Pain, PostoperativePhase 4NCT01526525

Perioperative Electroacupuncture on Postoperative Analgesia in Prostatectomy

A Phase 4 study testing Tramadol, Ketamine and Morphine in people with Pain, Postoperative, run by G.Gennimatas General 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 the present study is the comparison of the efficacy of the perioperative application of a multimodal analgesia model to the patients, combing common used analgesics via intravenous (IV) route, such as tramadol and ketamine, with or without the Electroacupuncture (E/A) technique application and the frequency… Read more about this study

Who is it for?: Ages 50 to 75 years, men only
Conditions the study is for: Pain, Postoperative
What is being tested?: Tramadol, Ketamine and Morphine
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteGreece
Study dates: Jul 2009to Feb 2012
Phase: Phase 4
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 50 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male patient is over 18 years old, especially 50-75 years old
Patient scheduled for a non-emergency operation
Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Who cannot join

Patient receiving monoamine oxidase inhibitors and selective serotonin reuptake inhibitors
Patient with significant cardiovascular, pulmonary, renal or hepatic disease
Patient with epilepsy non controlled with treatment or history of seizures
Patient with morbid obesity (BMI>35)
Patient with history of chronic opioid exposure
Patient with history of chronic pain

Show all 12Show fewer

Patient with history of postoperative nausea and vomiting
Patient with cognitive dysfunction
Patient with history of previous usage of the acupuncture technique
Patient Greek speaking
Patient is participating in another clinical trial which may affect this study's outcomes
Patient with metastatic cancer

Trial locations and contacts

1 site in 1 country.

Greece1 site

G.Gennimatas GENERAL HOSPITAL OF THESSALONIKI
Thessaloniki, 54635

Other trials in Greece

About this study

Official title: Effect of Perioperative Electroacupuncture With Tramadol and Ketamine on Postoperative Analgesia in Prostatectomy: a Randomized Placebo-controlled Trial

Read the detailed description

Seventy patients were scheduled for radical prostatectomy, were recruited to this prospective single-blind, were randomized and placebo-controlled by trial. They were randomly divided into two groups of 35 patients each by a computer-generated randomization sequence, the TKE (Tramadol + Ketamine + Electroacupuncture), and TK (Tramadol + Ketamine + placebo Electroacupuncture.The randomization performed by the certified acupuncturist.

Patients were anesthetized with the same protocol by five anesthesiologists, who were not involved in the postoperative assessment of the patients, but were aware in which group acupuncture was used and in which not. Both groups, TKE and TK, were administered tramadol 1.5mg/kg and ketamine 10mg bolus IV 30min before the end of the surgery and co instantaneously the CIV infusion of tramadol 0.15mg/kg/h and ketamine, in subanesthetic doses, 0.15mg/kg/h started with continuous infusion in an adjustable flow disposable pump (paragon®).Ketamine's dose was altered so as not to exceed the 300mg/24h. An hour before the end of the surgery all patients were administered with parecoxib 40mg (IV) and 30min before paracetamol 20mg/kg (IV).

In TKE group when the closure of the abdominal walls started, a certified acupuncturist expert put needles, Ener-Qi 0.26Χ25mms, in LI4 point at 2cm depth in both hands and E/A was applied for 30min with the E/A stimulator ITO ES-160 in constant pulse program with 300μs duration and 100Hz frequency. After the needles were connected to the E/A stimulator, they were secured by adhesive tape. The response which certified the right needle placement was the adjacent muscular twitch. Thereafter the electroacupuncture machine was deactivated and after the awakening of the patients, E/A was administered in ST36 and LI4 points for 30min with 4Hz frequency. The electrodes were connected to each other in every point, as the right with the left point of LI4 and the right with the left point of ST36. In the TK group the needles were not inserted in the skin but they were put atop the skin and were secured by adhesive tape, the indicator light was on but no electrical current was applied. The patients were told that they may or may not feel electrical current because of its very high frequency.

