Pain, PostoperativeNCT03915639
Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache
A study testing Peri-incisional injection in people with Pain, Postoperative, run by Beijing Tiantan Hospital.
Trial summary
Postcraniotomy headache (PCH) has been underestimated for the past decades. However, current treatments for PCH are either considered insufficient or accompanied by severe side-effects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Peri-incisional injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having signed the informed consent,
- age 18-80 yrs,
- American Society of Anaesthesiologists (ASA) physical status of I or II,
- scheduled elective supratentorial craniotomy,
- planned head fixation in a skull clamp.
Who cannot join
- Allergy to LAs,
- alcohol abuse,
- intracranial hypertension,
- active psychiatric disorders,
- uncontrolled epilepsy,
- chronic opioid use (more than 2 weeks),
Show all 14Show fewer
- undergoing a revision craniotomy,
- high probability of having postoperative radio- or chemotherapy,
- expectation of delayed extubation or no planned extubation,
- pregnancy or breastfeeding during the study,
- extreme body mass index (BMI) (less than 15 or more than 40),
- preoperative Glasgow Coma Scale less than 15,
- undergoing emergency or awake craniotomy surgery,
- inability to understand the use of the NRS or the PCA. (Patients are informed of the instructions of NRS (from 0 to 10, where 0 and 10 represent no pain and the worst imaginable pain, respectively) and PCA after signing the informed consent the day before the operation. Patients who cannot understand the instruction of NRS and PCA will be excluded from the study.)
Trial locations and contacts
No sites are listed yet.
About this study
Postcraniotomy headache (PCH) has been underestimated for the past decades. However, current treatments for PCH are either considered insufficient or accompanied by severe side-effects. Some studies revealed that peri-incisional injection of a mixed cocktail that contains ropivacaine, epinephrine, ketorolac, and methylprednisolone showed significant efficacy in relieving postoperative pain after total hip or knee arthroplasty. Previous literature reported that the cause of PCH was related to incision of the scalp and dura, which is considered similar to causes to postoperative pain after total hip or knee arthroplasty. Thus, investigators suppose that the cocktail mixture can better relieve PCH in adults.
- Conditions
- Pain, Postoperative
- Being tested
- Peri-incisional injection
- Keywords
- Post-Craniotomy Headache, Postoperative Pain, Cocktail, Analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-incisional injectionProcedure or surgery
The surgeons are planned to inject the cocktail mixture or ropivacaine to muscles and the subcutaneous tissue beneath the fixation sites and incision site using a 22-gauge needle in a sterile fashion prior to skin incision.
| Study group | Role | What they receive |
|---|---|---|
| Cocktail | Experimental | Participants in Group Cocktail are planned to infiltrate the head fixation sites after intubation and peri-incisionally prior to skin incision. The infiltration will be performed by the attending neurosurgeon. The muscle and the subcutaneous tissue beneath the fixation sites and incision site will be fully irrigated with the multimodal cocktail. Receives: Procedure: Peri-incisional injection |
| Ropivacaine | Active comparator | Participants in Group Ropivacaine are planned to infiltrate the head fixation sites after intubation and peri-incisionally prior to skin incision. The infiltration will be performed by the attending neurosurgeon. The muscle and the subcutaneous tissue beneath the fixation sites and incision site will be fully irrigated with ropivacaine. Receives: Procedure: Peri-incisional injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative morphine consumption
cumulative morphine consumption through PCA within 24 hours after recovery
Measured: 24 hours after recovery
Secondary outcomes (11)
Postoperative 0-10 Numeric Rating Score
Numeric Rating Score is a common used scale in evaluating patients' pain intensity in clinical trials. The scale in the present trial is ranged from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher values represent worse pain intensity.
Measured: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery and 3 and 6 months after craniotomy
Rate of post-operative opioid-related side effects
Post-operative opioid-related side effects include post-operative opioid-induced oversedation, opioid-induced respiratory depression, pruritus, drowsiness, dizziness, blurred vision, and rash.
Opioid-induced oversedation will be evaluated using the Pasero Opioid-induced Sedation Scale (POSS).
