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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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06602505
Enrollment
220
Registered
2024-09-19
Start date
2023-04-01
Completion date
2024-03-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean Section

Keywords

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

Brief summary

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

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.

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.

Sponsors

Tata Main Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The person assessing the pain scores and the other observation parameters in the postoperative period was blinded to the group to which the patient was assigned.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative back pain90 daysPost 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

MeasureTime frameDescription
Birth weight of the child1 dayBirth weight of the Child was measured at the birth of the baby
Period of gestation (weeks)Weeks between conception and birth when a baby through Caesarean SectionThe period of gestation is the time between conception and birth when a baby through Caesarean Section in this study.
Gravida1 dayGravida 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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026