LaminectomyPhase 3NCT07429708
Dexamethasone as ESPB Adjuvant in Lumbar Laminectomy
A Phase 3 study testing Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mg and Bilateral ESPB: Ropivacaine 0.375% in people with Laminectomy and Postperative Pain Management, run by Udayana University at 1 site in Indonesia.
Trial summary
Laminectomy is a routine procedure for patients with lumbar spinal stenosis, offering significant benefits such as reduced low back pain, alleviation of radiculopathy, and improved motor strength 1 23. Despite these advantages, postoperative pain remains a challenge for anesthesiologists. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laminectomy, Postperative Pain Management, Prostaglandin E2
- What is being tested?
- Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mg and Bilateral ESPB: Ropivacaine 0.375%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Mar 2025to 1 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 - 65 years
- ASA physical status I-III
- Patients with a BMI of 18 - 30 kg/m2
Who cannot join
- Patients with contraindications to regional anesthesia
- Infection at the puncture site
- Type 2 Diabetes Mellitus (T2DM)
- Hypersensitivity or allergy to the medications used
- Prolonged or chronic opioid use
- Laminectomy involving more than two segments
- Inability to be assessed using the Visual Analogue Scale (VAS) or to operate the PCA device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dexamethasone as an Adjuvant to Bilateral Erector Spinae Plane Block for Lumbar Laminectomy: A Randomized Controlled Trial
Laminectomy is a routine procedure for patients with lumbar spinal stenosis, offering significant benefits such as reduced low back pain, alleviation of radiculopathy, and improved motor strength 1 23. Despite these advantages, postoperative pain remains a challenge for anesthesiologists. According to Davin et al., approximately 80% of patients undergoing lumbar laminectomy experience postoperative discomfort, with 20% developing persistent postsurgical pain (PPSP). The application of erector spinae plane (ESP) block in lumbar laminectomy surgery significantly reduces postoperative pain and hospital length of stay. However, ESP block without adjuvants has limitations in duration. Adjuvants are thus required to optimize the effects of ESP block 4.
Dexamethasone is a glucocorticoid that is widely used in the perioperative setting. Interfascial administration of dexamethasone has been shown to prolong the duration of analgesia provided by the peripheral nerve blocks. Pehora et al (2017) reported that perineural dexamethasone with local anesthetics prolongs sensory blockade, effectively reducing postoperative pain intensity and opioid consumption. Its analgesic effects likely stem from anti-inflammatory mechanisms, including supression of proinflammatory cytokines, induction of anti-inflammatory cytokines, reduced prostaglandin synthesis, and decreased neuronal excitability 5 6. Adjuvant dexamethasone provides additional benefits, including prolonged analgesia, reduced pain scores, lower postoperative opioid requirements, and decreased inflammation in patients undergoing lumbar laminectomy.
Prior literature has not examined the benefits of dexamethasone as an adjuvant for lumbar ESP block, nor measured and compared inflammatory biomarkers with its use. Therefore, this study investigates the efficacy of dexamethasone adjuant in ESP block for lumbar laminectomy surgery by assessing postoperative prostaglandin E2 levels, analgesia duration, pain scores (VAS) at 8, 12, 16, and 24 hours postoperatively, and patient-controlled analgesia (PCA) fentanyl requirements at the same intervals.
Read the detailed description
This study is a single-center, double-blind randomized controlled trial conducted in the Central Surgical Installation operating room at Ngoerah General Hospital, Denpasar, Indonesia, from March to August 2025, following ethical approval (No. 0326/UN14.2.2.VII.14/LT/2025). Participants were patients undergoing lumbar laminectomy during the study period. Consecutive sampling was employed. Inclusion criteria were age 18-65 years, American Society of Anesthesiologists (ASA) physical status I-III, and body mass index (BMI) 18-30 kg/m2. Exclusion criteria included contraindications to regional anesthesia, puncture site infection, type 2 diabetes mellitus, drug allergy, chronic opioid use, laminectomy involving >2 segments, or inability to assess Visual Analog Scale (VAS) pain or inability to use paient-controlled analgesia (PCA). Dropout criteria were hypotension >30% from baseline requiring continuous vasopressors or postoperative mechanical ventilation.
Sample size calculation determined 36 participants, randomized 1:1 into two groups using computer-generated simple randomization: Group P1 (n=18) received erector spinae plane (ESP) block with dexamethasone adjuvant, and Group P2 (n=18) received ESP block without dexamethasone. The study flowchart is shown in Figure 1.