- Awake and alert,
- Slightly drowsy, easily aroused,
- Frequently drowsy, arousable, drift off to sleep during a conversation,
- Somnolent, minimal or no response to verbal or physical stimulation A POSS score of 3 or 4 is defined as oversedation.
Opioid-induced respiratory depression (defined as respiratory rate <8/min and/or oxygen saturation <90% and/or apnoea ≥10 s, excessive sedation or upper airway obstruction.
Measured: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery
Time interval to first PCA demand
The PCA device will automatically record the time interval to the first PCA demand based on a specially designed algorithm
Measured: within 24 hours after recovery
Total PCA press counts
The PCA device will automatically record the total press counts based on a specially designed algorithm.
Measured: within 24 hours after recovery
Total rescue medication usage
When PCA is not enough for analgesia, rescue medication will be used for relieving severe pain. The total rescue medication usage within 24 hours after recovery will be recorded.
Measured: within 24 hours after recovery
Recovery
Time to PACU discharge, time to ambulation, and length of stay (LOS)
Measured: an average of 1 month
Wound Healing Score
Wound Healing Score worksheet for assessment of outcomes in scalp clip versus artery forceps groups in patients undergoing craniotomy.
The wound healing evaluation is based on skin healing, infection and hair regrowth.
For skin healing, 1 represents fully healed, 2 represents ≤3 cm in total not healed, 3 represents >3 cm not healed, 4 represents areas of necrosis ≤3 cm, and 5 represents areas of necrosis >3 cm.
For infection, 1 represents none, 2 represents ≤0.5-cm margin of redness , 3 represents more redness or superficial pus, 4 represents deep infection.
For hair regrowth, 1 represents even regrowth along wound, 2 represents ≤3 cm not regrowing , 3 represents 3-6 cm not regrowing, 4 represents >6 cm not regrowing.
Excellent wounds, total score of 3; Good wounds, Score 4-5; Suboptimal wounds, Score 6+
Measured: 3 and 6 weeks after craniotomy
The size of surgical incision
Recording the size of surgical incision (unit: centimeter)
Measured: at the end of the craniotomy
The duration of operation
Recording the duration of operation (unit:minute)
Measured: at the end of the craniotomy
Rate of postoperative complications
Postoperative complications include (1) Operative complications: intracranial infection, cerebral oedema, intracranial haematoma, CSF fistula, reoperation, reintubation and delayed extubation. incision infection, incision haematoma, delayed wound healing; (2) systemic complications: systemic infection, systemic inflammatory response syndrome and sepsis; (3) all-cause mortality
Measured: within 30 days after craniotomy
Postoperative antibiotic usage
postoperative antibiotic usage
Measured: within 30 days after craniotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study startApr 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915639
- Sponsor's protocol ID
- KY 2018-035-01
- Status last verified
- May 2020
- First submitted
- 9 Apr 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rocha-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 25903913Papangelou A, Radzik BR, Smith T, Gottschalk A. A review of scalp blockade for cranial surgery. J Clin Anesth. 2013 Mar;25(2):150-9. doi: 10.1016/j.jclinane.2012.06.024. Epub 2013 Jan 23.
PubMed 23352875Akhigbe T, Zolnourian A. Use of regional scalp block for pain management after craniotomy: Review of literature and critical appraisal of evidence. J Clin Neurosci. 2017 Nov;45:44-47. doi: 10.1016/j.jocn.2017.08.027. Epub 2017 Sep 8.
PubMed 28890034Artime CA, Aijazi H, Zhang H, Syed T, Cai C, Gumbert SD, Ferrario L, Normand KC, Williams GW, Hagberg CA. Scheduled Intravenous Acetaminophen Improves Patient Satisfaction With Postcraniotomy Pain Management: A Prospective, Randomized, Placebo-controlled, Double-blind Study. J Neurosurg Anesthesiol. 2018 Jul;30(3):231-236. doi: 10.1097/ANA.0000000000000461.
