PainNCT01359085
Pain Relief Following Arthroscopic Rotator Cuff Repair: Perioperative Pregabalin Administration Versus Interscalene Brachial Plexus Block
A study testing Pregabalin and ISBPB - interscalene brachial plexus block in people with Pain, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Arthroscopic rotator cuff (RC) repair is often associated with severe post operative pain and discomfort. Many analgesic protocols have been proposed for pain relief following RC repair and controversy remains regarding the optimal postoperative analgesic protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Pregabalin and ISBPB - interscalene brachial plexus block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III patients (> 18 years old) with normal renal and coagulation function, scheduled for elective arthroscopic RC repair at Tel Aviv-Sourasky Medical Center or Tel Aviv Assuta Medical Center shoulder surgery unit.
Who cannot join
- Patients with known pulmonary or renal disease
- Known preexisting neurological disorders involving the operative limb
- Known hypersensitivity to the medication used in the study
- Considerable tension on the repair site requiring application of an abduction splint (on the discretion of the surgeon) and pregnant women will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky Medical Center
Tel Aviv, Weizman 6, 64239
Helena Farladansky, MD, 972-527360016, ilia2099@gmail.com
About this study
Official title: Pain Relief Following Arthroscopic Rotator Cuff Repair: Perioperative Pregabalin Administration Versus Interscalene Brachial Plexus Block. a Prospective, Randomized, Double Blinded, Multicenter Trial
Arthroscopic rotator cuff (RC) repair is often associated with severe post operative pain and discomfort. Many analgesic protocols have been proposed for pain relief following RC repair and controversy remains regarding the optimal postoperative analgesic protocol. Despite significant advancement in analgesic techniques over the last decades 50-70% of patients who undergo surgical procedures still experience moderate to severe postoperative pain. Postoperative pain has both inflammatory component (i.e. related to traumatic tissue damage and inflammatory reaction due to the surgical incision and procedure) and neuropathic component (i.e. related to over sensitization of the peripheral and central nervous system). Opioids are commonly used for postoperative pain reduction, however their use is associated with numerous adverse events and should be limited.
Regional nerve block techniques have been emerged over the past decade and have become a standard of practice recently. Recent studies indicate that a single-dose interscalene brachial plexus block (ISBPB) is effective in providing postoperative analgesia following shoulder surgery, reduces the need for opioid medication, and has a very high success rates (≥94%) and few major complications (≤0.4%). However, regional nerve blockade, including ISBPS, has a frequent incidence of temporary postoperative neurological symptoms within the first postoperative week (4 -16%), is technically demanding and might be time consuming.
Read more
Pregabalin (Lyrica) is an anticonvulsant drug with membrane stabilizing and anti-nociceptive effects commonly used for neuropathic pain relief and anxiety disorder. It desensitizes the presynaptic terminals of hyperexcited neurons in peripheral and central nervous system (i.e. reduces the transmission of excitatory neurotransmitters including glutamate, norepinephrine, substance P, and calcitonin gene-related peptide) by reducing calcium influx through high-voltage-activated calcium channels containing the alpha2/delta subunit. Pregabalin is rapidly absorbed from the gut with bioavailability of approximately 90%, achieves peak plasma concentration approximately 1h after administration, has half-life of about 6h and is eliminated by renal excretion. Many studies over the past decade have evaluated pregabalin roll in the treatment of acute postoperative pain. Pregabalin effect in reducing opioid consumption and opioid adverse events (AEs) has been well established. Its analgesic effect on acute postoperative pain remains questionable, and further studies are still required to compare pregabalin analgesic potential with other standard post-operative analgesic regimens. Pregabalin doses used in previous studies ranged from 75 to 600 mg given as a single dose 1-2h preoperatively with or without additional doses at 12h and 24h postoperatively. Doses of 150 mg and higher seemed to offer better results in terms of postoperative analgesia and opioids sparing. However higher doses were associated with higher rate of AEs, mainly sedation, dizziness and visual disturbances.
