Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.

Study Overview
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Brief Summary
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The aim of this study is to assess the efficacy of subarachnoid anesthesia with low dose of pethidine (0.4mgkg-1) compared to administration of ropivacaine and fentanyl which is nowadays the common practice.

Official Title
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Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.

Conditions
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Low Dose of Pethidine for Subarachnoid Anesthesia

Intervention / Treatment
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* Drug: Pethidine hydrochloride
* Drug: Ropivacaine HCl Inj 7.5 MG/ML
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients about to be subjected to Transurethral resection of the prostate (TURP) and Transurethral resection of urinary bladder tumors (TUR) Signed informed consent Exclusion Criteria: When subarachnoid block is contraindicated Patient's denial in performing subarachnoid anesthesia Failure of subarachnoid block (L1 dermatome in 30 minutes after intrathecal drug administration) Mental illness or drug abuse Estimated time of operation >90 minutes

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized control trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>0.4 mgkg-1 of pethidine hydrochloride | Drug: Pethidine hydrochloride<br>* In Group I patients will be administered with low dose of pethidine hydrochloride (0.4 mgkg-1) diluted into normal saline up to 2 ml of total volume in order to perform subarachnoid anesthesia for urologic operations<br>|
| Experimental: Group II<br>2ml of ropivacaine (0.75%) with 15 mcg of fentanyl | Drug: Ropivacaine HCl Inj 7.5 MG/ML<br>* In Group II patients will be administered with 2 ml of ropivacaine (0.75%)<br>Drug: Fentanyl<br>* 15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test. | Low dose of pethidine hydrochloride will be administered for subarachnoid anesthesia in patients subjected to urologic operations.The level of sensory block after subarachnoid anesthesia will be assessed by the pinprick test. | 30 minutes after the intrathecal administration of the drug | 
| Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the modified Bromage scale. | The level of motor block will be assessed by the modified Bromage scale. | 30 minutes after the intrathecal administration of the drug | 
| Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the time of motor block establisment. | Time of motor block establishment (Grade 2 in modified Bromage scale) will be recorded as well as the time of withdrawal. Failure of spinal block is considered when there is no block at the level of first lumbar vertebra 30 minutes after the intrathecal administration of the drugs and in these cases the patients are excluded from the study. | 30 minutes after the intrathecal administration of the drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride. | In order to assess the efficacy of analgesia provided by the low dose of pethidine hydrochloride we record the time at which patients ask analgesic for the first time after the operation. | In the first 24 hours postoperatively | 
| Percentage of postsurgical catheter-related bladder discomfort | Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out) | Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively | 
| Assessment of haemodynamic status of patients intraoperatively | In order to assess the haemodynamic status of patients intraoperatively we record all episodes of hypotension (drop of systolic pressure >30% of value before the subarachnoid block. | During the operation | 
| Length of stay in postanesthesia care unit | We record the total amount of time that patients stay in the postanesthesia care unit immediately after the operation until they are discharged to the ward. In order for a patient to be discharged to the ward he must have a score of more than >9 in Aldrete's Scoring system. | Time of entry into postanesthesia care unit up to discharge to the ward or two hours time whichever comes first. | 
| Adverse events | We record all adverse events observed intraoperatively and 24 hours postoperatively | All adverse events observed intraoperatively and in the first 24 hours postoperatively | 
| Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride. | We also record the total amount of analgesics administered in morphine analogues in the first 24 hours postoperatively. | In the first 24 hours postoperatively | 
| Assessment of haemodynamic status of patients intraoperatively | We also record the total amount of intravenous fluids administered intraoperatively. | During the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pethidine