PainNCT01246323
Combined Anesthesia for Laparoscopy Surgery in Gynecology
A study testing Spinal anesthesia with Fentanyl+ Morphine in people with Pain, run by Rambam Health Care Campus at 2 sites in Israel.
Trial summary
The purpose of this study is to determine whether combined anesthesia will provide better pain control for the postoperative period following gynecological laparoscopy surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Spinal anesthesia with Fentanyl+ Morphine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIsrael
- Study dates
- Nov 2010to Dec 2012
- Phase
- Interventional
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) physical status classification system:ASA I-III.
- Benign Gynecological Laparoscopy surgery
Who cannot join
- Patients who are not capable to sign the consent form.
- Women with known allergy to the medication used in spinal analgesia.
- Patients who are pregnant or lactating.
- Patients with contraindication to spinal analgesia.
- Patients who use opioid on a regular base.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 31096
Lior Lowenstein, MD, 97248542612 ext. 7, l_lior@rambam.health.gov.il
Dror Segal, MD, 97248542382, d_segal@rambam.health.gov.il
- Not yet recruiting
Rambam Health Care Campus
Haifa, 9602
Lior Lowenstein, MD, MS, 050-2061434, LowensteinmD@gmail.com
Lior Lowenstein, MD,MS
About this study
Official title: Combined General and Spinal Anesthesia vs. General Anesthesia for Pain Relief During Laparoscopy Gynecological Surgery
The purpose of this study is to determine whether combined anesthesia will provide better pain control for the postoperative period following gynecological laparoscopy surgery.
Read the detailed description
Following signing an informed consent patients who are scheduled for gynecological laparoscopy surgery for benign disease will randomized to general vs. combined general and spinal anesthesia.
During the postoperative period data regarding pain level as evaluated by visual analogue scale (VAS), number of doses of pain relief drugs, satisfaction and number of day in hospitalization will be collected from patient charts.
- Conditions
- Pain
- Being tested
- Spinal anesthesia with Fentanyl+ Morphine
- Keywords
- Visual analogue scale, pain level, analgesia, combined anesthesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia with Fentanyl+ MorphineProcedure or surgery
Fentanyl 15 microgram Morphine 0.1-0.5 mg
| Study group | Role | What they receive |
|---|---|---|
| combined anesthesia | Active comparator | Patients will receive spinal and general anesthesia for benign laparoscopy gynecological surgery Receives: Procedure: Spinal anesthesia with Fentanyl+ Morphine |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Pain level will be evaluated every 4 hours from the time of surgery to discharge
Measured: For the first 72 hours following surgery
Number of doses of analgesic drugs
Number of doses of analgesic medications will be collected from patients charts.
Measured: For the first 72 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Lior Lowenstein, Study chair, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246323
- Sponsor's protocol ID
- COBINED ANASTHESIA GYNECOLOGY
- Status last verified
- Nov 2010
- First submitted
- 14 Nov 2010
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones T, Tilsley DW, Wilson CB, Lammertsma AA, Brown G, Brady F, Price PM. Positron emission tomography for tumour assessment. NMR Biomed. 1992 Sep-Oct;5(5):265-9. doi: 10.1002/nbm.1940050512.
PubMed 1449966Motamed C, Bouaziz H, Franco D, Benhamou D. Analgesic effect of low-dose intrathecal morphine and bupivacaine in laparoscopic cholecystectomy. Anaesthesia. 2000 Feb;55(2):118-24. doi: 10.1046/j.1365-2044.2000.055002118.x.
PubMed 10651671Kong SK, Onsiong SM, Chiu WK, Li MK. Use of intrathecal morphine for postoperative pain relief after elective laparoscopic colorectal surgery. Anaesthesia. 2002 Dec;57(12):1168-73. doi: 10.1046/j.1365-2044.2002.02873.x.
