Low Dose of Pethidine for Subarachnoid AnesthesiaPhase 2/3NCT03260283

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

A Phase 2/3 study testing Pethidine hydrochloride, Ropivacaine HCl Inj 7.5 MG/ML and Fentanyl in people with Low Dose of Pethidine for Subarachnoid Anesthesia, run by Saint Savvas Anticancer Hospital at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Low Dose of Pethidine for Subarachnoid Anesthesia
What is being tested?: Pethidine hydrochloride, Ropivacaine HCl Inj 7.5 MG/ML and Fentanyl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteGreece
Study dates: 16 Aug 2017to 31 Dec 2019
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients about to be subjected to Transurethral resection of the prostate (TURP) and Transurethral resection of urinary bladder tumors (TUR)
Signed informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

Anticancer Hospital of Athens "Saint Savvas"
Athens

Other trials in Greece

About this study

Conditions: Low Dose of Pethidine for Subarachnoid Anesthesia
Being tested: Pethidine hydrochloride, Ropivacaine HCl Inj 7.5 MG/ML, Fentanyl
Keywords: pethidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pethidine hydrochlorideDrug
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
Ropivacaine HCl Inj 7.5 MG/MLDrug
In Group II patients will be administered with 2 ml of ropivacaine (0.75%)
FentanylDrug
15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations

Study groups in NCT03260283
Study group	Role	What they receive
Group I	Experimental	0.4 mgkg-1 of pethidine hydrochloride Receives: Drug: Pethidine hydrochloride
Group II	Experimental	2ml of ropivacaine (0.75%) with 15 mcg of fentanyl Receives: Drug: Ropivacaine HCl Inj 7.5 MG/ML; Drug: Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 30 minutes after the intrathecal administration of the drug

Secondary outcomes (7)

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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: In the first 24 hours postoperatively
Assessment of haemodynamic status of patients intraoperatively
We also record the total amount of intravenous fluids administered intraoperatively.
Measured: During the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 201731 Dec 2019

First posted24 Aug 2017
Study start16 Aug 2017
Primary completion29 Nov 2018
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Low Dose of Pethidine for Subarachnoid AnesthesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double blind randomized control trial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03260283
Sponsor's protocol ID: StSavvasAH 2
Status last verified: Mar 2020
First submitted: 8 Aug 2017
Last updated: 31 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 18765643
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.
PubMed 26702199
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.
PubMed 1555549

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.
ClinicalTrials.gov ID: NCT03260283
Acronym / sponsor ID: StSavvasAH 2
Conditions: Low Dose of Pethidine for Subarachnoid Anesthesia
Keywords: pethidine
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Saint Savvas Anticancer HospitalUniversity, hospital or other
Study start: 16 Aug 2017 (actual)
Primary completion: 29 Nov 2018 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 24 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Double blind randomized control trial

Arm	Type	Receives
Group I	Experimental	Drug: Pethidine hydrochloride0.4 mgkg-1 of pethidine hydrochloride
Group II	Experimental	Drug: Ropivacaine HCl Inj 7.5 MG/ML, Drug: Fentanyl2ml of ropivacaine (0.75%) with 15 mcg of fentanyl

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

All patients about to be subjected to Transurethral resection of the prostate (TURP) and Transurethral resection of urinary bladder tumors (TUR)
Signed informed consent

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pethidine hydrochlorideIn 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	Drug	Group I
Ropivacaine HCl Inj 7.5 MG/MLIn Group II patients will be administered with 2 ml of ropivacaine (0.75%)	Drug	Group II
Fentanyl15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations	Drug	Group II

Primary outcome

Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test.
Time frame: 30 minutes after the intrathecal administration of the drug
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.
Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the modified Bromage scale.
Time frame: 30 minutes after the intrathecal administration of the drug
The level of motor block will be assessed by the modified Bromage scale.
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 frame: 30 minutes after the intrathecal administration of the drug
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.

7 secondary outcomes

Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.
Time frame: In the first 24 hours postoperatively
Percentage of postsurgical catheter-related bladder discomfort
Time frame: Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively
Assessment of haemodynamic status of patients intraoperatively
Time frame: During the operation
Length of stay in postanesthesia care unit
Time frame: Time of entry into postanesthesia care unit up to discharge to the ward or two hours time whichever comes first.
Adverse events
Time frame: 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.
Time frame: In the first 24 hours postoperatively
Assessment of haemodynamic status of patients intraoperatively
Time frame: During the operation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
Background: PubMed 18765643Luck 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.
Background: PubMed 26702199Mohta 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.
Background: PubMed 1555549Lewis 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.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sofia Poulopoulou, Head of department study director

Anticancer Hospital of Athens 'Saint Savvas'

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test. (time frame: 30 minutes after the intrathecal administration of the drug). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03260283, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.