PubMed 29117012Schankin CJ, Gall C, Straube A. Headache syndromes after acoustic neuroma surgery and their implications for quality of life. Cephalalgia. 2009 Jul;29(7):760-71. doi: 10.1111/j.1468-2982.2008.01790.x. Epub 2009 Feb 23.
PubMed 19239675Flexman AM, Ng JL, Gelb AW. Acute and chronic pain following craniotomy. Curr Opin Anaesthesiol. 2010 Oct;23(5):551-7. doi: 10.1097/ACO.0b013e32833e15b9.
PubMed 20717011Kerr DR, Kohan L. Local infiltration analgesia: a technique for the control of acute postoperative pain following knee and hip surgery: a case study of 325 patients. Acta Orthop. 2008 Apr;79(2):174-83. doi: 10.1080/17453670710014950.
PubMed 18484242Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
PubMed 16651569Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.
PubMed 17823012Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11.
PubMed 23850410Milani P, Castelli P, Sola M, Invernizzi M, Massazza G, Cisari C. Multimodal Analgesia in Total Knee Arthroplasty: A Randomized, Double-Blind, Controlled Trial on Additional Efficacy of Periarticular Anesthesia. J Arthroplasty. 2015 Nov;30(11):2038-42. doi: 10.1016/j.arth.2015.05.035. Epub 2015 May 23.
PubMed 26072302Spangehl MJ, Clarke HD, Hentz JG, Misra L, Blocher JL, Seamans DP. The Chitranjan Ranawat Award: Periarticular injections and femoral & sciatic blocks provide similar pain relief after TKA: a randomized clinical trial. Clin Orthop Relat Res. 2015 Jan;473(1):45-53. doi: 10.1007/s11999-014-3603-0.
PubMed 24706022Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173.
PubMed 16452738
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache
- ClinicalTrials.gov ID
- NCT03915639
- Acronym / sponsor ID
- KY 2018-035-01
- Conditions
- Pain, Postoperative
- Keywords
- Post-Craniotomy Headache, Postoperative Pain, Cocktail, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Apr 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.
Postcraniotomy headache (PCH) has been underestimated for the past decades. However, current treatments for PCH are either considered insufficient or accompanied by severe side-effects. Some studies revealed that peri-incisional injection of a mixed cocktail that contains ropivacaine, epinephrine, ketorolac, and methylprednisolone showed significant efficacy in relieving postoperative pain after total hip or knee arthroplasty. Previous literature reported that the cause of PCH was related to incision of the scalp and dura, which is considered similar to causes to postoperative pain after total hip or knee arthroplasty. Thus, investigators suppose that the cocktail mixture can better relieve PCH in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cocktail | Experimental | Procedure: Peri-incisional injectionParticipants in Group Cocktail are planned to infiltrate the head fixation sites after intubation and peri-incisionally prior to skin incision. The infiltration will be performed by the attending neurosurgeon. The muscle and the subcutaneous tissue beneath the fixation sites and incision site will be fully irrigated with the multimodal cocktail. |
| Ropivacaine | Active comparator | Procedure: Peri-incisional injectionParticipants in Group Ropivacaine are planned to infiltrate the head fixation sites after intubation and peri-incisionally prior to skin incision. The infiltration will be performed by the attending neurosurgeon. The muscle and the subcutaneous tissue beneath the fixation sites and incision site will be fully irrigated with ropivacaine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having signed the informed consent,
- age 18-80 yrs,
- American Society of Anaesthesiologists (ASA) physical status of I or II,
- scheduled elective supratentorial craniotomy,
- planned head fixation in a skull clamp.
