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

NCT06602505 | Completed

• 1 other identifier: 2222100059
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Caesarean Section

Keywords

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

Outcome Measures

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.

  90 days

Secondary Outcomes (3)

• Birth weight of the child

  1 day

• Period of gestation (weeks)

  Weeks between conception and birth when a baby through Caesarean Section

• Gravida

  1 day

Study Arms (2)

Group B: No-field Block Group

NO INTERVENTION

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.

Group A: Field Block Group

EXPERIMENTAL

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

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.

Group A: Field Block Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only female patients, aged 18-45 years, posted for emergency or elective lower segment cesaerian section surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Tata Main Hospital: lead

Study Sites (1)

Tata Main Hospital

Jamshedpur, Jharkhand, 831011, India

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HOD & Head Consultant Anaesthesiology

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 19, 2024
• Study Start: April 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IN (1)