Pain, PostoperativePhase 4NCT03618264

Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy

A Phase 4 study testing Miscible liquid of dexamethasone and ropivacaine and Ropivacaine in people with Pain, Postoperative and Post-Craniotomy Headache, 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, Post-Craniotomy Headache
What is being tested?: Miscible liquid of dexamethasone and ropivacaine and Ropivacaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteChina
Study dates: 4 Apr 2019to 13 Feb 2020
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 a supratentorial tumour under general anaesthesia;
American Society of Anesthesiologists (ASA) physical status of I or II;
Participates required to fix their head in a head clamp intraoperatively;
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, dexamethasone 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, 100050

Other trials in China

About this study

Official title: Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine vs. Ropivacaine for Relief of Postoperative Pain After Craniotomy in Adults

A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. As a result, adequate pain control is essential for patients' prognosis and their postoperative life quality. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, 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. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Thus, Investigators suppose that pre-emptive scalp infiltration with steroid (dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Conditions: Pain, Postoperative, Post-Craniotomy Headache
Being tested: Miscible liquid of dexamethasone and ropivacaine, Ropivacaine
Keywords: Postoperative Pain, Post-Craniotomy Headache, Dexamethasone, Ropivacaine, Pre-emptive 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.

Miscible liquid of dexamethasone and ropivacaineDrug
Intervention in this study will be peri-incisional scalp infiltration with dexamethasone, ropivacaine and normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter 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.
RopivacaineDrug
Intervention in this study will be peri-incisional scalp infiltration with ropivacaine for participants who will undergo elective craniotomy. The local infiltration solution containing 5mg ropivacaine per milliliter 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 groups in NCT03618264
Study group	Role	What they receive
Dexamethasone plus Ropivacaine group	Experimental	Participates received peri-incisional scalp infiltration of a miscible liquid of dexamethasone and ropivacaine. The local infiltration miscible liquid containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter Receives: Drug: Miscible liquid of dexamethasone and ropivacaine
Ropivacaine group	Active comparator	Participates received peri-incisional scalp infiltration of 5mg/mL ropivacaine. Receives: Drug: Ropivacaine

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 in which the bolus dose of sufentanil will be set as 2 μg with a lockout interval of 10 min and the maximum dose will be limited as 8 μg per hour. If the participates feel inadequate analgesia after 5 times of sufentanil bolus, the bolus dose will be increased to 3 μg and the maximum dose will be increased to 12 μg per hour.
Measured: Within 48 hours after the operation

Secondary outcomes (18)

The number of participants who have no sufentanil consumption
The number of participants who have not pushed the button of patient-controlled analgesia pump. Both of the initial dose and background infusion of the patient-controlled analgesia pump in this study will be set as 0. Participates will be advised to push the analgesic demand button if they feel pain.
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 after the operation
Numerical rating scale of pain
Pain was assessed after surgery by a 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
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
Heart rate
Measured: Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Mean arterial pressure
Measured: Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and 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
Patient satisfactory scale (PSS)
0 for unsatisfactory, and 10 for very satisfied
Measured: At 48 hours, 1 week, 1 month, 3 months and 6 months after surgery
The total consumption of opioids during the operation
Measured: During procedure
The total consumption of anaesthetic during the operation
Measured: During procedure
The duration of hospitalization after the operation
Measured: Approximately 2 weeks after the operation
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
Incisional related adverse events Incisional related adverse events
Including delayed incisional healing, incisional infection, intracranial infection, scar healing
Measured: Within 1 month 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 3 weeks and 6 weeks after surgery
Patient and Observer Scar Assessment Scale
The Patient and Observer Scar Assessment Scale includes subjective symptoms of pain and pruritus and consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale. It assesses vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). and it incorporates patient assessments of pain, itching, color, stiffness, thickness, relief and overall opinion. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).
Measured: At 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 201913 Feb 2020

