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NCT Number: NCT06602505

Comparative Analysis of Incidence of Newly Developed Postoperative Low Back Pain with Field Block Versus Without Field-block Before Spinal Anaesthesia for Patients Undergoing Caesarean Sections

The study aimed to evaluate the effectiveness of field block in preventing postoperative low back pain (PDPB) in patients undergoing Cesarean Sections.

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Key information

Conditions

Caesarean Section Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tata Main Hospital

Jamshedpur, Jharkhand, 831011, India

About this study

The purpose of this study was to evaluate the effectiveness of field block with lidocaine 2% (5 ml) administered with a 24G hypodermic needle before spinal anesthesia for patients undergoing LSCS, in preventing the development of postoperative low back pain (PDPB). The study aimed to determine if using a field block would decrease the incidence of PDPB compared to patients who received only spinal anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All patients undergoing LSCS under spinal anesthesia, ASA Grade 2 and Grade 2E and willing to participate in the trial

Exclusion criteria

Spine pathology/instability and coagulopathy, ASA Grade 3 and above, Pre-exiting low back pain, Morbid Obesity (BMI > 35), Patients needing more than 1 attempt for administration of spinal anaesthesia, Patients utilizing labour analgesia, Local infection or inflammation at the site of spinal anesthesia/field block, Unwilling to participate

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Treatment and study plan

Group A: Field Block Group

Procedure

Patients received field block with 5ml of 2% Lignocaine using a 24 G hypodermic needle before institution of subarachnoid block using 27 G Quincke's spinal needle for lower segment Caesarean section.

Primary outcomes

  1. Incidence of postoperative back pain

    Time frame: 90 days

    Post operative back pain was assessed using a questionnaire specifically designed to evaluate back pain and transient neurological symptoms (e.g., unilateral or bilateral pain or radicular pain in the buttock, thigh, calves, or legs). Twenty-four hours after surgery, the patients were assessed for incidence and level of low back pain. In patients with back pain, the characteristics, aggravating factors, and degree of back pain was assessed using a numeric NRS. The same questionnaire was used telephonically to assess pain at 7 days, 1 month and 3 months after surgery.

Secondary outcomes

  1. Birth weight of the child

    Time frame: 1 day

    Birth weight of the Child was measured at the birth of the baby

  2. Period of gestation (weeks)

    Time frame: Weeks between conception and birth when a baby through Caesarean Section

    The period of gestation is the time between conception and birth when a baby through Caesarean Section in this study.

  3. Gravida

    Time frame: 1 day

    Gravida at the time of Caesarean. It refers to a woman who is pregnant or has been pregnant in the past, regardless of the outcome of the pregnancy.

Sponsors and collaborators

Lead sponsor

Tata Main Hospital

Other

Registry information

Official study title

Comparative Analysis of Incidence of Newly Developed Postoperative Low Back Pain with Field Block Versus Without Field-block Before Spinal Anaesthesia for Patients Undergoing Caesarean Sections.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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