To study the effect of two regional anesthesia techniques for adequate pain control after surgeries around hip joint

Completed

Conditions: Osteoarthritis of hip, unspecified,

Registration Number: CTRI/2021/09/036787

Lead Sponsor: AIIMS Jodhpur

Brief Summary: Pre-anaesthetic evaluation will bedone for all the patients, a day before surgery. All patients will bethoroughly explained about the procedure. They will also be made wellconversant about the Numeric Rating Scale (NRS) ranged from 0 to 10 (0 = nopain and 10 = worst imaginable pain). The standard instruction of fasting willbe given to all patients (2 hours for clear liquids and 6 hours for semisolidand solid food).

On arrival of the patient inpreoperative holding area, patient identification, fasting status, consent, andPAC will be confirmed. In the procedure room, standard ASA monitors likeelectrocardiogram (ECG), non-invasive blood pressure (NIBP) pulse oximetry willbe attached and baseline vitals will be recorded. A peripheral intravenouscannula will be secured in ipsilateral upper limb and intravenous fluids willbe started. All patients will receive combined spinal epidural (CSE). Epiduralspace will be identified using loss of resistance to saline subarachnoid blockwill be performed using needle through needle technique with bupivacaine 0.5%heavy 15 mg. Epidural catheter will be secured and a test dose (3 mL oflignocaine 1.5% with 5 mcg/mL epinephrine) will be administered through thecatheter. Following CSE, one of the intervention techniques as perrandomization will be performed.

Following theblock patients will undergo the scheduled surgery. During the surgery vitals[heart rate (HR), mean arterial pressure (MAP), oxygen saturation (SpO2)and temperature] will be recorded. No further analgesics will be administeredduring the surgery. After completion of surgical procedure, patients will beshifted to PACU.

Postoperative analgesia will be assessedusing NRS immediately after receiving the patient in the PACU and thereafter at1-hour, 3-hours, 6-hours, 12-hours, 18-hours and at 24-hours. On recording ofNRS â‰¥4 or on patient demand rescue analgesia (10 mL 0.2% ropivacaine) throughepidural catheter will be administered and time to rescue analgesia will berecorded. Total epidural boluses during the observation period will also berecorded.

The motor blockade will be assessed atpredefined time interval by testing the quadriceps motor function with thepatient supine and with the hip and knee flexed at 45Âº and 90Âº, respectively.The patient will be asked to extend the knee first against gravity and thenagainst resistance. Quadriceps strength will be graded according to a 3-pointscale: normal strength = 0 point (extension against resistance); paresis = 1point (extension against gravity but not against resistance); and paralysis = 2points (no extension).

Patient satisfaction will be recorded on afour-point Likertâ€™s scale as 1- excellent; 2- good; 3- fair and 4- poor.

Block performance time defined as timeinterval between putting the ultrasound probe and completion of LA agent.

Periproceduralcomplication like vascular puncture, paresthesia, systemic LA toxicity etc willbe recorded.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 58

Inclusion Criteria

Belonging to American Society of Anesthesiologists Physical Status 1-3 and Scheduled for elective unilateral total hip replacement surgery.

Exclusion Criteria

1.Known hypersensitivity to any of the drugs used in the study.
Patient having infection at the site of block.
Patients with coagulopathy or on anticoagulation therapy.
4.Patients with untreated psychiatric illness.
5.Patients with known cardiac, hepatic or kidney diseases.
6.Opioid Dependency 7.Pre-existing neurologic or anatomic deficits in the lower extremities 8.Prior surgery in the corresponding side of the inguinal or suprainguinal area 9.Chronic pain syndromes requiring opioid intake at home 10.Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative pain relief assessed by Numeric Rating Scale (NRS) at fixed time interval	First 24 postoperative hours

Secondary Outcome Measures

Name	Time	Method
1. Motor Blockade at fixed time interval	2. The time of first rescue analgesic requirement.

Trial Locations

Locations (1): AIIMS, Jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
AIIMS, Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
Sadik Mohammed
Principal investigator
drmsadik@gmail.com