Pain, PostoperativePhase 4NCT06069804

Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults

A Phase 4 study testing The TR group and The R group in people with Pain, Postoperative, run by Beijing Tiantan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Pain, Postoperative
What is being tested?: The TR group and The R group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteChina
Study dates: 7 Oct 2023to 31 Dec 2023
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, triamcinolone acetonide 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.

China1 site

Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050

Other trials in China

About this study

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 triamcinolone acetonide as an adjuvant to local anesthetics intra-articular injected locally ameliorated pain intensity inarthroscopic knee surgery or total knee arthroplasty. However, there has not been reported about local application of triamcinolone acetonide on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (triamcinolone acetonide) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Conditions: Pain, Postoperative
Being tested: The TR group, The R group
Keywords: Postoperative Pain;, Post-Craniotomy, Pre-emptive Scalp Infiltration, Ropivacaine, Triamcinolone Acetonide
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 TR groupDrug
Miscible liquid of triamcinolone acetonide and ropivacaine in this study will be peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 0.25ml triamcinolone acetonide (40mg/ml), plus 10 ml saline miscible liquids for participants who will undergo elective craniotomy. Local infiltration of the study solution was performed by the neurosurgeon after induction of general anesthesia and intubation, once all equipment and catheters had been placed, during stable and steady state anesthetic conditions before skin incision. The solution was infiltrated with a 22-gauge needle introduced into the skin at a 45° angle throughout the entire thickness of the scalp along the planned incision site and the head-holder sites, by the same neurosurgeon. The total volume of the study solution used for each patient was determined by the neurosurgeon mainly based on the length of the incision and recorded by the investigator.
The R groupDrug
Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10 ml saline miscible liquids for participants who will undergo elective craniotomy. Local infiltration of the study solution was performed by the neurosurgeon after induction of general anesthesia and intubation, once all equipment and catheters had been placed, during stable and steady state anesthetic conditions before skin incision. The solution was infiltrated with a 22-gauge needle introduced into the skin at a 45° angle throughout the entire thickness of the scalp along the planned incision site and the head-holder sites, by the same neurosurgeon. The total volume of the study solution used for each patient was determined by the neurosurgeon mainly based on the length of the incision and recorded by the investigator.

Study groups in NCT06069804
Study group	Role	What they receive
The TR group	Experimental	The respective drugs to be used for incision-site infiltration were prepared by an independent study investigator in the two groups: Participates will receive peri-incisional scalp infiltration with10 mg triamcinolone acetonide, 150 mg ropivacaine diluted to a total volume of 30 mL in 0.9% saline . The concentration of ropivacaine was 0.5% in both groups. The anesthesia protocol and monitoring were standardized for all patients. Monitoring, including blood pressure (BP), heart rate (HR), 5-lead electrocardiography (ECG), peripheral oxygen saturation (SpO2) and bispectral index (BIS) were continuously performed. Receives: Drug: The TR group
The R group	Active comparator	The respective drugs to be used for incision-site infiltration were prepared by an independent study investigator in the two groups: Participates will receive peri-incisional scalp infiltration with 150 mg ropivacaine diluted to a total volume of 30 mL in 0.9% saline in the control group. The concentration of ropivacaine was 0.5% in both groups. The anesthesia protocol and monitoring were standardized for all patients. Monitoring, including blood pressure (BP), heart rate (HR), 5-lead electrocardiography (ECG), peripheral oxygen saturation (SpO2) and bispectral index (BIS) were continuously performed. Receives: Drug: The R group

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative sufentanil 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 (8)

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,
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
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
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
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.

7 Oct 202331 Dec 2023

First posted6 Oct 2023
Study start7 Oct 2023
Primary completion31 Dec 2023
Study completion31 Dec 2023

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: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06069804
Sponsor's protocol ID: KY 2018-034-02-4
Status last verified: Apr 2024
First submitted: 24 Sep 2023
Last updated: 3 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
PubMed 17410701
Dunn 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 27604271
Chaki T, Sugino S, Janicki PK, Ishioka Y, Hatakeyama Y, Hayase T, Kaneuchi-Yamashita M, Kohri N, Yamakage M. Efficacy and Safety of a Lidocaine and Ropivacaine Mixture for Scalp Nerve Block and Local Infiltration Anesthesia in Patients Undergoing Awake Craniotomy. J Neurosurg Anesthesiol. 2016 Jan;28(1):1-5. doi: 10.1097/ANA.0000000000000149.
PubMed 25493926
Penning LI, de Bie RA, Walenkamp GH. Subacromial triamcinolone acetonide, hyaluronic acid and saline injections for shoulder pain an RCT investigating the effectiveness in the first days. BMC Musculoskelet Disord. 2014 Oct 23;15:352. doi: 10.1186/1471-2474-15-352.
PubMed 25341673
Wang JJ, Ho ST, Lee SC, Tang JJ, Liaw WJ. Intraarticular triamcinolone acetonide for pain control after arthroscopic knee surgery. Anesth Analg. 1998 Nov;87(5):1113-6. doi: 10.1097/00000539-199811000-00024.
PubMed 9806691
Sean VW, Chin PL, Chia SL, Yang KY, Lo NN, Yeo SJ. Single-dose periarticular steroid infiltration for pain management in total knee arthroplasty: a prospective, double-blind, randomised controlled trial. Singapore Med J. 2011 Jan;52(1):19-23.
PubMed 21298236
Wesley CK, Teo LH, Xu T, Unger RH, Unger WP. The influence of peri-incisional triamcinolone acetonide injection on wound edge apposition. J Dermatolog Treat. 2014 Aug;25(4):345-9. doi: 10.3109/09546634.2012.755253. Epub 2013 Feb 3.
PubMed 23210735

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults
ClinicalTrials.gov ID: NCT06069804
Acronym / sponsor ID: KY 2018-034-02-4
Conditions: Pain, Postoperative
Keywords: Postoperative Pain;, Post-Craniotomy, Pre-emptive Scalp Infiltration, Ropivacaine, Triamcinolone Acetonide
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Beijing Tiantan HospitalUniversity, hospital or other
Study start: 7 Oct 2023 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 6 Oct 2023 (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.

