Pain, PostoperativePhase 4NCT04078139
Pre-emptive Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Postoperative Pain After Craniotomy
A Phase 4 study testing The MP/RP group and The RP group in people with Pain, Postoperative, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- The MP/RP group and The RP group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2021to 31 Dec 2021
- 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 elective craniotomy for resection of tumour under general anaesthesia;
- American Society of Anesthesiologists (ASA) physical status of I , II or III;
- Participates with an anticipated fully recovery within 2 hours postoperatively.
Who cannot join
- History of craniotomy;
- Expected delayed extubation or no plan to extubate;
- Participants who cannot use a patient-controlled analgesia (PCA) device;
- • Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
- Extreme body mass index (BMI) (< 15 or > 35);
- Allergy to opioids, methylprednisolone or ropivacaine;
Show all 14Show fewer
- 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;
- History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
- Pregnant or at breastfeeding;
- Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
- Preoperative Glasgow Coma Scale< 15;
- Suspicion of intracranial hypertension;
- Peri-incisional infection;
- Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pre-emptive Scalp Infiltration With Ropivacaine and Methylprednisolone- Ropivacaine on Pain After Craniotomy in Adults
Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. Local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as methylprednisolone as an adjuvant to local anesthetics intra-articular injected locally reduced pain intensity after total knee arthroplasty or lumbar discectomy. However, there has not been reported about local application of methylprednisolone on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.
- Conditions
- Pain, Postoperative
- Being tested
- The MP/RP group, The RP group
- Keywords
- Postoperative Pain;, Post-Craniotomy;, Methylprednisolone, Ropivacaine, Scalp Infiltration
- 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 MP/RP groupDrug
Miscible liquid of methylprednisolone and ropivacaine in this study will be peri-incisional scalp infiltration with 40mg methylprednisolone, 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
The RP groupDrug
Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
| Study group | Role | What they receive |
|---|---|---|
| The MP/RP group | Experimental | Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 40mg methylprednisolone, plus 10ml saline; Receives: Drug: The MP/RP group |
| The RP group | Active comparator | Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10ml saline; Receives: Drug: The RP group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative butorphanol consumption within 48 hours postoperatively
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 (13)
The number of participants who have no butorphanol consumption
The number of participants who have not pushed the button of patient-controlled analgesia pump.
Measured: Within 48 hours after the operation
The first time to press the patient-controlled analgesia button
The first time that the participants press the patient-controlled analgesia button.
Measured: Within 48 hours after the operation
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 postoperatively
Numerical rating scale (NRS)
Pain will be assessed after surgery by numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Measured: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery
Postoperative nausea and vomiting
Postoperative nausea and vomiting (PONV) was rated by participates as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
Measured: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Ramsay Sedation Scale (RSS)
Ramsey 1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.
Measured: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Respiratory depression
Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent.
Measured: Within 48 hours after the operation
The times of emergency reducing blood pressure after the operation
The criteria for treatment is determined by the participant's surgeon in charge.The times of emergency reducing blood pressure will be recording by the investigator.
Measured: Within 48 hours after the operation
Patient satisfactory scale (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, 1 month, 3 months and 6 months after surgery
The total consumption of opioids during the operation
The total consumption of opioids during the operation
Measured: During procedure
The length of stay
The duration of hospitalization after the operation
Measured: Approximately 2 weeks after the surgery
The World Health Organization Quality of Life (WHOQOL)-BREF
Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF is a abbreviated version of the WHOQOL-100 assessment. WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life. The mean score of items within each domain is used to calculate the domain score. A transformation method converts domain scores to a 0-100 scale.
Measured: At 1 month, 3 months and 6 months after surgery
Wound Healing Score
Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: >3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis >3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: >3-6 cm not regrowing; 4: >6 cm not regrowing; not applicable
Measured: At 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start5 Mar 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 188 participants (estimated)
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
- NCT04078139
- Sponsor's protocol ID
- KY 2018-034-02-5
- Status last verified
- Nov 2020
- First submitted
- 2 Sep 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gurbet 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 16946657Mullaji A, Kanna R, Shetty GM, Chavda V, Singh DP. Efficacy of periarticular injection of bupivacaine, fentanyl, and methylprednisolone in total knee arthroplasty:a prospective, randomized trial. J Arthroplasty. 2010 Sep;25(6):851-7. doi: 10.1016/j.arth.2009.09.007. Epub 2009 Dec 21.
PubMed 20022457Rocha-Filho PA. Post-craniotomy headache: a clinical view with a focus on the persistent form. Headache. 2015 May;55(5):733-8. doi: 10.1111/head.12563. Epub 2015 Apr 22.
PubMed 25903913Tsaousi GG, Logan SW, Bilotta F. Postoperative Pain Control Following Craniotomy: A Systematic Review of Recent Clinical Literature. Pain Pract. 2017 Sep;17(7):968-981. doi: 10.1111/papr.12548. Epub 2017 Feb 23.
