Comparison study to know whether injection paracetamol is effective in decreasing pain as compared to femoral nerve block( injection for nerve carrying pain from leg) during patient positioning for central neuraxial block(injection to back of patient for pain relief) in leg bone fracture surgeries

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2021/07/035052

Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research

Brief Summary: Central neuraxialblocks (combined spinal epidural blocks) are one of the preferred techniques foranaesthetising patients posted for orthopaedic surgeries for fracture femur fixation. Positioning these patients for neuraxial blockadehowever is rendered very difficult due to the pain of fracture. Suboptimal positioning sometimes leads to prolongedduration and in some cases lead to block failure as well. It alsocauses severe pain and discomfort to the patients which may result in haemodynamicdistubances including tachycardia and hypertension.

Femoral nerve block has been shown to be an effectivemethod of analgesia for spinal positioning in patients with fractured femoral shaftand proximal femur fractures. Several drugsincluding opioids have also been employed for this purpose and had been comparedwith femoral nerve block.but use of opioids has disadvantages of causing drowsinessand respiratory depression. Paracetamol is a nonopioid analgesic and is one of thecommonly used analgesic agent that had been used in various acute pain conditionsincluding postoperative pain .Intravenous paracetamol is the formulation which ispreferred in the perioperative period due to its increased bioavailability and isalmost safe in all age groups and is easilyaccessible. The main advantage of paracetamol is that it is easilyadministrable as compared to blocks.In this study we like to compare the efficacyof femoral nerve block and intravenous paracetamol given in the preoperative period,in improving conditions of positioning required for cental neuraxial block.

Eventhough paracetamol has been studied as an analgesic in intraoperative and postoperativeperiod, its usefulness in the preoperative period for the purpose of providing analgesiafor patient positioning for central neuraxial block in patients with femur fracturehas not been studied. Intravenousparacetamol if it is found to be effective in providing adequate analgesia and providingoptimal conditions for patient positioningduring performance of central neuraxial block can be used routinely for this purposepreoperatively in patients with fracture femur posted for surgery

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 56

Inclusion Criteria

Patients of age above 18 years,and classified as ASA physical status 1-3, undergoing surgery for femur fracture fixation.

Exclusion Criteria

Allcontraindications for central neuraxial block like localised sepsis,allergy to drugs,raised intracranial pressure,coagulopathy ,pregnancy and hepatic or renal impairment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of analgesic efficacy of femoral nerve block versus intravenous paracetamol during positioning for central neuraxial block in patients with femur fractures	VAS scores will be assessed during patient positioning for central neuraxial blockage
between group P(intravenous paracetamol) and group F( femoral nerve blockage ) using visual analogue pain Scale (VAS score).	VAS scores will be assessed during patient positioning for central neuraxial blockage

Secondary Outcome Measures

Name	Time	Method
Comparison of the quality of patient position in likerts scale as perceived by the anaesthesiologist performing the central neuraxial block between both the groups.	During patient positioning for central neuraxial blockage
Comparison of the total time taken for performance of the block in both the groups.	Time taken for central neuraxial block will be compared
Comparison of hemodynamic parameters(pulse rate and blood pressure)during the positioning of the patient in both groups.	During patient positioning for central neuraxial blockage
Comparison of the rescue fentanyl dose used during the procedure to alleviate the pain in both the groups.	if patient still has VAS score greater than 4 during positioning even after intravenous paracetamol(group P) or femoral nerve block(group F)

Trial Locations

Locations (1): Jawaharlal institute of post graduate medical education and research
🇮🇳
Pondicherry, PONDICHERRY, India
Jawaharlal institute of post graduate medical education and research
🇮🇳Pondicherry, PONDICHERRY, India
Dr Srinivasan S
Principal investigator
9626493045
jipmersrinivasan@gmail.com