Pain, PostoperativePhase 4NCT05693467

Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery

A Phase 4 study testing Dexamethasone palmitate emulsion(DXP) plus ropivacaine and Ropivacaine alone 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?: Dexamethasone palmitate emulsion(DXP) plus ropivacaine and Ropivacaine alone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 1 siteChina
Study dates: 1 Mar 2023to 30 Sep 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

Age 18-64 years;
Patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia
American Society of Anesthesiologists (ASA) physical status of I-III;
Anticipated full recovery and cooperation within 2 hours postoperatively.

Who cannot join

History of spinal surgery;
Inability to use a patient-controlled analgesia (PCA) pump or comprehend the pain visual analog scale (VAS);
Body mass index (BMI)<15kg/m2 or >35kg/m2;
Peri-incisional infection;
History of diabetes mellitus and other metabolic diseases;
History of severe cardiopulmonary, hepatic or renal dysfunction;

Show all 14Show fewer

Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 times normal value);
History of allergies to any of the study drugs;
History of alcohol or drugs abuse (more than 2 weeks), or use of any analgesic within 24h before surgery;
Use of systemic steroids within 1 week before surgery;
History of psychiatric disorders, chronic neck or back pain;
History of radiation therapy and chemotherapy or with a high probability of such treatment postoperatively;
Pregnant or breastfeeding;
Refusal to sign informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: Preemptive Co-infiltration of Dexamethasone Palmitate Emulsion With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery

Patients undergoing major spinal surgery usually experience moderate-to-severe postoperative pain. Inadequate pain control may lead to severe complications. Dexamethasone as an adjunctive infiltration to local anesthesia (LA) presented a superior analgesic benefit compared with LA alone in various types of surgeries. However, a recent meta-analysis showed that the additional analgesic effect of dexamethasone in incision/wound infiltration was only statistically significant, but not clinically significant, and the overall benefits were marginal. Compared with dexamethasone, dexamethasone palmitate emulsion (DXP) is a targeted lipo-steroid with stronger anti-inflammatory effect, longer-acting duration and fewer adverse effects. To date, no studies have evaluated the additive analgesia effects of DXP on incision infiltration in major spinal surgery. The purpose of this trial is to determine whether preemptive co-infiltration of DXP emulsion and ropivacaine in surgical incision will further reduce postoperative opioid requirements and pain score after spinal surgery than that of ropivacaine alone.

Conditions: Pain, Postoperative
Being tested: Dexamethasone palmitate emulsion(DXP) plus ropivacaine, Ropivacaine alone
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexamethasone palmitate emulsion(DXP) plus ropivacaineDrug
Also called DXP plus ropivacaine
The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of ropivacaine and dexamethasone palmitate emulsion(DXP). For local infiltration, a total of 30mL solution will be prepared for each group, which will include 2mL of DXP(4mg per 1mL) added to 20.5 mL of saline and 7.5mL of 1% ropivacaine added to 15mL of saline for Group A . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.
Ropivacaine aloneDrug
The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone. For local infiltration, a total of 30mL solution will be prepared for each group, which will include 7.5mL of ropivacaine added to 22.5mL of saline for Group B . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.

Study groups in NCT05693467
Study group	Role	What they receive
The dexamethasone palmitate emulsion(DXP) plus ropivacaine group	Experimental	The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of dexamethasone palmitate emulsion(DXP) and ropivacaine. Receives: Drug: Dexamethasone palmitate emulsion(DXP) plus ropivacaine
The ropivacaine alone group	Active comparator	The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone. Receives: Drug: Ropivacaine alone

What is being measured

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

The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump.
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) pump. Participates will be advised to push the analgesic demand button if they feel pain.
Measured: Within 24 hours after spinal surgery

Secondary outcomes (17)