All participants provided written informed consent. Upon arrival in the operating room, blood samples were collected for baseline prostaglandin E2 measurement. General anesthesia was induced with standard monitoring (SpO2, ECG, respiratory rate, noninvasive blood pressure) using propofol (2-3 mg/kg), fentanyl (1-2 mcg/kg), and rocuronium (0.6 mg/kg). Patients were then positioned prone for ESP block. Group P1 received 20 mL of 0.375% ropivacaine with 5 mg dexamethasone per side; Group P2 received 20 mL of 0.375% ropivacaine per side.
Anesthesia was maintained with sevoflurane, adjusted to achieve a minimum alveolar concentration of 1.2. Intraoperative analgesia included Paracetamol 1 g. Ondansetron 8 mg was administered for postoperative nausea and vomiting prophylaxis. Postoperative analgesia consisted of fentanyl PCA, oral paracetamol 500 mg every 6 hours, and oral ibuprofen 400 mg every 8 hours. Postoperative assessments were performed by the Acute Pain Service team, with blood sampling for Prostaglanin E2 at 24 hours postoperatively.
Primary outcome were postoperative prostaglandin E2 levels, analgesia duration, VAS pain score at 8, 12, 16, and 24 hours postoperatively, and fentanyl PCA requirements at the same intervals.
Descriptive data are presented as mean ± standard deviation. Normality was assessed using the Shapiro-Wilk test. Between-group comparisons used the independent t-test for normally distributed data or Mann-Whitney U test for non-normal data. Clinical interpretability was evaluated using 95% CI of the Difference. Analyses were performed using IBM SPSS Statistics for Windows, version 20.0 (IBM Corp., Armonk, NY, USA).
- Being tested
- Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mg, Bilateral ESPB: Ropivacaine 0.375%
- Keywords
- Dexamethasone, Erector Spinae Plane Block, Laminectomy, Prostaglandin E2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mgDrug
Initial identification is performed using ultrasound (USG) guidance. Once the erector spinae muscle and the transverse process are clearly visualized, local anesthetic infiltration is administered using 1-2 ml of 2% lidocaine. A Stimuplex needle is then inserted in a cranio-caudal direction deep into the erector spinae muscle using an in-plane approach until it makes contact with the lateral edge of the transverse process, which serves as the midpoint of the surgical area. For the intervention, a regimen of 0.375% ropivacaine combined with 5 mg of dexamethasone is administered in a volume of 20 ml on each side (bilateral), ensuring a dome-shaped distribution is visible both cranially and caudally beneath the erector spinae muscle.
Bilateral ESPB: Ropivacaine 0.375%Drug
Initial identification is performed using ultrasound (USG) guidance. Once the erector spinae muscle and the transverse process are clearly visualized, local anesthetic infiltration is administered with 1-2 ml of 2% lidocaine. A Stimuplex needle is then inserted in a cranio-caudal direction deep into the erector spinae muscle using an in-plane approach, making contact with the lateral edge of the transverse process, which serves as the midpoint of the surgical area. A regimen of 0.375% ropivacaine in a volume of 20 ml is administered on each side (bilateral) until a dome-shaped drug distribution is visualized cranially and caudally beneath the erector spinae muscle
| Study group | Role | What they receive |
|---|---|---|
| ESPB With Dexamethasone | Experimental | The dexamethasone-ESPB group receives a bilateral Erector Spinae Plane Block with a regimen consisting of 0.375% ropivacaine and 5 mg of dexamethasone, administered in a total volume of 20 ml on each side (right and left) of the back
The intervention is : Erector Spinae Plane Block Receives: Drug: Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mg |
| ESPB Without Dexamethasone | Active comparator | The non-dexamethasone ESPB group receives a bilateral Erector Spinae Plane Block with a regimen consisting of 0.375% ropivacaine, administered in a total volume of 20 ml on each side (right and left) of the back
The intervention is : Erector Spinae Plane Block Receives: Drug: Bilateral ESPB: Ropivacaine 0.375% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia
This represents the duration of analgesia, defined as the time from the administration of the Erector Spinae Plane (ESP) block until the patient first presses the Patient-Controlled Analgesia (PCA) fentanyl button. The data is presented in minutes.