The study was single blind as patients although they were informed for the Electroacupuncture (E/A) technique during the first session they were anesthetized and the second one was after the awakening of anesthesia and they didn't understand it. On the other hand anaesthesiologists and the certified acupuncturist during the EAc application knew in which group patients belong although they did not deal with them postoperatively. However, patient assessments were performed at standard time points as 45 min in recovery and at 2 h, 6 h, 12 h and 24 h after surgery in the ward by another anaesthesiologist who was not present during the surgery or the recovery room for the first 30 min.

Conditions: Pain, Postoperative
Being tested: Tramadol, Ketamine, Morphine, sedation, rescue analgesia
Keywords: tramadol, ketamine, parecoxib, paracetamol, numerical rating scale (NRS), McGill (SF-MPQ), electronic pressure algometer, Spielberger State Trait Anxiety Inventory STAI Y-6 item
Medical subject headings: Pain, Postoperative

What participants receive

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

TramadolDrug
Tramadol 1.5mg/kg bolus IV 30min before the end of the surgery and co instantaneously the CIV infusion of tramadol 0.15mg/kg/h started with continuous infusion in an adjustable flow disposable pump (paragon®)
KetamineDrug
ketamine 10mg bolus IV 30min before the end of the surgery and co instantaneously the CIV infusion of ketamine, in subanesthetic doses, 0,15mg/kg/h started with continuous infusion in an adjustable flow disposable pump (paragon®). Ketamine's dose was altered so as not to exceed the 300mg/24h.
TramadolDrug
If NRS scale was ≥3, PPI scale ≥2 and the algometer count ≤0,5Kg it was assumed as a non acceptable pain treatment. Tramadol 50mg IV bolus was firstly administered to the patients.The aim was that the Tramadol 24h dose would not exceed 600mg
MorphineDrug
If NRS scale was ≥3, PPI scale ≥2 and the algometer count ≤0,5Kg it was assumed as a non acceptable pain treatment. Tramadol 50mg IV bolus was firstly administered to the patients and if the NRS scale was not decreased at least about 2 points after 30 minutes, morphine 2mg IV was then administered and it could be repeated
sedationProcedure or surgery
If the patient had sedation score >2 then the analgesic infusion would be stopped, the patient would be assessed again in 1 hour and the infusion would start with the same or decreased flow.
rescue analgesiaProcedure or surgery
Meanwhile - 45min,2h,6h,12h and 24h- if the patients had acute pain, the physician would call the anesthesiologist and a new assessment would take place with the relative interventions.
ParecoxibDrug
An hour before the end of the surgery all patients were administered with parecoxib 40mg (IV)
paracetamolDrug
30min before the end of the surgery paracetamol 20mg/kg (IV).

Study groups in NCT01526525
Study group	Role	What they receive
TK	Placebo comparator	In TK group when the closure of the abdominal walls started, a certified acupuncturist expert put needles, Ener-Qi 0.26Χ25mms, in LI4 point in both hands, the needles were not inserted in the skin but they were put atop the skin and were secured by adhesive tape. For 30min in the E/A stimulator ITO ES-160 the indicator light was on but no electrical current was applied. Thereafter the E/A device deactivated and after the awakening of the patients, it was connected in ST36 and LI4 points for 30min with the same technique. The electrodes were connected to each other in every point, as the right with the left point of LI4 and the right with the left point of ST36. The patients were told that they may or may not feel electrical current because of its very high frequency. Receives: Drug: Tramadol; Drug: Ketamine; Drug: Morphine; Procedure: sedation; Procedure: rescue analgesia; Drug: Parecoxib; Drug: paracetamol
TKE	Active comparator	In TKE group when the closure of the abdominal walls started, a certified acupuncturist expert put needles, Ener-Qi 0.26Χ25mms, in LI4 point at 2cm depth in both hands and E/A was applied for 30min with the E/A stimulator ITO ES-160 in constant pulse program with 300μs duration and 100Hz frequency. After the needles were connected to the E/A stimulator, they were secured by adhesive tape. The response which certified the right needle placement was the adjacent muscular twitch. Thereafter the E/A device was deactivated and after the awakening of the patients, E/A was administered in ST36 and LI4 points for 30min with 4Hz frequency. The electrodes were connected to each other in every point, as the right with the left point of LI4 and the right with the left point of ST36. Receives: Drug: Tramadol; Drug: Ketamine; Drug: Morphine; Procedure: sedation; Procedure: rescue analgesia; Drug: Parecoxib; Drug: paracetamol

