Pain, PostoperativePhase 4NCT04153396
Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy
A Phase 4 study testing The Treatment group in people with Pain, Postoperative and Neurosurgery, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal space occupying lesions, spinal stenosis, disc herniation, injuries, etc. After these procedures, patients often experience severe postoperative pain at the surgical site. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pain, Postoperative, Neurosurgery
- What is being tested?
- The Treatment group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 3 Jun 2022
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for surgery under general anaesthesia for laminectomy or laminoplasty;
- American Society of Anaesthesiologists (ASA) classification of I or II;
- Age 18 to 64 years;
- Participates with an anticipated full recovery within 2 hours postoperatively.
Who cannot join
- Patient refusal;
- Participants who cannot use a patient-controlled analgesia (PCA) device and cannot understand the instructions of a Visual Analogue Score (VAS);
- Previous history of spinal surgery;
- Allergy to opioids, betamethasone or ropivacaine;
- Peri-incisional infection;
- History of stroke or a major neurological deficit;
Show all 15Show fewer
- Trauma, deformity;
- Psychological problems;
- Extreme body mass index (BMI) (< 15 or > 35);
- History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
- Patients using systemic steroids;
- Pregnant or breastfeeding;
- Preoperative Glasgow Coma Scale < 15;
- Participants who have received radiation therapy or chemotherapy preoperatively, or with a high probability to require a postoperative radiation therapy or chemotherapy according to the preoperative imaging.
- Not able to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE)
Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal space occupying lesions, spinal stenosis, disc herniation, injuries, etc. After these procedures, patients often experience severe postoperative pain at the surgical site. However, current methods of pain control are mostly insufficient. At present, several pain controlling methods are available, to reduce postoperative pain after laminoplasty or laminectomy. Methods for systemic administration include: oral analgesics, intermittent intravenous, intramuscular injections, patient- controlled intravenous analgesia, etc. However, the aforementioned methods may have a lot of side effects, and are usually used after the occurrence of pain and the analgesic effects are sometimes inadequate. Topical administration options use a lower dose of drugs and therefore have less systemic side effects. Pre-emptive injection of local anesthetics can significantly reduce postoperative pain during rest and movement, however, the analgesic effect is maintained for a relatively short period of time. It is necessary to use more cases to explore the other compatibility of drugs with longer duration of action and stronger analgesic effect. Betamethasone as the stereoisomer of dexamethasone is a long-acting corticosteroid, which has long lasting anti-inflammatory properties. Whether betamethasone combined with local anesthetic for laminoplasty or laminectomy has better short-term and long-term effects than the local anesthetic alone has not been reported yet. Therefore, a prospective, randomized, controlled, blinded-endpoint study is needed to compare the postoperative analgesic efficacy of preemptive wound infilteration of ropivacaine alone and betamethasone plus ropivacaine for laminectomy or laminoplasty.
- Conditions
- Pain, Postoperative, Neurosurgery
- Being tested
- The Treatment group, The Control group
- Keywords
- Pain, Postoperative, Betamethasone;, Ropivacaine;, Wound Infiltration, Laminoplasty or Laminectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Treatment groupDrug
The local infiltration solution in the treatment group will consist of betamethasone and ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 0.5ml of compound betamethasone injection(betamethasone propionate 5mg and betamethasone sodium phosphate 2mg per 1ml) added to 14.5ml of saline and 15ml of 1% ropivacaine. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated.
The Control groupDrug
The local infiltration solution in the control group will consist of ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 15ml of ropivacaine added to 15 ml of saline for the Control group. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated.
| Study group | Role | What they receive |
|---|---|---|
| The Treatment Group | Experimental | The local infiltration solution in the treatment group will consist of betamethasone and ropivacaine. Receives: Drug: The Treatment group |
| The Control group | Active comparator | The local infiltration solution in the control group will consist of ropivacaine. Receives: Drug: The Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative butorphanol dose during the 48 hours after surgery via the PCA device.
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.
Measured: Within 48 hours after the operation
Secondary outcomes (10)
The Visual Analogue Scale (VAS) during movement (VASm)
The pain will be assessed by the visual analogue scale (VAS) scores: an 11-point VAS score during movement (VASm) will be recorded (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)
Measured: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.
The Visual Analogue Scale (VAS) at rest (VASr)
The pain will be assessed by the visual analogue scale (VAS) scores: an 11-point VAS score at rest (VASr) will be recorded (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)
Measured: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.