The cumulative consumption of sufentanil via PCA pump between 24 hours and 48 hours postoperatively.
Patients will use PCA device for pain management within the the first 48 hours after surgery. When the patients feel pain, the PCA button will be pressed. When the patients feel no pain, the PCA button will not be pressed. The PCA pump will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.
Measured: Between 24 hours and 48 hours after spinal surgery
Number of patients without PCA press button
Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. When the patients feel no pain, the PCA button will not be pressed. The PCA pump will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.
Measured: Within 48 hours after spinal surgery
The time of first PCA demand
The first time that the participants press PCA button.
Measured: Within 48 hours after spinal surgery
The total number of PCA presses including both valid and invalid presses
The total number that participants press PCA button including valid and invalid presses
Measured: Within 48 hours after spinal surgery
Postoperative visual analogue scale (VAS) score during movement(VASm)
The pain will be assessed by VAS scores during movement (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)
Measured: At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively
Postoperative VAS score at rest(VASr)
The pain will be assessed by VAS scores at rest (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)
Measured: At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively
Total consumption of Tylenol as supplementary analgesia
During the initial postoperative 48 hours, when VAS>4 (either VASm or VASr) after pressing button four times with PCA pump for pain relief, patients will be treated for supplementary analgesia with oral Tylenol (Mallinckrodt Inc.), a combination of 5mg of oxycodone hydrochloride and 325mg paracetamol per tablet at a minimum interval of 6 hours. After the initial postoperative 48 hours, patients will be allowed to take oral Tylenol as needed (dose as previously described), until the end of the study (3-months follow-up).
Measured: Four separate postoperative periods ( 0- postoperative 48 hours, postoperative 48 hours-postoperative 2 weeks, postoperative 2 weeks-postoperative 1 month, and postoperative 1 month-postoperative 3 months)
Patient Satisfaction Score (PSS) with pain relief
4 scales; never, sometimes, usually or always
Measured: At 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks 1 month and 3 months postoperatively
Postoperative nausea and vomiting (PONV) score
The Postoperative Nausea and Vomiting (PONV) will be measured using an ordinal scale, with 0 indicating no nausea;
1, mild nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting.
Measured: At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively
Ramsay Sedation Scale (RSS)
The Ramsay Sedation Scale (RSS): A 6-point scale will be used to assess sedation levels, with 1 indicating agitated, anxious; 2, cooperative; 3, only responds to commands; 4, strong response to glabellar tapping or noisy stimulants; 5, weak response to glabellar tapping or noisy stimulants; 6, no response.
Measured: At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively
Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)
The POSAS consists of an Observer and a Patient Scale and includes a comprehensive list of items, based on clinically relevant scar characteristics. The observer scores six items: vascularization, pigmentation, thickness, surface roughness, pliability, and surface area. The patient scores six items: pain, pruritus, color, thickness, relief, and pliability. All included items are scored on the same polytomous 10-point scale, in which a score of 1 is given when the scar characteristic is comparable to normal skin and a score of 10 reflects the worst imaginable scar. All items are summed to give a total scar score, and therefore, a higher score represents a poorer scar quality.
Measured: At 2 weeks, 1 month and 3 months postoperatively
Rate of steroid-related side effects and complications
Steroid-related side effects (hyperglycemia, gastrointestinal bleeding, gastritis, etc.) or complications including any cardiac, respiratory, renal, neurologic, or infection complications occured during the hospitalization
Measured: Through the whole follow-up, an average of 3 months
Readmission rate within 3 months after spine surgery;
Patients readmitted within 3 months after spine surgery
Measured: Through the whole follow-up, within 3 months after spine surgery
Length of Postoperative Anesthesia Care Unit (PACU) stay
Time from arrival at PACU after tracheal extubation to transfer from PACU to the surgical ward (modified Aldrete score ≥9).
Measured: Approximately 30 minutes to 2 hours after surgery
Duration of hospitalization after surgery
Duration of hospitalization after surgery (time required from the end of surgery to discharge from the hospital).
Measured: Approximately 1-2 weeks after surgery
Total consumption of remifentanil during surgery
Total remifentanil dosages during surgery
Measured: During surgery
Total consumption of loxoprofen
Pain management will be provided via the sufentanil PCA device for the first 48 hours following surgery. After that, patients will switch to taking oral loxoprofen 60 mg at a minimum interval of 8 hours and a maximum 180mg per day as needed until discharge.
Measured: From postoperative 48 hours to approximately 1-2 weeks after surgery