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 TR group	Experimental	Drug: The TR groupThe respective drugs to be used for incision-site infiltration were prepared by an independent study investigator in the two groups: Participates will receive peri-incisional scalp infiltration with10 mg triamcinolone acetonide, 150 mg ropivacaine diluted to a total volume of 30 mL in 0.9% saline . The concentration of ropivacaine was 0.5% in both groups. The anesthesia protocol and monitoring were standardized for all patients. Monitoring, including blood pressure (BP), heart rate (HR), 5-lead electrocardiography (ECG), peripheral oxygen saturation (SpO2) and bispectral index (BIS) were continuously performed.
The R group	Active comparator	Drug: The R groupThe respective drugs to be used for incision-site infiltration were prepared by an independent study investigator in the two groups: Participates will receive peri-incisional scalp infiltration with 150 mg ropivacaine diluted to a total volume of 30 mL in 0.9% saline in the control group. The concentration of ropivacaine was 0.5% in both groups. The anesthesia protocol and monitoring were standardized for all patients. Monitoring, including blood pressure (BP), heart rate (HR), 5-lead electrocardiography (ECG), peripheral oxygen saturation (SpO2) and bispectral index (BIS) were continuously performed.

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 TR groupMiscible liquid of triamcinolone acetonide and ropivacaine in this study will be peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 0.25ml triamcinolone acetonide (40mg/ml), plus 10 ml saline miscible liquids for participants who will undergo elective craniotomy. Local infiltration of the study solution was performed by the neurosurgeon after induction of general anesthesia and intubation, once all equipment and catheters had been placed, during stable and steady state anesthetic conditions before skin incision. The solution was infiltrated with a 22-gauge needle introduced into the skin at a 45° angle throughout the entire thickness of the scalp along the planned incision site and the head-holder sites, by the same neurosurgeon. The total volume of the study solution used for each patient was determined by the neurosurgeon mainly based on the length of the incision and recorded by the investigator.	Drug	The TR group
The R groupMiscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10 ml saline miscible liquids for participants who will undergo elective craniotomy. Local infiltration of the study solution was performed by the neurosurgeon after induction of general anesthesia and intubation, once all equipment and catheters had been placed, during stable and steady state anesthetic conditions before skin incision. The solution was infiltrated with a 22-gauge needle introduced into the skin at a 45° angle throughout the entire thickness of the scalp along the planned incision site and the head-holder sites, by the same neurosurgeon. The total volume of the study solution used for each patient was determined by the neurosurgeon mainly based on the length of the incision and recorded by the investigator.	Drug	The R group

Primary outcome

Cumulative sufentanil 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.

8 secondary outcomes

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,
Postoperative nausea and vomiting
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
The times of emergency reducing blood pressure after the operation
Time frame: Within 48 hours after the operation
The total consumption of opioids during the operation
Time frame: During procedure
The length of stay
Time frame: Approximately 2 weeks after the surgery
Wound Healing Score
Time frame: At 1 month after surgery

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 3 Apr 2024.
Background: PubMed 17410701Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
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 25493926Chaki T, Sugino S, Janicki PK, Ishioka Y, Hatakeyama Y, Hayase T, Kaneuchi-Yamashita M, Kohri N, Yamakage M. Efficacy and Safety of a Lidocaine and Ropivacaine Mixture for Scalp Nerve Block and Local Infiltration Anesthesia in Patients Undergoing Awake Craniotomy. J Neurosurg Anesthesiol. 2016 Jan;28(1):1-5. doi: 10.1097/ANA.0000000000000149.
Background: PubMed 25341673Penning LI, de Bie RA, Walenkamp GH. Subacromial triamcinolone acetonide, hyaluronic acid and saline injections for shoulder pain an RCT investigating the effectiveness in the first days. BMC Musculoskelet Disord. 2014 Oct 23;15:352. doi: 10.1186/1471-2474-15-352.
Background: PubMed 9806691Wang JJ, Ho ST, Lee SC, Tang JJ, Liaw WJ. Intraarticular triamcinolone acetonide for pain control after arthroscopic knee surgery. Anesth Analg. 1998 Nov;87(5):1113-6. doi: 10.1097/00000539-199811000-00024.
Background: PubMed 21298236Sean VW, Chin PL, Chia SL, Yang KY, Lo NN, Yeo SJ. Single-dose periarticular steroid infiltration for pain management in total knee arthroplasty: a prospective, double-blind, randomised controlled trial. Singapore Med J. 2011 Jan;52(1):19-23.
Background: PubMed 23210735Wesley CK, Teo LH, Xu T, Unger RH, Unger WP. The influence of peri-incisional triamcinolone acetonide injection on wound edge apposition. J Dermatolog Treat. 2014 Aug;25(4):345-9. doi: 10.3109/09546634.2012.755253. Epub 2013 Feb 3.
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 TR group and The R 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: finished, as of the sponsor's last update on 3 Apr 2024. 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?

Cumulative sufentanil 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 NCT06069804, 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 Apr 2024.