The total times that participants press patient-controlled analgesia button
The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.
Measured: Within 48 hours after the operation
The first analgesia demand on the PCA device
The time from the end of the surgery to the first administration of analgesia via the PCA device
Measured: Within 48 hours postoperatively
Patient Satisfaction Score (PSS)
The Patient Satisfaction Score (PSS): 0 for unsatisfactory, and 10 for very satisfied
Measured: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 4 weeks, 6 weeks, 3 months and 6 months after surgery
The Postoperative Nausea and Vomiting (PONV)
The Postoperative Nausea and Vomiting (PONV) will be measured using an ordinal scale, with 0 indicating no nausea; 1, mild nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting.
Measured: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Ramsay Sedation Scale (RSS)
The Ramsay Sedation Scale (RSS): A 6-point scale will be used to assess sedation levels, with 1 indicating agitated, anxious; 2, cooperative; 3, only responds to commands; 4, strong response to glabellar tapping or noisy stimulants; 5, weak response to glabellar tapping or noisy stimulants; 6, no response.
Measured: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores will be used to obtain scores for four domains related to quality of life: physical health (7 items), psychological (6 items), social relationships (3items) and environment (8items). It will also include two stand-alone questions on overall quality of life and satisfaction with health. Each question will be rated on a scale of 1-5 with higher scores signifying better quality of life.
Measured: At 6 months postoperatively
The Oswestry Disability Index (ODI)
Functional disability will be assessed by the Oswestry Disability Index. It includes 10 questions about pain and activities of daily living. Each item has five response categories from no pain related disability (0), to the worst possible pain disability (100). The ODI has been reported to be the most widely used and validated outcome measure in spinal surgery.
Measured: Preoperatively and at 4 weeks, 6 weeks and 3 months, 6 months after surgery.
Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)
The Patient and Observer Scar Assessment Scale includes subjective symptoms of pain and pruritus and consists of 2 numerical scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale. It assesses vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). and it incorporates patient assessments of pain, itching, color, stiffness, thickness, relief and overall opinion. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin)
Measured: At 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Sep 2021
- Primary completion3 Dec 2021
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
- Investigators
- Fang Luo, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153396
- Sponsor's protocol ID
- KY 2019-112-02-1
- Status last verified
- Mar 2023
- First submitted
- 4 Nov 2019
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Itoh T, Tsuji H. Technical improvements and results of laminoplasty for compressive myelopathy in the cervical spine. Spine (Phila Pa 1976). 1985 Oct;10(8):729-36. doi: 10.1097/00007632-198510000-00007.
PubMed 3909451Takayasu M, Takagi T, Nishizawa T, Osuka K, Nakajima T, Yoshida J. Bilateral open-door cervical expansive laminoplasty with hydroxyapatite spacers and titanium screws. J Neurosurg. 2002 Jan;96(1 Suppl):22-8. doi: 10.3171/spi.2002.96.1.0022.
PubMed 11795710Gurbet A, Bekar A, Bilgin H, Ozdemir N, Kuytu T. Preemptive wound infiltration in lumbar laminectomy for postoperative pain: comparison of bupivacaine and levobupivacaine. Turk Neurosurg. 2014;24(1):48-53. doi: 10.5137/1019-5149.JTN.8431-13.0.
PubMed 24535791Ersayli DT, Gurbet A, Bekar A, Uckunkaya N, Bilgin H. Effects of perioperatively administered bupivacaine and bupivacaine-methylprednisolone on pain after lumbar discectomy. Spine (Phila Pa 1976). 2006 Sep 1;31(19):2221-6. doi: 10.1097/01.brs.0000232801.19965.a0.
PubMed 16946657Hetland ML, Ostergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjodt H, Ellingsen T, Lindegaard H, Podenphant J, Horslev-Petersen K; CIMESTRA study group. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP. Ann Rheum Dis. 2012 Jun;71(6):851-6. doi: 10.1136/annrheumdis-2011-200632. Epub 2012 Feb 1.
PubMed 22302316Watanabe K, Tokumine J, Yorozu T, Moriyama K, Sakamoto H, Inoue T. Particulate-steroid betamethasone added to ropivacaine in interscalene brachial plexus block for arthroscopic rotator cuff repair improves postoperative analgesia. BMC Anesthesiol. 2016 Oct 4;16(1):84. doi: 10.1186/s12871-016-0251-9.
