PainPhase 4NCT04141319
Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Post-craniotomy Pain
A Phase 4 study testing Ketorolac, Ropivacaine and Epinephrine in people with Pain and Supratentorial Brain Tumor, run by Beijing Tiantan Hospital.
Trial summary
The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical study to compare the efficacy and safety of pre-emptive scalp infiltration with ropivacaine plus ketorolac and ropivacaine alone for postoperative pain relief in adults undergoing elective… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Supratentorial Brain Tumor
- What is being tested?
- Ketorolac, Ropivacaine and Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective supratentorial tumour resection;
- Planned general anaesthesia;
- American Society of Anesthesiologists (ASA) physical status I - II;
- Age ranging from 18 to 65 years old;
- Participates required to fix their head in a head clamp intraoperatively;
- Participates with an anticipated awake within 2 hours after surgery.
Who cannot join
- Allergy/intolerance to study drugs including anesthetic drugs, ketorolac and epinephrine;
- Expected delayed extubation or no plan to extubate;
- History of neurosurgeries;
- Long-term use of analgesics and sedatives (more than 2 weeks)
- Receiving any painkiller within 24 h before the operation;
- Extreme body mass index (BMI) (less than 15 or more than 35);
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- Patients with impaired cardiopulmonary;
- Patients with impaired renal function;
- Patients with impaired hepatic function;
- History of chronic headache;
- Patients with cognitive deficit;
- Patients with intellectual disability;
- Patients with uncontrolled epilepsy;
- Patients with psychiatric disorders;
- Difficulties in using PCA device
- Difficulties in understanding the use of numeral rating scale (NRS) ;
- Patients with suspected intracranial hypertension;
- Pregnant or at breastfeeding;
- Infection at the incisional site；
- History of radiation therapy and chemotherapy preoperatively
- With great likelihood of postoperative radiation therapy and chemotherapy based on preoperative imaging.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS)
The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical study to compare the efficacy and safety of pre-emptive scalp infiltration with ropivacaine plus ketorolac and ropivacaine alone for postoperative pain relief in adults undergoing elective supratentorial craniotomies.
Read the detailed description
The proposed study will be a single-center, prospective, randomized, open-label, blinded-endpoint clinical trial designed to test the hypothesis that the addition of ketorolac to pre-emptive scalp infiltration analgesia can significantly improve analgesia after craniotomies. One hundred participants will be randomized to the ketorolac group or the control group. Patients in the ketorolac group will receive pre-emptive scalp infiltration with opivacaine,ketorolac and epinephrine while patients in the control group will receive pre-emptive scalp infiltration with ropivacaine and epinephrine.The primary outcome measure will be cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively.
- Conditions
- Pain, Supratentorial Brain Tumor
- Being tested
- Ketorolac, Ropivacaine, Epinephrine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
30ml of local infiltration solution containing 60mg ropivacaine
RopivacaineDrug
30ml of local infiltration solution containing 6mg ketorolac
EpinephrineDrug
30ml of local infiltration solution containing 0.1mg epinephrine
| Study group | Role | What they receive |
|---|---|---|
| The ketorolac group | Experimental | Patients assigned to the ketorolac group will receive pre-emptive scalp infiltration with 30ml of local infiltration solution containing 60 mg ropivacaine, 6 mg ketorolac and 0.1mg epinephrine. Receives: Drug: Ketorolac; Drug: Ropivacaine; Drug: Epinephrine |
| The control group | Active comparator | In the control group, preoperative peri-incisional scalp infiltration will be performed using 30ml of 60 mg ropivacaine and 0.1mg epinephrine. Receives: Drug: Ropivacaine; Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively
The primary outcome measure will be cumulative doses of PCA butorphanol consumption from 0 to 48 h postoperatively
Measured: 0 to 48 hours postoperatively
Secondary outcomes (14)
The time to first request for patient-controlled analgesia butorphanol
The time to first request for patient-controlled analgesia butorphanol
Measured: Within 48hours postoperatively
frequency of pressing patient-controlled analgesia pump
frequency of patient-controlled analgesia pump
Measured: Within 48hours postoperatively
numeral rating scale (NRS) Score
0 for"no pain" and 10 for "'pain as severe as you can imagine"
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 postoperatively
Pain control satisfaction score (PCSS) postoperatively
0 for unsatisfactory and 10 for very satisfactory
Measured: at 24 hours, 48 hours, 72 hours, 1 week, 1 month, 3 months and 6 months
Ramsay sedation score (RSS)
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.
