A comparative evaluation of general anesthesia versus spinal anesthesia combined with paravertebral block for renal surgeries

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000837527
• Date of registration: 11/08/2015
• Prospective Registration: Yes
• Primary sponsor: Ahmed A. Eldaba
• Public title: A comparative evaluation of general anesthesia versus spinal anesthesia combined with paravertebral block for renal surgeries
• Scientific title: General anesthesia versus spinal anesthesia combined with paravertebral block for renal surgeries regarding haemodynamic parameters, surgical conditions
• Date of first enrolment: 01/09/2015
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000837527.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;

Countries of recruitment

Egypt

Contacts

• Name: A/Prof Sabry M. Amin

• Name: A/Prof Sabry M. Amin

Key inclusion & exclusion criteria

Inclusion criteria: American Society of Anesthesiologists (ASA) Class-I and II adult patients of either gender in the age group of 18-60 years undergoing renal surgeries (pyelo-lithotomy, uretero-lithotomy, and nephrectomy) will be enrolled in the study. A written informed consent will be obtained from all the patients
Exclusion criteria: diabetes mellitus, uncontrolled hypertension, cardiac rhythm disturbances, obesity, severe pulmonary disease, hepatic impairment, deranged coagulation profile, cerebrovascular disorder.


Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Anaesthetics

Renal and Urogenital - Kidney disease

Anaesthesia during renal surgeries;
Anaesthesia during renal surgeries

Intervention(s)

All patients will receive ranitidine 150 mg as premedication a night before and on the morning of surgery with a sip of water. In the operation theatre, intravenous (IV) access will be secured with 18G cannula and all patients were pre-loaded with 10 ml/kg of Ringer lactate solution. Standard monitoring include electrocardiogram, pulse oximetry (SpO 2 ), non-invasive blood pressure, urinary output and respiratory rate (RR).

Group I: includes patients for whom paravertebral catheter will be inserted on the proposed side of operation, in sitting posture, under strict aseptic precautions and after infiltration with local anesthetic, 2.5 cm lateral to the tip of spinous process of T10 vertebra, Tuohy needle was advanced perpendicular to the skin in all planes to contact the transverse process of the vertebra, typically at a depth of 2 to 4 cm. After the transverse process was identified, the needle was redirected cephalad and gradually advanced until loss of resistance was felt 1 to 1.5 cm distal to its superior edge.
Through the needle a 18G epidural catheter was placed 3 cm inside T10–T11 paravertebral space. Then, spinal anesthesia was performed with spinal needle 25 gauge at the level of L3-L4 with 2 ml bupivacine 0.5%. Sensory levels were checked with bilateral pin -prick method while motor blockade was assessed with modified Bromage scale (0 = no block, 1 = inability to raise extended leg, 2 = inability to flex the knee and 3 = inability to flex ankle and foot). Paravertebral block was performed with 10 ml bupivacine 0.5%. Equipments for general anesthesia will be ready in case of failure of regional technique.

Primary Outcome(s)

surgeon's satisfaction by 5 point scale [intra-operatively ]

Haemodynamic parameters is a composite primary outcome including; heart rate by ECG and mean arterial blood pressure by Non invasive monitor every 5 minutes for 15 minutes after induction of anesthesia and then every 15 minute till end of surgery. [Heart rate and mean arterial blood pressure every 5 minutes for 15 minutes after induction of anesthesia and then every 15 minute till end of surgery. ]

Secondary Outcome(s)

Side-effects such as nausea and vomiting, headache, respiratory depression, shivering and dry mouth will be noted during intra-operative period in awake patients[intraoperatively ]

Opioid consumption during the follow up period by patient self-report in daily diary[during follow up period (one year)]

Patient satisfaction t by 10-point scale[during surgery for awake patients, the recovery period and first analgesic requirement in the immediate post-operative period in both groups up to 12 hours post-operative]

Source(s) of Monetary Support

Ahmed A. Eldaba

Sabry M. Amin

Secondary Sponsor(s)

Sabry M. Amin

Ethics review

Status: Approved
Approval date:
Contact:

Faculty of medicine- Tanta university