What is being measured

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

PAIN SCALES
Numerical Rating Scale (NRS) 0-10,from 0=no pain to 10=worst pain imaginable. Present Pain Intensity (PPI) 0-5,from 0= no pain to 5= excruciating. McGill pain scale (SF-MPQ) 0-3,from 0=no pain to 3=severe pain
Measured: 45min, 2h, 6h, 12h and 24h following the surgery
PATIENTS PAIN THRESHOLD WITH ELECTRONIC PRESSURE ALGOMETER
The electronic pressure algometer device was applied 2cm bilateral the middle of the midline extraperitoneal lower abdominal incision and were recorded the pain threshold. It converted in Kg
Measured: 45min, 2h, 6h, 12h and 24h following the surgery
NUMBER OF PARTICIPANTS WITH ADVERSE EVENTS
Nausea:yes/no vomiting:yes/no pruritus:yes/no bowel movement:yes/no Sedation scale 0-3, from 0= awake or sleepy that answers to the questions to 3=asleep who doesn't awake not even with a prod
Measured: 45min, 2h, 6h, 12h and 24h following the surgery
PATIENTS RESCUE ANALGESIA
If NRS scale was ≥3, PPI scale ≥2 and the algometer count ≤0,5Kg it was assumed as a non acceptable pain treatment. Tramadol 50mg IV bolus was firstly administered to the patients and if the NRS scale was not decreased at least about 2 points after 30 minutes, morphine 2mg IV was then administered and it could be repeated. The aim was that the Tramadol 24h dose would not exceed 600mg. So with rescue analgesia, tramadol or morphine in mg, we count the total amount of opioids administered
Measured: 45min, 2h, 6h,12h and 24h following the surgery
CORTIZOL
Cortizol levels: ug/dl
Measured: : 1st at 8am at the day of the surgery (Cort1), 2nd 45min after the end of the surgery (Cort2) and 3rd at 8am the first postoperative day (Cort3)

Secondary outcomes (3)

PATIENTS WELLBEING,
Spielberger State Trait Anxiety Inventory (STAI Y-6 item) 1-4, where 1=not at all and 4 =very much so.
Measured: Preoperatively and 24h following the surgery
SATISFACTION
Verbal Rating Scale (VRS) with 6 levels of satisfaction 1-6,from 1=very dissatisfied to 6= very satisfied
Measured: 24h following the surgery
SLEEP DISORDERS
Answer to questions such as "if they slept well?" yes/no "they had nightmares or bad dreams?" yes/no
Measured: 24h following the surgery

Timeline

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

Jul 2009Feb 2012

First posted6 Feb 2012 (estimated)
Study startJul 2009
Primary completionSep 2011
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01526525
Sponsor's protocol ID: 6151/ 22-7-2009
Status last verified: Feb 2014
First submitted: 28 Jan 2012
Last updated: 21 Feb 2014
Results posted: No
Data monitoring committee: No

Publications

Ntritsou V, Mavrommatis C, Kostoglou C, Dimitriadis G, Tziris N, Zagka P, Vasilakos D. Effect of perioperative electroacupuncture as an adjunctive therapy on postoperative analgesia with tramadol and ketamine in prostatectomy: a randomised sham-controlled single-blind trial. Acupunct Med. 2014 Jun;32(3):215-22. doi: 10.1136/acupmed-2013-010498. Epub 2014 Jan 30.
PubMed 24480836