Key exclusion criteria (14 listed)
- Allergy to LAs,
- alcohol abuse,
- intracranial hypertension,
- active psychiatric disorders,
- uncontrolled epilepsy,
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 |
|---|---|---|
| Peri-incisional injectionThe surgeons are planned to inject the cocktail mixture or ropivacaine to muscles and the subcutaneous tissue beneath the fixation sites and incision site using a 22-gauge needle in a sterile fashion prior to skin incision. | Procedure or surgery | Cocktail, Ropivacaine |
Primary outcome
Cumulative morphine consumption
Time frame: 24 hours after recovery
cumulative morphine consumption through PCA within 24 hours after recovery
11 secondary outcomes
Postoperative 0-10 Numeric Rating Score
Time frame: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery and 3 and 6 months after craniotomy
Rate of post-operative opioid-related side effects
Time frame: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery
Time interval to first PCA demand
Time frame: within 24 hours after recovery
Total PCA press counts
Time frame: within 24 hours after recovery
Total rescue medication usage
Time frame: within 24 hours after recovery
Recovery
Time frame: an average of 1 month
Wound Healing Score
Time frame: 3 and 6 weeks after craniotomy
The size of surgical incision
Time frame: at the end of the craniotomy
The duration of operation
Time frame: at the end of the craniotomy
Rate of postoperative complications
Time frame: within 30 days after craniotomy
Postoperative antibiotic usage
Time frame: within 30 days after craniotomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- 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 23352875Papangelou A, Radzik BR, Smith T, Gottschalk A. A review of scalp blockade for cranial surgery. J Clin Anesth. 2013 Mar;25(2):150-9. doi: 10.1016/j.jclinane.2012.06.024. Epub 2013 Jan 23.
- Background: PubMed 28890034Akhigbe T, Zolnourian A. Use of regional scalp block for pain management after craniotomy: Review of literature and critical appraisal of evidence. J Clin Neurosci. 2017 Nov;45:44-47. doi: 10.1016/j.jocn.2017.08.027. Epub 2017 Sep 8.
- Background: PubMed 29117012Artime CA, Aijazi H, Zhang H, Syed T, Cai C, Gumbert SD, Ferrario L, Normand KC, Williams GW, Hagberg CA. Scheduled Intravenous Acetaminophen Improves Patient Satisfaction With Postcraniotomy Pain Management: A Prospective, Randomized, Placebo-controlled, Double-blind Study. J Neurosurg Anesthesiol. 2018 Jul;30(3):231-236. doi: 10.1097/ANA.0000000000000461.
- Background: PubMed 19239675Schankin CJ, Gall C, Straube A. Headache syndromes after acoustic neuroma surgery and their implications for quality of life. Cephalalgia. 2009 Jul;29(7):760-71. doi: 10.1111/j.1468-2982.2008.01790.x. Epub 2009 Feb 23.
- Background: PubMed 20717011Flexman AM, Ng JL, Gelb AW. Acute and chronic pain following craniotomy. Curr Opin Anaesthesiol. 2010 Oct;23(5):551-7. doi: 10.1097/ACO.0b013e32833e15b9.
- Background: PubMed 18484242Kerr DR, Kohan L. Local infiltration analgesia: a technique for the control of acute postoperative pain following knee and hip surgery: a case study of 325 patients. Acta Orthop. 2008 Apr;79(2):174-83. doi: 10.1080/17453670710014950.
- Background: PubMed 16651569Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
- Background: PubMed 17823012Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.
- Background: PubMed 23850410Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11.
- Background: PubMed 26072302Milani P, Castelli P, Sola M, Invernizzi M, Massazza G, Cisari C. Multimodal Analgesia in Total Knee Arthroplasty: A Randomized, Double-Blind, Controlled Trial on Additional Efficacy of Periarticular Anesthesia. J Arthroplasty. 2015 Nov;30(11):2038-42. doi: 10.1016/j.arth.2015.05.035. Epub 2015 May 23.
- Background: PubMed 24706022Spangehl MJ, Clarke HD, Hentz JG, Misra L, Blocher JL, Seamans DP. The Chitranjan Ranawat Award: Periarticular injections and femoral & sciatic blocks provide similar pain relief after TKA: a randomized clinical trial. Clin Orthop Relat Res. 2015 Jan;473(1):45-53. doi: 10.1007/s11999-014-3603-0.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Peri-incisional injection in people with Pain, Postoperative, 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 5 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 27 May 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.
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 (+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 morphine consumption (time frame: 24 hours after recovery). 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 NCT03915639, which also lists 13 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 27 May 2020.