous ketorolac 8hrly. The intensity of pain, total opioid consumption, presence of vomiting, and sedation will be noted until 24 hours after the surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Elective Caesarean section
  • ASA 1-3
  • 20yrs to 45yrs

Exclusion criteria

  • Emergency Surgery
  • known allergy to local anaesthetic
  • severe pre-eclampsia
  • placenta accreta
  • ASA 4
  • Coagulopathy
  • Hemodynamically unstable

Treatment and study plan

Trans abdominis plane block

Procedure

Ultrasound guided infiltration of local anaesthetic bupivacaine via 22G Quincke needle between internal oblique and trans abdominis muscle layers in abdominal wall.

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: 24 hours post cesarean section

    within 24hours after surgery

Secondary outcomes

  1. Pain intensity Score

    Time frame: from end of secarean section till 24 post operative hours

    Pain intensity at 6 hours,12 hours and 24 hours after surgery

  2. Vomiting

    Time frame: Within 24hours after surgery

    frequency of vomiting within 24hours after surgery

  3. Duration of First Rescue Analgesia

    Time frame: Within 24hours after surgery

    time after surgery when first dose of opioid required

Sponsors and collaborators

Lead sponsor

Armed Forces Hospital, Pakistan

Other

Registry information

Official study title

Postoperative Analgesic Efficacy of Trans Abdominis Plane Block in Women Undergoing Caesarean Section, a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2023
Registry last updated
Apr 26, 2023

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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