Nervous system desensitization by oral medication (e.g. pregabalin) rather than by invasive means (e.g. ISBPB) may reduce adverse reactions, increase patient satisfaction and save valuable time in the operation theater. To the investigators knowledge no previous study has compared the efficacy of pregabalin to ISBPB for acute pain relief following arthroscopic shoulder surgery. The investigators hope to contribute to the discussion regarding the optimal pain relief method following arthroscopic shoulder surgery.
- Conditions
- Pain
- Being tested
- Pregabalin, ISBPB - interscalene brachial plexus block
- Keywords
- To compare postoperative pain relief by pregabalin versus ISBPB following arthroscopic rotator cuff repair, To compare postoperative opioid consumption and opioid related AEs, To compare patients recovery profile and patients satisfaction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregabalin 75 mg will be given orally as premedication at the night before surgery (at bedtime). Pregabalin 150 mg will be administered orally at 1h preoperatively and at 12h and 24h postoperatively.
ISBPB - interscalene brachial plexus blockProcedure or surgery
ISBPB will be performed by an anesthesiology consultant experienced in performing the procedure, after the induction of GA. Block will be performed under sterile conditions by injection of 40ml 0.5% bupivacaine with epinephrine 1:100,000 to the plexus sheath through a 5-cm, 23-gauge short-beveled needle.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | Not described Receives: Drug: Pregabalin |
| ISBPB | Active comparator | Interscalene brachial plexus block Receives: Procedure: ISBPB - interscalene brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare postoperative pain relief by pregabalin versus ISBPB following arthroscopic rotator cuff repair
Clinical parameters (pain, satisfaction, recovery, opioid consumption and AE) will be assessed at arriving to the recovery unit, at 12h and 24h postoperatively and in days 2 and 7 postoperatively.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012 (estimated)
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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359085
- Sponsor's protocol ID
- TASMC-11-HF-0235-11-CTIL
- Status last verified
- Jun 2011
- First submitted
- 18 May 2011
- Last updated
- 7 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief Following Arthroscopic Rotator Cuff Repair: Perioperative Pregabalin Administration Versus Interscalene Brachial Plexus Block. a Prospective, Randomized, Double Blinded, Multicenter Trial
- ClinicalTrials.gov ID
- NCT01359085
- Acronym / sponsor ID
- TASMC-11-HF-0235-11-CTIL
- Conditions
- Pain
- Keywords
- To compare postoperative pain relief by pregabalin versus ISBPB following arthroscopic rotator cuff repair, To compare postoperative opioid consumption and opioid related AEs, To compare patients recovery profile and patients satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (estimated)
- First posted
- 24 May 2011 (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.
Arthroscopic rotator cuff (RC) repair is often associated with severe post operative pain and discomfort. Many analgesic protocols have been proposed for pain relief following RC repair and controversy remains regarding the optimal postoperative analgesic protocol. Despite significant advancement in analgesic techniques over the last decades 50-70% of patients who undergo surgical procedures still experience moderate to severe postoperative pain. Postoperative pain has both inflammatory component (i.e. related to traumatic tissue damage and inflammatory reaction due to the surgical incision and procedure) and neuropathic component (i.e. related to over sensitization of the peripheral and central nervous system). Opioids are commonly used for postoperative pain reduction, however their use is associated with numerous adverse events and should be limited.
Regional nerve block techniques have been emerged over the past decade and have become a standard of practice recently. Recent studies indicate that a single-dose interscalene brachial plexus block (ISBPB) is effective in providing postoperative analgesia following shoulder surgery, reduces the need for opioid medication, and has a very high success rates (≥94%) and few major complications (≤0.4%). However, regional nerve blockade, including ISBPS, has a frequent incidence of temporary postoperative neurological symptoms within the first postoperative week (4 -16%), is technically demanding and might be time consuming.
