PainNCT01095575
Pre- Versus Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption
A study testing normal saline 3 ml, morphine 3mg in people with Pain, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Background and Objectives: Neuraxial administration of morphine is an effective way of controlling postoperative pain and reducing analgesic consumption. Several animal models have demonstrated that preemptive administration of neuraxial narcotics reduced pain while others revealed the induction of post-incisional… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- normal saline 3 ml, morphine 3mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jan 2008
- 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 75 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.adults scheduled for elective laparotomy and colon surgery with the duration of surgery expected to last for at least 2 hours.
Who cannot join
- allergy to morphine, fentanyl, non-steroidal anti-inflammatory drugs or any of the intraoperative anesthetic medications
- use of opioids, sedatives or stimulants during 21 days prior to surgery, psychiatric illness
- congestive heart failure, respiratory failure, neuromuscular disease or presence of a chronic pain syndrome
- Pregnant women and patients unable to sign their own consent form
About this study
Official title: Pre- vs. Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption
Background and Objectives: Neuraxial administration of morphine is an effective way of controlling postoperative pain and reducing analgesic consumption. Several animal models have demonstrated that preemptive administration of neuraxial narcotics reduced pain while others revealed the induction of post-incisional hypersensitivity. There have been no consistent results in clinical setting either. This double blind, randomized study compared the effects of PRE- vs. POST-incisional administration of neuraxial morphine on postoperative pain perception and analgesic requirements over 48 hours following laparotomy for open colectomy under standardized general anesthesia.
Methods: Twenty patients received epidural morphine (3 mg) pre-incision and saline after wound closure (MO1 group), and 20 patients received epidural saline before incision and morphine after wound closure (MO2 group). Postoperatively, all patients received boluses of morphine (1.5 mg) via intravenous patient-controlled analgesia (IV-PCA), and rescue doses of intramuscular diclofenac (75 mg) every 6 hours, as needed.
- Conditions
- Pain
- Being tested
- normal saline 3 ml, morphine 3mg
- Keywords
- Epidural, Morphine, Preoperative, Postoperative, Analgesia, Tolerance, Preoperative, Postoperative Analgesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal saline 3 ml, morphine 3mgDrug
On the day of surgery, patients were brought to the operating room (OR) where routine monitors were placed and an epidural catheter was inserted at the level of L3-4 to a distance of 10 cm. All patients received two injections via the catheter: one injection contained 3 mg morphine (MO), and the other contained normal saline (NS) of the same volume. Patients were randomized to receive either NS preoperatively and MO postoperatively or vice versa. The first injection was administered 40 minutes before initiation of surgery, and the second one was given 15 minutes after surgery ended. All epidural catheters were removed before the patients were discharged from the post-anesthesia care unit (PACU).
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | NS preoperatively and MO postoperatively Receives: Drug: normal saline 3 ml, morphine 3mg |
| group 2 | Active comparator | MO preoperatively and NS postoperatively Receives: Drug: normal saline 3 ml, morphine 3mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain)
Measured: 48 hours
Secondary outcomes (1)
Consumption of analgesics
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startJan 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Avraham Weinbroum, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095575
- Sponsor's protocol ID
- weinbroum pain
- Status last verified
- Mar 2010
- First submitted
- 28 Mar 2010
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- vs. Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption
- ClinicalTrials.gov ID
- NCT01095575
- Acronym / sponsor ID
- weinbroum pain
- Conditions
- Pain
- Keywords
- Epidural, Morphine, Preoperative, Postoperative, Analgesia, Tolerance, Preoperative, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2006
- Study completion
- Jan 2008 (actual)
- First posted
- 30 Mar 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.
Background and Objectives: Neuraxial administration of morphine is an effective way of controlling postoperative pain and reducing analgesic consumption. Several animal models have demonstrated that preemptive administration of neuraxial narcotics reduced pain while others revealed the induction of post-incisional hypersensitivity. There have been no consistent results in clinical setting either. This double blind, randomized study compared the effects of PRE- vs. POST-incisional administration of neuraxial morphine on postoperative pain perception and analgesic requirements over 48 hours following laparotomy for open colectomy under standardized general anesthesia.
Methods: Twenty patients received epidural morphine (3 mg) pre-incision and saline after wound closure (MO1 group), and 20 patients received epidural saline before incision and morphine after wound closure (MO2 group). Postoperatively, all patients received boluses of morphine (1.5 mg) via intravenous patient-controlled analgesia (IV-PCA), and rescue doses of intramuscular diclofenac (75 mg) every 6 hours, as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Drug: normal saline 3 ml, morphine 3mgNS preoperatively and MO postoperatively |
| group 2 | Active comparator | Drug: normal saline 3 ml, morphine 3mgMO preoperatively and NS postoperatively |
Who may qualify
- Ages
- 18 to 75 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.adults scheduled for elective laparotomy and colon surgery with the duration of surgery expected to last for at least 2 hours.
Key exclusion criteria (4 listed)
- allergy to morphine, fentanyl, non-steroidal anti-inflammatory drugs or any of the intraoperative anesthetic medications
- use of opioids, sedatives or stimulants during 21 days prior to surgery, psychiatric illness
- congestive heart failure, respiratory failure, neuromuscular disease or presence of a chronic pain syndrome
- Pregnant women and patients unable to sign their own consent form
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 |
|---|---|---|
| normal saline 3 ml, morphine 3mgOn the day of surgery, patients were brought to the operating room (OR) where routine monitors were placed and an epidural catheter was inserted at the level of L3-4 to a distance of 10 cm. All patients received two injections via the catheter: one injection contained 3 mg morphine (MO), and the other contained normal saline (NS) of the same volume. Patients were randomized to receive either NS preoperatively and MO postoperatively or vice versa. The first injection was administered 40 minutes before initiation of surgery, and the second one was given 15 minutes after surgery ended. All epidural catheters were removed before the patients were discharged from the post-anesthesia care unit (PACU). | Drug | group 1, group 2 |
Primary outcome
Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain)
Time frame: 48 hours
1 secondary outcome
Consumption of analgesics
Time frame: 48 hours
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 12 Apr 2010.
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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.
Avraham Weinbroum, MD principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing normal saline 3 ml, morphine 3mg in people with Pain, run by Tel-Aviv Sourasky Medical Center.
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 1 inclusion and 4 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 12 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2010.