Timeline

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

1 Mar 202330 Sep 2023

First posted23 Jan 2023
Study start1 Mar 2023
Primary completion30 Jun 2023
Study completion30 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)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: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05693467
Sponsor's protocol ID: KY-2019-112-02-3
Status last verified: Apr 2024
First submitted: 24 Dec 2022
Last updated: 16 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Lamperti M, Tufegdzic B, Avitsian R. Management of complex spine surgery. Curr Opin Anaesthesiol. 2017 Oct;30(5):551-556. doi: 10.1097/ACO.0000000000000494.
PubMed 28731875
Kjaergaard M, Moiniche S, Olsen KS. Wound infiltration with local anesthetics for post-operative pain relief in lumbar spine surgery: a systematic review. Acta Anaesthesiol Scand. 2012 Mar;56(3):282-90. doi: 10.1111/j.1399-6576.2011.02629.x. Epub 2012 Jan 19.
PubMed 22260370
Bai JW, An D, Perlas A, Chan V. Adjuncts to local anesthetic wound infiltration for postoperative analgesia: a systematic review. Reg Anesth Pain Med. 2020 Aug;45(8):645-655. doi: 10.1136/rapm-2020-101593. Epub 2020 May 30.
PubMed 32474417
Shrestha N, Han B, Wang X, Jia W, Luo F. Methylprednisolone as an Adjunct to Local Infiltration on Laminoplasty or Laminectomy before Wound Closure: A Randomized Controlled Trial. Pain Res Manag. 2022 Aug 3;2022:2274934. doi: 10.1155/2022/2274934. eCollection 2022.
PubMed 35966574
Ye X, Ren YF, Hu YC, Tan SY, Jiang H, Zhang LF, Shi W, Wang YT. Dexamethasone Does Not Provide Additional Clinical Analgesia Effect to Local Wound Infiltration: A Comprehensive Systematic Review and Meta-Analysis. Adv Wound Care (New Rochelle). 2023 Jan;12(1):1-14. doi: 10.1089/wound.2021.0163. Epub 2022 Mar 1.
PubMed 35081741
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
Han X, Ren T, Wang Y, Ji N, Luo F. Postoperative Analgesic Efficacy and Safety of Ropivacaine Plus Diprospan for Preemptive Scalp Infiltration in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Trial. Anesth Analg. 2022 Dec 1;135(6):1253-1261. doi: 10.1213/ANE.0000000000005971. Epub 2022 Mar 21.
PubMed 35313321
Yu B, Wang B, Shrestha N, Luo F. Pre-emptive coinfiltration of dexamethasone palmitate emulsion with ropivacaine for postoperative pain in patients undergoing major spine surgery: a study protocol for a prospective, randomised controlled, multicentre trial. BMJ Open. 2023 May 24;13(5):e072162. doi: 10.1136/bmjopen-2023-072162.
PubMed 37225277

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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preemptive Co-infiltration of Dexamethasone Palmitate Emulsion With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery
ClinicalTrials.gov ID: NCT05693467
Acronym / sponsor ID: KY-2019-112-02-3
Conditions: Pain, Postoperative
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Beijing Tiantan HospitalUniversity, hospital or other
Study start: 1 Mar 2023 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 23 Jan 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 dexamethasone palmitate emulsion(DXP) plus ropivacaine group	Experimental	Drug: Dexamethasone palmitate emulsion(DXP) plus ropivacaineThe local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of dexamethasone palmitate emulsion(DXP) and ropivacaine.
The ropivacaine alone group	Active comparator	Drug: Ropivacaine aloneThe local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone.

Who may qualify

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

Key inclusion criteria (4 listed)

Age 18-64 years;
Patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia
American Society of Anesthesiologists (ASA) physical status of I-III;
Anticipated full recovery and cooperation within 2 hours postoperatively.

Key exclusion criteria (14 listed)

History of spinal surgery;
Inability to use a patient-controlled analgesia (PCA) pump or comprehend the pain visual analog scale (VAS);
Body mass index (BMI)<15kg/m2 or >35kg/m2;
Peri-incisional infection;
History of diabetes mellitus and other metabolic diseases;

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
Dexamethasone palmitate emulsion(DXP) plus ropivacaineAlso: DXP plus ropivacaineThe local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of ropivacaine and dexamethasone palmitate emulsion(DXP). For local infiltration, a total of 30mL solution will be prepared for each group, which will include 2mL of DXP(4mg per 1mL) added to 20.5 mL of saline and 7.5mL of 1% ropivacaine added to 15mL of saline for Group A . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.	Drug	The dexamethasone palmitate emulsion(DXP) plus ropivacaine group
Ropivacaine aloneThe local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone. For local infiltration, a total of 30mL solution will be prepared for each group, which will include 7.5mL of ropivacaine added to 22.5mL of saline for Group B . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.	Drug	The ropivacaine alone group

Primary outcome

The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump.
Time frame: Within 24 hours after spinal surgery
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) pump. Participates will be advised to push the analgesic demand button if they feel pain.