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Perioperative Electroacupuncture With Tramadol and Ketamine on Postoperative Analgesia in Prostatectomy: a Randomized Placebo-controlled Trial
ClinicalTrials.gov ID: NCT01526525
Acronym / sponsor ID: 6151/ 22-7-2009
Conditions: Pain, Postoperative
Keywords: tramadol, ketamine, parecoxib, paracetamol, numerical rating scale (NRS), McGill (SF-MPQ), electronic pressure algometer, Spielberger State Trait Anxiety Inventory STAI Y-6 item
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: G.Gennimatas General HospitalUniversity, hospital or other
Collaborators: Aristotle University Of Thessaloniki
Study start: Jul 2009
Primary completion: Sep 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 6 Feb 2012 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
TK	Placebo comparator	Drug: Tramadol, Drug: Ketamine, Drug: Morphine, Procedure: sedation, Procedure: rescue analgesia, Drug: Parecoxib, Drug: paracetamolIn TK group when the closure of the abdominal walls started, a certified acupuncturist expert put needles, Ener-Qi 0.26Χ25mms, in LI4 point in both hands, the needles were not inserted in the skin but they were put atop the skin and were secured by adhesive tape. For 30min in the E/A stimulator ITO ES-160 the indicator light was on but no electrical current was applied. Thereafter the E/A device deactivated and after the awakening of the patients, it was connected in ST36 and LI4 points for 30min with the same technique. The electrodes were connected to each other in every point, as the right with the left point of LI4 and the right with the left point of ST36. The patients were told that they may or may not feel electrical current because of its very high frequency.
TKE	Active comparator	Drug: Tramadol, Drug: Ketamine, Drug: Morphine, Procedure: sedation, Procedure: rescue analgesia, Drug: Parecoxib, Drug: paracetamolIn TKE group when the closure of the abdominal walls started, a certified acupuncturist expert put needles, Ener-Qi 0.26Χ25mms, in LI4 point at 2cm depth in both hands and E/A was applied for 30min with the E/A stimulator ITO ES-160 in constant pulse program with 300μs duration and 100Hz frequency. After the needles were connected to the E/A stimulator, they were secured by adhesive tape. The response which certified the right needle placement was the adjacent muscular twitch. Thereafter the E/A device was deactivated and after the awakening of the patients, E/A was administered in ST36 and LI4 points for 30min with 4Hz frequency. The electrodes were connected to each other in every point, as the right with the left point of LI4 and the right with the left point of ST36.

Who may qualify

Ages: 50 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male patient is over 18 years old, especially 50-75 years old
Patient scheduled for a non-emergency operation
Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Key exclusion criteria (12 listed)

Patient receiving monoamine oxidase inhibitors and selective serotonin reuptake inhibitors
Patient with significant cardiovascular, pulmonary, renal or hepatic disease
Patient with epilepsy non controlled with treatment or history of seizures
Patient with morbid obesity (BMI>35)
Patient with history of chronic opioid exposure

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
TramadolTramadol 1.5mg/kg bolus IV 30min before the end of the surgery and co instantaneously the CIV infusion of tramadol 0.15mg/kg/h started with continuous infusion in an adjustable flow disposable pump (paragon®)	Drug	TK, TKE
Ketamineketamine 10mg bolus IV 30min before the end of the surgery and co instantaneously the CIV infusion of ketamine, in subanesthetic doses, 0,15mg/kg/h started with continuous infusion in an adjustable flow disposable pump (paragon®). Ketamine's dose was altered so as not to exceed the 300mg/24h.	Drug	TK, TKE
TramadolIf NRS scale was ≥3, PPI scale ≥2 and the algometer count ≤0,5Kg it was assumed as a non acceptable pain treatment. Tramadol 50mg IV bolus was firstly administered to the patients.The aim was that the Tramadol 24h dose would not exceed 600mg	Drug	TK, TKE
MorphineIf NRS scale was ≥3, PPI scale ≥2 and the algometer count ≤0,5Kg it was assumed as a non acceptable pain treatment. Tramadol 50mg IV bolus was firstly administered to the patients and if the NRS scale was not decreased at least about 2 points after 30 minutes, morphine 2mg IV was then administered and it could be repeated	Drug	TK, TKE
sedationIf the patient had sedation score >2 then the analgesic infusion would be stopped, the patient would be assessed again in 1 hour and the infusion would start with the same or decreased flow.	Procedure or surgery	TK, TKE
rescue analgesiaMeanwhile - 45min,2h,6h,12h and 24h- if the patients had acute pain, the physician would call the anesthesiologist and a new assessment would take place with the relative interventions.	Procedure or surgery	TK, TKE
ParecoxibAn hour before the end of the surgery all patients were administered with parecoxib 40mg (IV)	Drug	TK, TKE
paracetamol30min before the end of the surgery paracetamol 20mg/kg (IV).	Drug	TK, TKE

