Post operative image guided pain relief with local anaesthesia in patients undergoing open nephrectomy

Not Applicable

Completed

Conditions: Other specified disorders of kidney and ureter,

Registration Number: CTRI/2020/09/027996

Lead Sponsor: Himalayan Institute of Medical Sciences

Brief Summary: Post operative pain is a major concern after any surgery. Inadequate control of post operative pain is associated with a delay in recovery leading to an increase in incidence of chronic pain. An adequate post operative analgesia allows for early ambulation thereby reducing risks associated with long hospital stay and ultimately leading to enhanced recovery after surgery. While numerous methods exist for post operative pain management, a single modality of approach remains ineffective.

Patients undergoing renal surgeries often have impaired renal functions and require judicious use of systemic analgesics. In the post operative period, patients undergoing nephrectomy are often managed with either opioids or epidural analgesia. In such scenarios, multimodal analgesia is a better choice since it is associated with reduced opioid requirement and its adverse effects.

The ultrasound guided Erector Spinae Plane Block is a newer regional anaesthesia technique being currently explored as a viable option for analgesia. it is performed by injecting local anaesthetic in the plane between the rector spinae muscle and transverse process. The transverse process is easily identifiable and at a relative distance from any major vascular or neural structures. The local anaesthetic diffuses into paravertebral spaces between adjacent vertebrae and blocks both the dorsal and ventral branches of thoracic spinal nerves thus providing extensive analgesia with a single puncture.

Keeping in mind a multimodal approach to postoperative pain and the ease of adminstration of the Erector Spinae Plane Block, this study is being planned with the view that ultrasound guided erector spinae plane black and intravenous patient contolled analgesia have an additive effect on postoperative pain management and would enable enhanced recovery after surgery and decrease post operative analgesic consumption in patients undergoing open nephrectomy.

**SAMPLE SIZE**

Thesample size was determined by using the NRS to compare the effectiveness byassuming a difference of 1 in NRS between the two groups (group1 and group 2 ) asclinically significant, thus sample size of 24 patients per group wereconsidered necessary to detect statistical significance with an effect size of1.0 at alpha 0.05 and power of 90%

The formula for calculated sample size isgiven below

n= (Ïƒ12 + Ïƒ2 ) . (Z Î± + ZÎ²) 2

(M1 - M2) 2

=(12 + 12).(1.96+1.64)2

(1) 2

= (1+1)\*12.96

1

= 24

whereZÎ±/2 is the critical value of the Normal distribution at Î±/2 (e.g. for aconfidence level of 95%, Î± is 0.05 and the critical value is 1.96), ZÎ² is thecritical value of the Normal distribution at Î² (e.g. for a power of 90%, Î² is0.1 and its critical value is 1.282) and Ïƒ 1 and Ïƒ 2 are the Standarddeviations of the two groups and M1 and M2 are the means of two groups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 48

Inclusion Criteria

ASA physical status I and II 2.
Age between 18 to 60 years.
Scheduled for open nephrectomy surgery.

Exclusion Criteria

Patient refusal for procedure.
Allergic to local anaesthetics.
Infection at local site.
Bleeding disorders.
Severe kidney dysfunction.
BMI above 30kg/m2.
Inabilty to give informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the total opioid consumption over 24 hours after erector spinae block following open nephrectomy	To study the total opioid consumption over 24 hours after erector spinae block following open nephrectomy

Secondary Outcome Measures

Name	Time	Method
To study the pain intensity using Numeric Rating Scle	Pain intensity using a 10 point Numeric Rating Scale at 30 minutes, 2,4,6,8,12,18,24 hours respectively.
To study the time of first analgesic used over 24 hours	Time for first requested analgesic from time in PACU till discharge.
To study patient satisfaction using a Likert- scale questionnaire	Patient satisfaction about the overall pain management and quality of sleep at night on post operative day 0 using a Likert-scale with 0-6 score points
To study any opioid related side effects	Any side effects from opiods within the first 24 hours.

Trial Locations

Locations (1): Himlayan Institute of Medical Sciences
🇮🇳
Dehradun, UTTARANCHAL, India
Himlayan Institute of Medical Sciences
🇮🇳Dehradun, UTTARANCHAL, India
Dr Rohan Bhatia
Principal investigator
9971014232
rohanbhatia@srhu.edu.in