17 secondary outcomes

The cumulative consumption of sufentanil via PCA pump between 24 hours and 48 hours postoperatively.
Time frame: Between 24 hours and 48 hours after spinal surgery
Number of patients without PCA press button
Time frame: Within 48 hours after spinal surgery
The time of first PCA demand
Time frame: Within 48 hours after spinal surgery
The total number of PCA presses including both valid and invalid presses
Time frame: Within 48 hours after spinal surgery
Postoperative visual analogue scale (VAS) score during movement(VASm)
Time frame: At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively
Postoperative VAS score at rest(VASr)
Time frame: At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively
Total consumption of Tylenol as supplementary analgesia
Time frame: Four separate postoperative periods ( 0- postoperative 48 hours, postoperative 48 hours-postoperative 2 weeks, postoperative 2 weeks-postoperative 1 month, and postoperative 1 month-postoperative 3 months)
Patient Satisfaction Score (PSS) with pain relief
Time frame: At 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks 1 month and 3 months postoperatively
Postoperative nausea and vomiting (PONV) score
Time frame: At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively
Ramsay Sedation Scale (RSS)
Time frame: At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively
Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)
Time frame: At 2 weeks, 1 month and 3 months postoperatively
Rate of steroid-related side effects and complications
Time frame: Through the whole follow-up, an average of 3 months
Readmission rate within 3 months after spine surgery;
Time frame: Through the whole follow-up, within 3 months after spine surgery
Length of Postoperative Anesthesia Care Unit (PACU) stay
Time frame: Approximately 30 minutes to 2 hours after surgery
Duration of hospitalization after surgery
Time frame: Approximately 1-2 weeks after surgery
Total consumption of remifentanil during surgery
Time frame: During surgery
Total consumption of loxoprofen
Time frame: From postoperative 48 hours to approximately 1-2 weeks 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 16 Apr 2024.
Background: PubMed 28731875Lamperti M, Tufegdzic B, Avitsian R. Management of complex spine surgery. Curr Opin Anaesthesiol. 2017 Oct;30(5):551-556. doi: 10.1097/ACO.0000000000000494.
Background: PubMed 22260370Kjaergaard M, Moiniche S, Olsen KS. Wound infiltration with local anesthetics for post-operative pain relief in lumbar spine surgery: a systematic review. Acta Anaesthesiol Scand. 2012 Mar;56(3):282-90. doi: 10.1111/j.1399-6576.2011.02629.x. Epub 2012 Jan 19.
Background: PubMed 32474417Bai JW, An D, Perlas A, Chan V. Adjuncts to local anesthetic wound infiltration for postoperative analgesia: a systematic review. Reg Anesth Pain Med. 2020 Aug;45(8):645-655. doi: 10.1136/rapm-2020-101593. Epub 2020 May 30.
Background: PubMed 35966574Shrestha N, Han B, Wang X, Jia W, Luo F. Methylprednisolone as an Adjunct to Local Infiltration on Laminoplasty or Laminectomy before Wound Closure: A Randomized Controlled Trial. Pain Res Manag. 2022 Aug 3;2022:2274934. doi: 10.1155/2022/2274934. eCollection 2022.
Background: PubMed 35081741Ye X, Ren YF, Hu YC, Tan SY, Jiang H, Zhang LF, Shi W, Wang YT. Dexamethasone Does Not Provide Additional Clinical Analgesia Effect to Local Wound Infiltration: A Comprehensive Systematic Review and Meta-Analysis. Adv Wound Care (New Rochelle). 2023 Jan;12(1):1-14. doi: 10.1089/wound.2021.0163. Epub 2022 Mar 1.
Background: 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.
Background: PubMed 35313321Han X, Ren T, Wang Y, Ji N, Luo F. Postoperative Analgesic Efficacy and Safety of Ropivacaine Plus Diprospan for Preemptive Scalp Infiltration in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Trial. Anesth Analg. 2022 Dec 1;135(6):1253-1261. doi: 10.1213/ANE.0000000000005971. Epub 2022 Mar 21.
Derived from this study: PubMed 37225277Yu B, Wang B, Shrestha N, Luo F. Pre-emptive coinfiltration of dexamethasone palmitate emulsion with ropivacaine for postoperative pain in patients undergoing major spine surgery: a study protocol for a prospective, randomised controlled, multicentre trial. BMJ Open. 2023 May 24;13(5):e072162. doi: 10.1136/bmjopen-2023-072162.
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 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 Dexamethasone palmitate emulsion(DXP) plus ropivacaine and Ropivacaine alone 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 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 16 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?

The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump. (time frame: Within 24 hours after spinal surgery). 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 NCT05693467, which also lists 8 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 16 Apr 2024.