PubMed 27716229Cherian MN, Mathews MP, Chandy MJ. Local wound infiltration with bupivacaine in lumbar laminectomy. Surg Neurol. 1997 Feb;47(2):120-2; discussion 122-3. doi: 10.1016/s0090-3019(96)00255-8.
PubMed 9040811Shrestha N, Han B, Zhao C, Jia W, Luo F. Pre-emptive infiltration with betamethasone and ropivacaine for postoperative pain in laminoplasty and laminectomy (PRE-EASE): a prospective randomized controlled trial. Int J Surg. 2024 Jan 1;110(1):183-193. doi: 10.1097/JS9.0000000000000821.
PubMed 37800559Shrestha N, Wu L, Wang X, Jia W, Luo F. Preemptive Infiltration with Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE): study protocol for a randomized controlled trial. Trials. 2020 May 5;21(1):381. doi: 10.1186/s13063-020-04308-z.
PubMed 32370780
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE)
- ClinicalTrials.gov ID
- NCT04153396
- Acronym / sponsor ID
- KY 2019-112-02-1
- Conditions
- Pain, Postoperative, Neurosurgery
- Keywords
- Pain, Postoperative, Betamethasone;, Ropivacaine;, Wound Infiltration, Laminoplasty or Laminectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 6 Nov 2019 (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.
Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal space occupying lesions, spinal stenosis, disc herniation, injuries, etc. After these procedures, patients often experience severe postoperative pain at the surgical site. However, current methods of pain control are mostly insufficient. At present, several pain controlling methods are available, to reduce postoperative pain after laminoplasty or laminectomy. Methods for systemic administration include: oral analgesics, intermittent intravenous, intramuscular injections, patient- controlled intravenous analgesia, etc. However, the aforementioned methods may have a lot of side effects, and are usually used after the occurrence of pain and the analgesic effects are sometimes inadequate. Topical administration options use a lower dose of drugs and therefore have less systemic side effects. Pre-emptive injection of local anesthetics can significantly reduce postoperative pain during rest and movement, however, the analgesic effect is maintained for a relatively short period of time. It is necessary to use more cases to explore the other compatibility of drugs with longer duration of action and stronger analgesic effect. Betamethasone as the stereoisomer of dexamethasone is a long-acting corticosteroid, which has long lasting anti-inflammatory properties. Whether betamethasone combined with local anesthetic for laminoplasty or laminectomy has better short-term and long-term effects than the local anesthetic alone has not been reported yet. Therefore, a prospective, randomized, controlled, blinded-endpoint study is needed to compare the postoperative analgesic efficacy of preemptive wound infilteration of ropivacaine alone and betamethasone plus ropivacaine for laminectomy or laminoplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Treatment Group | Experimental | Drug: The Treatment groupThe local infiltration solution in the treatment group will consist of betamethasone and ropivacaine. |
| The Control group | Active comparator | Drug: The Control groupThe local infiltration solution in the control group will consist of ropivacaine. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients scheduled for surgery under general anaesthesia for laminectomy or laminoplasty;
- American Society of Anaesthesiologists (ASA) classification of I or II;
- Age 18 to 64 years;
- Participates with an anticipated full recovery within 2 hours postoperatively.
Key exclusion criteria (15 listed)
- Patient refusal;
- Participants who cannot use a patient-controlled analgesia (PCA) device and cannot understand the instructions of a Visual Analogue Score (VAS);
- Previous history of spinal surgery;
- Allergy to opioids, betamethasone or ropivacaine;
- Peri-incisional infection;
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 |
|---|---|---|
| The Treatment groupThe local infiltration solution in the treatment group will consist of betamethasone and ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 0.5ml of compound betamethasone injection(betamethasone propionate 5mg and betamethasone sodium phosphate 2mg per 1ml) added to 14.5ml of saline and 15ml of 1% ropivacaine. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated. | Drug | The Treatment Group |
| The Control groupThe local infiltration solution in the control group will consist of ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 15ml of ropivacaine added to 15 ml of saline for the Control group. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated. | Drug | The Control group |
Primary outcome
The cumulative butorphanol dose during the 48 hours after surgery via the PCA device.
Time frame: Within 48 hours after the operation
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.
10 secondary outcomes
The Visual Analogue Scale (VAS) during movement (VASm)
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.