First posted7 Aug 2018
Study start4 Apr 2019
Primary completion15 Aug 2019
Study completion13 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)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: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03618264
Sponsor's protocol ID: KY 2018-034-02-1
Status last verified: Feb 2020
First submitted: 30 Jul 2018
Last updated: 18 Feb 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 25903913
Vallapu S, Panda NB, Samagh N, Bharti N. Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthetic Agent in Scalp Block and Scalp Infiltration to Control Postcraniotomy Pain: A Double-Blind Randomized Trial. J Neurosci Rural Pract. 2018 Jan-Mar;9(1):73-79. doi: 10.4103/jnrp.jnrp_310_17.
PubMed 29456348
Tsaousi 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 27996204
Chowdhury T, Garg R, Sheshadri V, Venkatraghavan L, Bergese SD, Cappellani RB, Schaller B. Perioperative Factors Contributing the Post-Craniotomy Pain: A Synthesis of Concepts. Front Med (Lausanne). 2017 Mar 1;4:23. doi: 10.3389/fmed.2017.00023. eCollection 2017.
PubMed 28299313
Akcil EF, Dilmen OK, Vehid H, Ibisoglu LS, Tunali Y. Which one is more effective for analgesia in infratentorial craniotomy? The scalp block or local anesthetic infiltration. Clin Neurol Neurosurg. 2017 Mar;154:98-103. doi: 10.1016/j.clineuro.2017.01.018. Epub 2017 Jan 30.
PubMed 28183036
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
Mordhorst C, Latz B, Kerz T, Wisser G, Schmidt A, Schneider A, Jahn-Eimermacher A, Werner C, Engelhard K. Prospective assessment of postoperative pain after craniotomy. J Neurosurg Anesthesiol. 2010 Jul;22(3):202-6. doi: 10.1097/ANA.0b013e3181df0600.
PubMed 20479664
Rahimi 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
Misra S, Koshy T, Suneel PR. Oral clonidine attenuates the fall in mean arterial pressure due to scalp infiltration with epinephrine-lidocaine solution in patients undergoing craniotomy: a prospective, randomized, double-blind, and placebo controlled trial. J Neurosurg Anesthesiol. 2009 Oct;21(4):297-301. doi: 10.1097/ANA.0b013e3181ac7a31.
PubMed 19955891
Zhao C, Wang S, Pan Y, Ji N, Luo F. Pre-Emptive Incision-Site Infiltration with Ropivacaine Plus Dexamethasone for Postoperative Pain After Supratentorial Craniotomy: A Prospective Randomized Controlled Trial. J Pain Res. 2021 Apr 19;14:1071-1082. doi: 10.2147/JPR.S300943. eCollection 2021.
PubMed 33907455

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 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine vs. Ropivacaine for Relief of Postoperative Pain After Craniotomy in Adults
ClinicalTrials.gov ID: NCT03618264
Acronym / sponsor ID: KY 2018-034-02-1
Conditions: Pain, Postoperative, Post-Craniotomy Headache
Keywords: Postoperative Pain, Post-Craniotomy Headache, Dexamethasone, Ropivacaine, Pre-emptive Scalp Infiltration
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Beijing Tiantan HospitalUniversity, hospital or other
Study start: 4 Apr 2019 (actual)
Primary completion: 15 Aug 2019 (actual)
Study completion: 13 Feb 2020 (actual)
First posted: 7 Aug 2018 (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
Dexamethasone plus Ropivacaine group	Experimental	Drug: Miscible liquid of dexamethasone and ropivacaineParticipates received peri-incisional scalp infiltration of a miscible liquid of dexamethasone and ropivacaine. The local infiltration miscible liquid containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter
Ropivacaine group	Active comparator	Drug: RopivacaineParticipates received peri-incisional scalp infiltration of 5mg/mL ropivacaine.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patients scheduled for elective craniotomy for resection of a supratentorial tumour under general anaesthesia;
American Society of Anesthesiologists (ASA) physical status of I or II;
Participates required to fix their head in a head clamp intraoperatively;
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
Miscible liquid of dexamethasone and ropivacaineIntervention in this study will be peri-incisional scalp infiltration with dexamethasone, ropivacaine and normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter 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	Dexamethasone plus Ropivacaine group
RopivacaineIntervention in this study will be peri-incisional scalp infiltration with ropivacaine for participants who will undergo elective craniotomy. The local infiltration solution containing 5mg ropivacaine per milliliter 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	Ropivacaine 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 in which the bolus dose of sufentanil will be set as 2 μg with a lockout interval of 10 min and the maximum dose will be limited as 8 μg per hour. If the participates feel inadequate analgesia after 5 times of sufentanil bolus, the bolus dose will be increased to 3 μg and the maximum dose will be increased to 12 μg per hour.