PubMed 27996204Dunn LK, Naik BI, Nemergut EC, Durieux ME. Post-Craniotomy Pain Management: Beyond Opioids. Curr Neurol Neurosci Rep. 2016 Oct;16(10):93. doi: 10.1007/s11910-016-0693-y.
PubMed 27604271Rahimi SY, Alleyne CH, Vernier E, Witcher MR, Vender JR. Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis. J Neurosurg. 2010 Feb;112(2):268-72. doi: 10.3171/2008.9.17689.
PubMed 19630495
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-emptive Scalp Infiltration With Ropivacaine and Methylprednisolone- Ropivacaine on Pain After Craniotomy in Adults
- ClinicalTrials.gov ID
- NCT04078139
- Acronym / sponsor ID
- KY 2018-034-02-5
- Conditions
- Pain, Postoperative
- Keywords
- Postoperative Pain;, Post-Craniotomy;, Methylprednisolone, Ropivacaine, Scalp Infiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 5 Mar 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Sep 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.
Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. Local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as methylprednisolone as an adjuvant to local anesthetics intra-articular injected locally reduced pain intensity after total knee arthroplasty or lumbar discectomy. However, there has not been reported about local application of methylprednisolone on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The MP/RP group | Experimental | Drug: The MP/RP groupParticipates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 40mg methylprednisolone, plus 10ml saline; |
| The RP group | Active comparator | Drug: The RP groupParticipates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10ml saline; |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia;
- American Society of Anesthesiologists (ASA) physical status of I , II or III;
- Participates with an anticipated fully recovery within 2 hours postoperatively.
Key exclusion criteria (14 listed)
- History of craniotomy;
- Expected delayed extubation or no plan to extubate;
- Participants who cannot use a patient-controlled analgesia (PCA) device;
- • Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
- Extreme body mass index (BMI) (< 15 or > 35);
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 MP/RP groupMiscible liquid of methylprednisolone and ropivacaine in this study will be peri-incisional scalp infiltration with 40mg methylprednisolone, 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator. | Drug | The MP/RP group |
| The RP groupMiscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator. | Drug | The RP group |
Primary outcome
Cumulative butorphanol consumption within 48 hours postoperatively
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.
13 secondary outcomes
The number of participants who have no butorphanol consumption
Time frame: Within 48 hours after the operation
The first time to press the patient-controlled analgesia button
Time frame: Within 48 hours after the operation
The total times that participants press patient-controlled analgesia button
Time frame: Within 48 hours postoperatively
Numerical rating scale (NRS)
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery
Postoperative nausea and vomiting
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
Respiratory depression
Time frame: Within 48 hours after the operation
The times of emergency reducing blood pressure after the operation
Time frame: Within 48 hours after the operation
Patient satisfactory scale (PSS)
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery
The total consumption of opioids during the operation
Time frame: During procedure
The length of stay
Time frame: Approximately 2 weeks after the surgery
The World Health Organization Quality of Life (WHOQOL)-BREF
Time frame: At 1 month, 3 months and 6 months after surgery
Wound Healing Score
Time frame: At 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- 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 20022457Mullaji A, Kanna R, Shetty GM, Chavda V, Singh DP. Efficacy of periarticular injection of bupivacaine, fentanyl, and methylprednisolone in total knee arthroplasty:a prospective, randomized trial. J Arthroplasty. 2010 Sep;25(6):851-7. doi: 10.1016/j.arth.2009.09.007. Epub 2009 Dec 21.
- Background: PubMed 25903913Rocha-Filho PA. Post-craniotomy headache: a clinical view with a focus on the persistent form. Headache. 2015 May;55(5):733-8. doi: 10.1111/head.12563. Epub 2015 Apr 22.
- Background: PubMed 27996204Tsaousi GG, Logan SW, Bilotta F. Postoperative Pain Control Following Craniotomy: A Systematic Review of Recent Clinical Literature. Pain Pract. 2017 Sep;17(7):968-981. doi: 10.1111/papr.12548. Epub 2017 Feb 23.
- Background: PubMed 27604271Dunn LK, Naik BI, Nemergut EC, Durieux ME. Post-Craniotomy Pain Management: Beyond Opioids. Curr Neurol Neurosci Rep. 2016 Oct;16(10):93. doi: 10.1007/s11910-016-0693-y.
- Background: PubMed 19630495Rahimi SY, Alleyne CH, Vernier E, Witcher MR, Vender JR. Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis. J Neurosurg. 2010 Feb;112(2):268-72. doi: 10.3171/2008.9.17689.
- 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 MP/RP group and The RP group in people with Pain, Postoperative, 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 3 inclusion and 14 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 3 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo, M.D. (+86 13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative butorphanol consumption within 48 hours postoperatively (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 NCT04078139, which also lists 7 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 3 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.