The Visual Analogue Scale (VAS) at rest (VASr)
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.
The total times that participants press patient-controlled analgesia button
Time frame: Within 48 hours after the operation
The first analgesia demand on the PCA device
Time frame: Within 48 hours postoperatively
Patient Satisfaction Score (PSS)
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 4 weeks, 6 weeks, 3 months and 6 months after surgery
The Postoperative Nausea and Vomiting (PONV)
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Ramsay Sedation Scale (RSS)
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores
Time frame: At 6 months postoperatively
The Oswestry Disability Index (ODI)
Time frame: Preoperatively and at 4 weeks, 6 weeks and 3 months, 6 months after surgery.
Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)
Time frame: At 6 months postoperatively
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 14 Mar 2023.
- Background: PubMed 3909451Itoh T, Tsuji H. Technical improvements and results of laminoplasty for compressive myelopathy in the cervical spine. Spine (Phila Pa 1976). 1985 Oct;10(8):729-36. doi: 10.1097/00007632-198510000-00007.
- Background: PubMed 11795710Takayasu M, Takagi T, Nishizawa T, Osuka K, Nakajima T, Yoshida J. Bilateral open-door cervical expansive laminoplasty with hydroxyapatite spacers and titanium screws. J Neurosurg. 2002 Jan;96(1 Suppl):22-8. doi: 10.3171/spi.2002.96.1.0022.
- Background: PubMed 24535791Gurbet A, Bekar A, Bilgin H, Ozdemir N, Kuytu T. Preemptive wound infiltration in lumbar laminectomy for postoperative pain: comparison of bupivacaine and levobupivacaine. Turk Neurosurg. 2014;24(1):48-53. doi: 10.5137/1019-5149.JTN.8431-13.0.
- Background: PubMed 16946657Ersayli DT, Gurbet A, Bekar A, Uckunkaya N, Bilgin H. Effects of perioperatively administered bupivacaine and bupivacaine-methylprednisolone on pain after lumbar discectomy. Spine (Phila Pa 1976). 2006 Sep 1;31(19):2221-6. doi: 10.1097/01.brs.0000232801.19965.a0.
- Background: PubMed 22302316Hetland ML, Ostergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjodt H, Ellingsen T, Lindegaard H, Podenphant J, Horslev-Petersen K; CIMESTRA study group. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP. Ann Rheum Dis. 2012 Jun;71(6):851-6. doi: 10.1136/annrheumdis-2011-200632. Epub 2012 Feb 1.
- Background: PubMed 27716229Watanabe K, Tokumine J, Yorozu T, Moriyama K, Sakamoto H, Inoue T. Particulate-steroid betamethasone added to ropivacaine in interscalene brachial plexus block for arthroscopic rotator cuff repair improves postoperative analgesia. BMC Anesthesiol. 2016 Oct 4;16(1):84. doi: 10.1186/s12871-016-0251-9.
- Background: PubMed 9040811Cherian MN, Mathews MP, Chandy MJ. Local wound infiltration with bupivacaine in lumbar laminectomy. Surg Neurol. 1997 Feb;47(2):120-2; discussion 122-3. doi: 10.1016/s0090-3019(96)00255-8.
- Derived from this study: PubMed 37800559Shrestha N, Han B, Zhao C, Jia W, Luo F. Pre-emptive infiltration with betamethasone and ropivacaine for postoperative pain in laminoplasty and laminectomy (PRE-EASE): a prospective randomized controlled trial. Int J Surg. 2024 Jan 1;110(1):183-193. doi: 10.1097/JS9.0000000000000821.
- Derived from this study: PubMed 32370780Shrestha N, Wu L, Wang X, Jia W, Luo F. Preemptive Infiltration with Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE): study protocol for a randomized controlled trial. Trials. 2020 May 5;21(1):381. doi: 10.1186/s13063-020-04308-z.
- Individual participant dataSharing planned: Yes
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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.
Fang Luo, M.D. principal investigator
Beijing Tiantan 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 The Treatment group in people with Pain, Postoperative and Neurosurgery, run by Beijing Tiantan Hospital at 1 site in China.
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 4 inclusion and 15 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 14 Mar 2023. 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 China. 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 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?
The cumulative butorphanol dose during the 48 hours after surgery via the PCA device. (time frame: Within 48 hours after the operation). 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 NCT04153396, which also lists 9 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 14 Mar 2023.