Measured: From the completion of the ESP block until the first request for rescue analgesia (assessed up to 24 hours post-surgery)
Postoperative increase in PGE2 levels
The mean baseline prostaglandin E2 (PGE2) level was significantly lower in the dexamethasone group than in the non-adjuvant group (9.36 ± 2.57 vs 12.72 ± 4.35 ng/L; p = 0.008). The median postoperative increase in PGE2 was also significantly smaller in the dexamethasone group compared with the control group (7.03 [IQR 13.79] vs 19.05 [IQR 34.56]; p = 0.016)
Measured: PGE2 Levels Preoperatively (baseline) and 24 hours after surgery
Postoperative VAS pain scores at 8, 12, 16, and 24 hours
Postoperative Visual Analogue Scale (VAS) is a pain assessment score widely used in research and clinical practice to evaluate the intensity of subjective experiences, such as pain or discomfort, consisting of a 100 mm line with descriptive anchors. Assessments were performed at 8, 12, 16, and 24 hours postoperatively. Numerical variables are presented as mean and standard deviation (SD) for normally distributed data, or as median and interquartile range (IQR) for non-normally distributed data.
Measured: 8, 12, 16, and 24 hours after the surgery done
Postoperative PCA Fentanyl requirements
Postoperative fentanyl PCA requirements. These represent the postoperative fentanyl requirements at 8, 12, 16, and 24 hours, as recorded by the Patient-Controlled Analgesia (PCA) pump, starting from the Post-Anesthesia Care Unit (PACU) up to 24 hours postoperatively. Numerical variables are presented as mean and standard deviation (SD) for normally distributed data, or as median and interquartile range (IQR) for non-normally distributed data
Measured: 8, 12, 16, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start10 Mar 2025
- Primary completion25 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LaminectomyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study evaluates the effectiveness of adding dexamethasone as an adjuvant to the Bilateral Erector Spinae Plane (ESP) block for patients undergoing lumbar laminectomy surgery. While the ESP block is a common method for pain relief, its duration is often limited when used alone. The researchers aim to determine if dexamethasone can prolong the duration of pain relief, improve the overall quality of analgesia, and reduce the body's inflammatory response by measuring Prostaglandin E2 (PGE2) levels. Additionally, the study investigates whether this combination reduces the amount of opioid medication (fentanyl) required by patients during the first 24 hours after surgery. Thirty-six patients were randomly assigned to receive the ESP block either with or without dexamethasone to compare these outcomes
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albertus Medianto Walujo, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429708
- Sponsor's protocol ID
- 0326/UN14.2.2.VII.14/LT/2025
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The informed consent signed by participants does not include permission for the sharing of individual-level data with third parties. Protecting participant anonymity is our primary priority
Publications
Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.
PubMed 16236742Bravo D, Aliste J, Layera S, Fernandez D, Leurcharusmee P, Samerchua A, Tangjitbampenbun A, Watanitanon A, Arnuntasupakul V, Tunprasit C, Gordon A, Finlayson RJ, Tran DQ. A multicenter, randomized comparison between 2, 5, and 8 mg of perineural dexamethasone for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jan;44(1):46-51. doi: 10.1136/rapm-2018-000032.
PubMed 30640652
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexamethasone as an Adjuvant to Bilateral Erector Spinae Plane Block for Lumbar Laminectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07429708
- Acronym / sponsor ID
- 0326/UN14.2.2.VII.14/LT/2025
- Keywords
- Dexamethasone, Erector Spinae Plane Block, Laminectomy, Prostaglandin E2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 24 Feb 2026 (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.
Laminectomy is a routine procedure for patients with lumbar spinal stenosis, offering significant benefits such as reduced low back pain, alleviation of radiculopathy, and improved motor strength 1 23. Despite these advantages, postoperative pain remains a challenge for anesthesiologists. According to Davin et al., approximately 80% of patients undergoing lumbar laminectomy experience postoperative discomfort, with 20% developing persistent postsurgical pain (PPSP). The application of erector spinae plane (ESP) block in lumbar laminectomy surgery significantly reduces postoperative pain and hospital length of stay. However, ESP block without adjuvants has limitations in duration. Adjuvants are thus required to optimize the effects of ESP block 4.
Dexamethasone is a glucocorticoid that is widely used in the perioperative setting. Interfascial administration of dexamethasone has been shown to prolong the duration of analgesia provided by the peripheral nerve blocks. Pehora et al (2017) reported that perineural dexamethasone with local anesthetics prolongs sensory blockade, effectively reducing postoperative pain intensity and opioid consumption. Its analgesic effects likely stem from anti-inflammatory mechanisms, including supression of proinflammatory cytokines, induction of anti-inflammatory cytokines, reduced prostaglandin synthesis, and decreased neuronal excitability 5 6. Adjuvant dexamethasone provides additional benefits, including prolonged analgesia, reduced pain scores, lower postoperative opioid requirements, and decreased inflammation in patients undergoing lumbar laminectomy.