Pregabalin (Lyrica) is an anticonvulsant drug with membrane stabilizing and anti-nociceptive effects commonly used for neuropathic pain relief and anxiety disorder. It desensitizes the presynaptic terminals of hyperexcited neurons in peripheral and central nervous system (i.e. reduces the transmission of excitatory neurotransmitters including glutamate, norepinephrine, substance P, and calcitonin gene-related peptide) by reducing calcium influx through high-voltage-activated calcium channels containing the alpha2/delta subunit. Pregabalin is rapidly absorbed from the gut with bioavailability of approximately 90%, achieves peak plasma concentration approximately 1h after administration, has half-life of about 6h and is eliminated by renal excretion. Many studies over the past decade have evaluated pregabalin roll in the treatment of acute postoperative pain. Pregabalin effect in reducing opioid consumption and opioid adverse events (AEs) has been well established. Its analgesic effect on acute postoperative pain remains questionable, and further studies are still required to compare pregabalin analgesic potential with other standard post-operative analgesic regimens. Pregabalin doses used in previous studies ranged from 75 to 600 mg given as a single dose 1-2h preoperatively with or without additional doses at 12h and 24h postoperatively. Doses of 150 mg and higher seemed to offer better results in terms of postoperative analgesia and opioids sparing. However higher doses were associated with higher rate of AEs, mainly sedation, dizziness and visual disturbances.
Nervous system desensitization by oral medication (e.g. pregabalin) rather than by invasive means (e.g. ISBPB) may reduce adverse reactions, increase patient satisfaction and save valuable time in the operation theater. To the investigators knowledge no previous study has compared the efficacy of pregabalin to ISBPB for acute pain relief following arthroscopic shoulder surgery. The investigators hope to contribute to the discussion regarding the optimal pain relief method following arthroscopic shoulder surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Drug: Pregabalin |
| ISBPB | Active comparator | Procedure: ISBPB - interscalene brachial plexus blockInterscalene brachial plexus block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-III patients (> 18 years old) with normal renal and coagulation function, scheduled for elective arthroscopic RC repair at Tel Aviv-Sourasky Medical Center or Tel Aviv Assuta Medical Center shoulder surgery unit.
Key exclusion criteria (4 listed)
- Patients with known pulmonary or renal disease
- Known preexisting neurological disorders involving the operative limb
- Known hypersensitivity to the medication used in the study
- Considerable tension on the repair site requiring application of an abduction splint (on the discretion of the surgeon) and pregnant women will be excluded from the study.
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 |
|---|---|---|
| PregabalinPregabalin 75 mg will be given orally as premedication at the night before surgery (at bedtime). Pregabalin 150 mg will be administered orally at 1h preoperatively and at 12h and 24h postoperatively. | Drug | Pregabalin |
| ISBPB - interscalene brachial plexus blockISBPB will be performed by an anesthesiology consultant experienced in performing the procedure, after the induction of GA. Block will be performed under sterile conditions by injection of 40ml 0.5% bupivacaine with epinephrine 1:100,000 to the plexus sheath through a 5-cm, 23-gauge short-beveled needle. | Procedure or surgery | ISBPB |
Primary outcome
To compare postoperative pain relief by pregabalin versus ISBPB following arthroscopic rotator cuff repair
Time frame: 1 year
Clinical parameters (pain, satisfaction, recovery, opioid consumption and AE) will be assessed at arriving to the recovery unit, at 12h and 24h postoperatively and in days 2 and 7 postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin and ISBPB - interscalene brachial plexus block in people with Pain, run by Tel-Aviv Sourasky Medical Center at 1 site 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 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: status not confirmed, as of the sponsor's last update on 7 Jun 2011. 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 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 Helena Farladansky, MD (972-527360016, ilia2099@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare postoperative pain relief by pregabalin versus ISBPB following arthroscopic rotator cuff repair (time frame: 1 year). 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 7 Jun 2011.