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 and 48 hours and 72 hours postoperatively
pulse oxygen saturation(SpO2)
SpO2
Measured: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
mean arterial blood pressure(MAP)
MAP
Measured: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
heart rate(HR)
HR
Measured: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
respiratory rate(RR)
RR
Measured: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
Length of hospital stay
Length of hospital stay
Measured: Length of hospital stay, an arverage of 2 weeks
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 3 weeks and 6 weeks after surgery
postoperative nausea and vomiting(PONV)
0, absent; 1, nausea but not requiring treatment; 2, nausea requiring treatment; and 3, vomiting
Measured: within 48 hours postoperatively
The presence of respiratory depression
respiratory rate <10 breaths per minute or SpO2 was<90 %
Measured: within 48 hours postoperatively
The incidence of haematoma, wound infection or gastric ulcers
side effects
Measured: during hospitalization, within 2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study startDec 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (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.
- 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
- 100 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
- NCT04141319
- Sponsor's protocol ID
- KY-2018-034-02-6
- Status last verified
- Jan 2020
- First submitted
- 20 Oct 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Vacas S, Van de Wiele B. Designing a pain management protocol for craniotomy: A narrative review and consideration of promising practices. Surg Neurol Int. 2017 Dec 6;8:291. doi: 10.4103/sni.sni_301_17. eCollection 2017.
PubMed 29285407Andersen KV, Nikolajsen L, Haraldsted V, Odgaard A, Soballe K. Local infiltration analgesia for total knee arthroplasty: should ketorolac be added? Br J Anaesth. 2013 Aug;111(2):242-8. doi: 10.1093/bja/aet030. Epub 2013 Mar 20.
PubMed 23514638Solovyova O, Lewis CG, Abrams JH, Grady-Benson J, Joyce ME, Schutzer SF, Arumugam S, Caminiti S, Sinha SK. Local infiltration analgesia followed by continuous infusion of local anesthetic solution for total hip arthroplasty: a prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 2013 Nov 6;95(21):1935-41. doi: 10.2106/JBJS.L.00477.
PubMed 24196463Song J, Li L, Yu P, Gao T, Liu K. Preemptive scalp infiltration with 0.5% ropivacaine and 1% lidocaine reduces postoperative pain after craniotomy. Acta Neurochir (Wien). 2015 Jun;157(6):993-8. doi: 10.1007/s00701-015-2394-8. Epub 2015 Apr 7.
PubMed 25845547
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS)
- ClinicalTrials.gov ID
- NCT04141319
- Acronym / sponsor ID
- KY-2018-034-02-6
- Conditions
- Pain, Supratentorial Brain Tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Oct 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.
The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical study to compare the efficacy and safety of pre-emptive scalp infiltration with ropivacaine plus ketorolac and ropivacaine alone for postoperative pain relief in adults undergoing elective supratentorial craniotomies.