Primary outcome

PAIN SCALES
Time frame: 45min, 2h, 6h, 12h and 24h following the surgery
Numerical Rating Scale (NRS) 0-10,from 0=no pain to 10=worst pain imaginable. Present Pain Intensity (PPI) 0-5,from 0= no pain to 5= excruciating. McGill pain scale (SF-MPQ) 0-3,from 0=no pain to 3=severe pain
PATIENTS PAIN THRESHOLD WITH ELECTRONIC PRESSURE ALGOMETER
Time frame: 45min, 2h, 6h, 12h and 24h following the surgery
The electronic pressure algometer device was applied 2cm bilateral the middle of the midline extraperitoneal lower abdominal incision and were recorded the pain threshold. It converted in Kg
NUMBER OF PARTICIPANTS WITH ADVERSE EVENTS
Time frame: 45min, 2h, 6h, 12h and 24h following the surgery
Nausea:yes/no vomiting:yes/no pruritus:yes/no bowel movement:yes/no Sedation scale 0-3, from 0= awake or sleepy that answers to the questions to 3=asleep who doesn't awake not even with a prod
PATIENTS RESCUE ANALGESIA
Time frame: 45min, 2h, 6h,12h and 24h following the surgery
If NRS scale was ≥3, PPI scale ≥2 and the algometer count ≤0,5Kg it was assumed as a non acceptable pain treatment. Tramadol 50mg IV bolus was firstly administered to the patients and if the NRS scale was not decreased at least about 2 points after 30 minutes, morphine 2mg IV was then administered and it could be repeated. The aim was that the Tramadol 24h dose would not exceed 600mg. So with rescue analgesia, tramadol or morphine in mg, we count the total amount of opioids administered
CORTIZOL
Time frame: : 1st at 8am at the day of the surgery (Cort1), 2nd 45min after the end of the surgery (Cort2) and 3rd at 8am the first postoperative day (Cort3)
Cortizol levels: ug/dl

3 secondary outcomes

PATIENTS WELLBEING,
Time frame: Preoperatively and 24h following the surgery
SATISFACTION
Time frame: 24h following the surgery
SLEEP DISORDERS
Time frame: 24h following the surgery

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 21 Feb 2014.
Derived from this study: PubMed 24480836Ntritsou V, Mavrommatis C, Kostoglou C, Dimitriadis G, Tziris N, Zagka P, Vasilakos D. Effect of perioperative electroacupuncture as an adjunctive therapy on postoperative analgesia with tramadol and ketamine in prostatectomy: a randomised sham-controlled single-blind trial. Acupunct Med. 2014 Jun;32(3):215-22. doi: 10.1136/acupmed-2013-010498. Epub 2014 Jan 30.

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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.

VAGIA NTRITSOU principal investigator

G.Gennimatas General Hospital

DIMITRIOS VASILAKOS study director

Aristotle University Of Thessaloniki

GEORGIOS DIMITRIADIS study director

G.Gennimatas General Hospital

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tramadol, Ketamine and Morphine in people with Pain, Postoperative, run by G.Gennimatas General Hospital at 1 site in Greece.

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 3 inclusion and 12 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 21 Feb 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

PAIN SCALES (time frame: 45min, 2h, 6h, 12h and 24h following the surgery). The study lists 5 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 NCT01526525, which also lists 1 linked publication.

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 21 Feb 2014.