18 secondary outcomes

The number of participants who have no sufentanil 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 after the operation
Numerical rating scale of pain
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
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
Heart rate
Time frame: Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Mean arterial pressure
Time frame: Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and 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
Patient satisfactory scale (PSS)
Time frame: At 48 hours, 1 week, 1 month, 3 months and 6 months after surgery
The total consumption of opioids during the operation
Time frame: During procedure
The total consumption of anaesthetic during the operation
Time frame: During procedure
The duration of hospitalization after the operation
Time frame: Approximately 2 weeks after the operation
The World Health Organization Quality of Life (WHOQOL)-BREF
Time frame: At 1 month, 3 months and 6 months after surgery
Incisional related adverse events Incisional related adverse events
Time frame: Within 1 month after surgery
Wound Healing Score
Time frame: At 3 weeks and 6 weeks after surgery
Patient and Observer Scar Assessment Scale
Time frame: At 6 months 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 18 Feb 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 29456348Vallapu S, Panda NB, Samagh N, Bharti N. Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthetic Agent in Scalp Block and Scalp Infiltration to Control Postcraniotomy Pain: A Double-Blind Randomized Trial. J Neurosci Rural Pract. 2018 Jan-Mar;9(1):73-79. doi: 10.4103/jnrp.jnrp_310_17.
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 28299313Chowdhury T, Garg R, Sheshadri V, Venkatraghavan L, Bergese SD, Cappellani RB, Schaller B. Perioperative Factors Contributing the Post-Craniotomy Pain: A Synthesis of Concepts. Front Med (Lausanne). 2017 Mar 1;4:23. doi: 10.3389/fmed.2017.00023. eCollection 2017.
Background: PubMed 28183036Akcil EF, Dilmen OK, Vehid H, Ibisoglu LS, Tunali Y. Which one is more effective for analgesia in infratentorial craniotomy? The scalp block or local anesthetic infiltration. Clin Neurol Neurosurg. 2017 Mar;154:98-103. doi: 10.1016/j.clineuro.2017.01.018. Epub 2017 Jan 30.
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 20479664Mordhorst C, Latz B, Kerz T, Wisser G, Schmidt A, Schneider A, Jahn-Eimermacher A, Werner C, Engelhard K. Prospective assessment of postoperative pain after craniotomy. J Neurosurg Anesthesiol. 2010 Jul;22(3):202-6. doi: 10.1097/ANA.0b013e3181df0600.
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.
Background: PubMed 19955891Misra S, Koshy T, Suneel PR. Oral clonidine attenuates the fall in mean arterial pressure due to scalp infiltration with epinephrine-lidocaine solution in patients undergoing craniotomy: a prospective, randomized, double-blind, and placebo controlled trial. J Neurosurg Anesthesiol. 2009 Oct;21(4):297-301. doi: 10.1097/ANA.0b013e3181ac7a31.
Derived from this study: PubMed 33907455Zhao C, Wang S, Pan Y, Ji N, Luo F. Pre-Emptive Incision-Site Infiltration with Ropivacaine Plus Dexamethasone for Postoperative Pain After Supratentorial Craniotomy: A Prospective Randomized Controlled Trial. J Pain Res. 2021 Apr 19;14:1071-1082. doi: 10.2147/JPR.S300943. eCollection 2021.
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, MD 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?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 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 18 Feb 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?

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 NCT03618264, which also lists 10 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 18 Feb 2020.