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CompletedNCT06602505Updated Sep 19, 2024

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

An interventional study of Group A: Field Block Group in Caesarean Section, sponsored by Tata Main Hospital. Completed at 1 site in India. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Tata Main Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Apr 2023, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Caesarean Section

Keywords

  • Cesarean Section
  • Back Pain
  • Anesthesia, Local
  • Anesthesia, Spinal
  • Lidocaine
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 220 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Tata Main Hospital is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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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05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • No intervention
    Group B: No-field Block Group

    Group B did not receive any field block before institution of subarachnoid block using 27 G Quincke's spinal needle for lower segment Caesarean section.

  • Experimental
    Group A: Field Block Group

    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.

    Procedure: Group A: Field Block Group

Interventions

  • ProcedureGroup A: Field Block Group

    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.

06

What researchers measure

Primary outcomes

  1. Incidence of postoperative back pain

    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.

    Time frame: 90 days

Secondary outcomes

  1. Birth weight of the child

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

    Time frame: 1 day

  2. Period of gestation (weeks)

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

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

  3. Gravida

    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.

    Time frame: 1 day

07

Study locations

1 site
  • Tata Main Hospital
    Jamshedpur, Jharkhand 831011, India
08

References and documents

Individual participant data

Plan to share: Undecided — Being a GDPR compliant organization, permission of the Data Security Officer has to be obtained. However, masked data may be considered and provided if approved by the organization.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06602505
Lead sponsor
Tata Main Hospital
Responsible party
Dr.Deb Sanjay Nag (HOD & Head Consultant Anaesthesiology, Tata Main Hospital) — Principal investigator
First posted
Sep 19, 2024
Start date
Apr 1, 2023
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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