Detailed description
The proposed study will be a single-center, prospective, randomized, open-label, blinded-endpoint clinical trial designed to test the hypothesis that the addition of ketorolac to pre-emptive scalp infiltration analgesia can significantly improve analgesia after craniotomies. One hundred participants will be randomized to the ketorolac group or the control group. Patients in the ketorolac group will receive pre-emptive scalp infiltration with opivacaine,ketorolac and epinephrine while patients in the control group will receive pre-emptive scalp infiltration with ropivacaine and epinephrine.The primary outcome measure will be cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The ketorolac group | Experimental | Drug: Ketorolac, Drug: Ropivacaine, Drug: EpinephrinePatients assigned to the ketorolac group will receive pre-emptive scalp infiltration with 30ml of local infiltration solution containing 60 mg ropivacaine, 6 mg ketorolac and 0.1mg epinephrine. |
| The control group | Active comparator | Drug: Ropivacaine, Drug: EpinephrineIn the control group, preoperative peri-incisional scalp infiltration will be performed using 30ml of 60 mg ropivacaine and 0.1mg epinephrine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled for elective supratentorial tumour resection;
- Planned general anaesthesia;
- American Society of Anesthesiologists (ASA) physical status I - II;
- Age ranging from 18 to 65 years old;
- Participates required to fix their head in a head clamp intraoperatively;
Key exclusion criteria (21 listed)
- Allergy/intolerance to study drugs including anesthetic drugs, ketorolac and epinephrine;
- Expected delayed extubation or no plan to extubate;
- History of neurosurgeries;
- Long-term use of analgesics and sedatives (more than 2 weeks)
- Receiving any painkiller within 24 h before the operation;
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 |
|---|---|---|
| Ketorolac30ml of local infiltration solution containing 60mg ropivacaine | Drug | The ketorolac group |
| Ropivacaine30ml of local infiltration solution containing 6mg ketorolac | Drug | The control group, The ketorolac group |
| Epinephrine30ml of local infiltration solution containing 0.1mg epinephrine | Drug | The control group, The ketorolac group |
Primary outcome
cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively
Time frame: 0 to 48 hours postoperatively
The primary outcome measure will be cumulative doses of PCA butorphanol consumption from 0 to 48 h postoperatively
14 secondary outcomes
The time to first request for patient-controlled analgesia butorphanol
Time frame: Within 48hours postoperatively
frequency of pressing patient-controlled analgesia pump
Time frame: Within 48hours postoperatively
numeral rating scale (NRS) Score
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 postoperatively
Pain control satisfaction score (PCSS) postoperatively
Time frame: at 24 hours, 48 hours, 72 hours, 1 week, 1 month, 3 months and 6 months
Ramsay sedation score (RSS)
Time frame: at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours and 72 hours postoperatively
pulse oxygen saturation(SpO2)
Time frame: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
mean arterial blood pressure(MAP)
Time frame: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
heart rate(HR)
Time frame: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
respiratory rate(RR)
Time frame: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
Length of hospital stay
Time frame: Length of hospital stay, an arverage of 2 weeks
Wound healing score
Time frame: at 3 weeks and 6 weeks after surgery
postoperative nausea and vomiting(PONV)
Time frame: within 48 hours postoperatively
The presence of respiratory depression
Time frame: within 48 hours postoperatively
The incidence of haematoma, wound infection or gastric ulcers
Time frame: during hospitalization, within 2 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Background: PubMed 29285407Vacas S, Van de Wiele B. Designing a pain management protocol for craniotomy: A narrative review and consideration of promising practices. Surg Neurol Int. 2017 Dec 6;8:291. doi: 10.4103/sni.sni_301_17. eCollection 2017.
- Background: PubMed 23514638Andersen KV, Nikolajsen L, Haraldsted V, Odgaard A, Soballe K. Local infiltration analgesia for total knee arthroplasty: should ketorolac be added? Br J Anaesth. 2013 Aug;111(2):242-8. doi: 10.1093/bja/aet030. Epub 2013 Mar 20.
- Background: PubMed 24196463Solovyova O, Lewis CG, Abrams JH, Grady-Benson J, Joyce ME, Schutzer SF, Arumugam S, Caminiti S, Sinha SK. Local infiltration analgesia followed by continuous infusion of local anesthetic solution for total hip arthroplasty: a prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 2013 Nov 6;95(21):1935-41. doi: 10.2106/JBJS.L.00477.
- Background: PubMed 25845547Song J, Li L, Yu P, Gao T, Liu K. Preemptive scalp infiltration with 0.5% ropivacaine and 1% lidocaine reduces postoperative pain after craniotomy. Acta Neurochir (Wien). 2015 Jun;157(6):993-8. doi: 10.1007/s00701-015-2394-8. Epub 2015 Apr 7.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac, Ropivacaine and Epinephrine in people with Pain and Supratentorial Brain Tumor, run by Beijing Tiantan Hospital.
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 6 inclusion and 21 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 22 Jan 2020. 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.
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 (+8613611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively (time frame: 0 to 48 hours postoperatively). 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 NCT04141319, 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 22 Jan 2020.