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

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.

Study Overview

• Status: Completed
• Conditions: Low Dose of Pethidine for Subarachnoid Anesthesia
• Intervention / Treatment: Drug: Pethidine hydrochloride; Drug: Ropivacaine HCl Inj 7.5 MG/ML; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Anticancer Hospital of Athens "Saint Savvas"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; 0.4 mgkg-1 of pethidine hydrochloride	Drug: Pethidine hydrochloride; 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
Experimental: Group II; 2ml of ropivacaine (0.75%) with 15 mcg of fentanyl	Drug: Ropivacaine HCl Inj 7.5 MG/ML; In Group II patients will be administered with 2 ml of ropivacaine (0.75%); Drug: Fentanyl; 15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saint Savvas Anticancer Hospital
• Investigators: Study Director: Sofia Poulopoulou, Head of department, Anticancer Hospital of Athens 'Saint Savvas'

Publications and helpful links

General Publications

• Luck JF, Fettes PD, Wildsmith JA. Spinal anaesthesia for elective surgery: a comparison of hyperbaric solutions of racemic bupivacaine, levobupivacaine, and ropivacaine. Br J Anaesth. 2008 Nov;101(5):705-10. doi: 10.1093/bja/aen250. Epub 2008 Sep 2.
• Mohta M. Ropivacaine: Is it a good choice for spinal anesthesia? J Anaesthesiol Clin Pharmacol. 2015 Oct-Dec;31(4):457-8. doi: 10.4103/0970-9185.169050. No abstract available.
• Lewis RP, Spiers SP, McLaren IM, Hunt PC, Smith HS. Pethidine as a spinal anaesthetic agent--a comparison with plain bupivacaine in patients undergoing transurethral resection of the prostate. Eur J Anaesthesiol. 1992 Mar;9(2):105-9.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 28, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: pethidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Ropivacaine; Meperidine
• Other Study ID Numbers: StSavvasAH 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No