PubMed 12437707Karaman S, Kocabas S, Uyar M, Zincircioglu C, Firat V. Intrathecal morphine: effects on perioperative hemodynamics, postoperative analgesia, and stress response for total abdominal hysterectomy. Adv Ther. 2006 Mar-Apr;23(2):295-306. doi: 10.1007/BF02850135.
PubMed 16751162
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined General and Spinal Anesthesia vs. General Anesthesia for Pain Relief During Laparoscopy Gynecological Surgery
- ClinicalTrials.gov ID
- NCT01246323
- Acronym / sponsor ID
- COBINED ANASTHESIA GYNECOLOGY
- Conditions
- Pain
- Keywords
- Visual analogue scale, pain level, analgesia, combined anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 23 Nov 2010 (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.
The purpose of this study is to determine whether combined anesthesia will provide better pain control for the postoperative period following gynecological laparoscopy surgery.
Detailed description
Following signing an informed consent patients who are scheduled for gynecological laparoscopy surgery for benign disease will randomized to general vs. combined general and spinal anesthesia.
During the postoperative period data regarding pain level as evaluated by visual analogue scale (VAS), number of doses of pain relief drugs, satisfaction and number of day in hospitalization will be collected from patient charts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined anesthesia | Active comparator | Procedure: Spinal anesthesia with Fentanyl+ MorphinePatients will receive spinal and general anesthesia for benign laparoscopy gynecological surgery |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) physical status classification system:ASA I-III.
- Benign Gynecological Laparoscopy surgery
Key exclusion criteria (5 listed)
- Patients who are not capable to sign the consent form.
- Women with known allergy to the medication used in spinal analgesia.
- Patients who are pregnant or lactating.
- Patients with contraindication to spinal analgesia.
- Patients who use opioid on a regular base.
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 |
|---|---|---|
| Spinal anesthesia with Fentanyl+ MorphineFentanyl 15 microgram Morphine 0.1-0.5 mg | Procedure or surgery | combined anesthesia |
Primary outcome
Pain level
Time frame: For the first 72 hours following surgery
Pain level will be evaluated every 4 hours from the time of surgery to discharge
Number of doses of analgesic drugs
Time frame: For the first 72 hours following surgery
Number of doses of analgesic medications will be collected from patients charts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
- Background: PubMed 1449966Jones T, Tilsley DW, Wilson CB, Lammertsma AA, Brown G, Brady F, Price PM. Positron emission tomography for tumour assessment. NMR Biomed. 1992 Sep-Oct;5(5):265-9. doi: 10.1002/nbm.1940050512.
- Background: PubMed 10651671Motamed C, Bouaziz H, Franco D, Benhamou D. Analgesic effect of low-dose intrathecal morphine and bupivacaine in laparoscopic cholecystectomy. Anaesthesia. 2000 Feb;55(2):118-24. doi: 10.1046/j.1365-2044.2000.055002118.x.
- Background: PubMed 12437707Kong SK, Onsiong SM, Chiu WK, Li MK. Use of intrathecal morphine for postoperative pain relief after elective laparoscopic colorectal surgery. Anaesthesia. 2002 Dec;57(12):1168-73. doi: 10.1046/j.1365-2044.2002.02873.x.
- Background: PubMed 16751162Karaman S, Kocabas S, Uyar M, Zincircioglu C, Firat V. Intrathecal morphine: effects on perioperative hemodynamics, postoperative analgesia, and stress response for total abdominal hysterectomy. Adv Ther. 2006 Mar-Apr;23(2):295-306. doi: 10.1007/BF02850135.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Lior Lowenstein study chair
Rambam Health Care Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia with Fentanyl+ Morphine in people with Pain, run by Rambam Health Care Campus at 2 sites in Israel.
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: status not confirmed, as of the sponsor's last update on 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lior Lowenstein, MD, MS (050-2061434, LowensteinMD@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: For the first 72 hours following surgery). The study lists 2 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 NCT01246323, which also lists 4 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 5 Aug 2011.