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

Not Applicable

Completed

• Conditions: Caesarean Section

• Registration Number: NCT06602505
• Lead Sponsor: Tata Main Hospital

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.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-09
• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-15
• Last Update Submitted: 2024-09-15
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative back pain	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 Outcome Measures

Name	Time	Method
Birth weight of the child	1 day	Birth 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 Section	The period of gestation is the time between conception and birth when a baby through Caesarean Section in this study.
Gravida	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.

Trial Locations

Locations (1)

Tata Main Hospital; 🇮🇳 Jamshedpur, Jharkhand, India