Prior literature has not examined the benefits of dexamethasone as an adjuvant for lumbar ESP block, nor measured and compared inflammatory biomarkers with its use. Therefore, this study investigates the efficacy of dexamethasone adjuant in ESP block for lumbar laminectomy surgery by assessing postoperative prostaglandin E2 levels, analgesia duration, pain scores (VAS) at 8, 12, 16, and 24 hours postoperatively, and patient-controlled analgesia (PCA) fentanyl requirements at the same intervals.
Detailed description
This study is a single-center, double-blind randomized controlled trial conducted in the Central Surgical Installation operating room at Ngoerah General Hospital, Denpasar, Indonesia, from March to August 2025, following ethical approval (No. 0326/UN14.2.2.VII.14/LT/2025). Participants were patients undergoing lumbar laminectomy during the study period. Consecutive sampling was employed. Inclusion criteria were age 18-65 years, American Society of Anesthesiologists (ASA) physical status I-III, and body mass index (BMI) 18-30 kg/m2. Exclusion criteria included contraindications to regional anesthesia, puncture site infection, type 2 diabetes mellitus, drug allergy, chronic opioid use, laminectomy involving >2 segments, or inability to assess Visual Analog Scale (VAS) pain or inability to use paient-controlled analgesia (PCA). Dropout criteria were hypotension >30% from baseline requiring continuous vasopressors or postoperative mechanical ventilation.
Sample size calculation determined 36 participants, randomized 1:1 into two groups using computer-generated simple randomization: Group P1 (n=18) received erector spinae plane (ESP) block with dexamethasone adjuvant, and Group P2 (n=18) received ESP block without dexamethasone. The study flowchart is shown in Figure 1.
All participants provided written informed consent. Upon arrival in the operating room, blood samples were collected for baseline prostaglandin E2 measurement. General anesthesia was induced with standard monitoring (SpO2, ECG, respiratory rate, noninvasive blood pressure) using propofol (2-3 mg/kg), fentanyl (1-2 mcg/kg), and rocuronium (0.6 mg/kg). Patients were then positioned prone for ESP block. Group P1 received 20 mL of 0.375% ropivacaine with 5 mg dexamethasone per side; Group P2 received 20 mL of 0.375% ropivacaine per side.
Anesthesia was maintained with sevoflurane, adjusted to achieve a minimum alveolar concentration of 1.2. Intraoperative analgesia included Paracetamol 1 g. Ondansetron 8 mg was administered for postoperative nausea and vomiting prophylaxis. Postoperative analgesia consisted of fentanyl PCA, oral paracetamol 500 mg every 6 hours, and oral ibuprofen 400 mg every 8 hours. Postoperative assessments were performed by the Acute Pain Service team, with blood sampling for Prostaglanin E2 at 24 hours postoperatively.
Primary outcome were postoperative prostaglandin E2 levels, analgesia duration, VAS pain score at 8, 12, 16, and 24 hours postoperatively, and fentanyl PCA requirements at the same intervals.
Descriptive data are presented as mean ± standard deviation. Normality was assessed using the Shapiro-Wilk test. Between-group comparisons used the independent t-test for normally distributed data or Mann-Whitney U test for non-normal data. Clinical interpretability was evaluated using 95% CI of the Difference. Analyses were performed using IBM SPSS Statistics for Windows, version 20.0 (IBM Corp., Armonk, NY, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study evaluates the effectiveness of adding dexamethasone as an adjuvant to the Bilateral Erector Spinae Plane (ESP) block for patients undergoing lumbar laminectomy surgery. While the ESP block is a common method for pain relief, its duration is often limited when used alone. The researchers aim to determine if dexamethasone can prolong the duration of pain relief, improve the overall quality of analgesia, and reduce the body's inflammatory response by measuring Prostaglandin E2 (PGE2) levels. Additionally, the study investigates whether this combination reduces the amount of opioid medication (fentanyl) required by patients during the first 24 hours after surgery. Thirty-six patients were randomly assigned to receive the ESP block either with or without dexamethasone to compare these outcomes
| Arm | Type | Receives |
|---|---|---|
| ESPB With Dexamethasone | Experimental | Drug: Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mgThe dexamethasone-ESPB group receives a bilateral Erector Spinae Plane Block with a regimen consisting of 0.375% ropivacaine and 5 mg of dexamethasone, administered in a total volume of 20 ml on each side (right and left) of the back The intervention is : Erector Spinae Plane Block |
| ESPB Without Dexamethasone | Active comparator | Drug: Bilateral ESPB: Ropivacaine 0.375%The non-dexamethasone ESPB group receives a bilateral Erector Spinae Plane Block with a regimen consisting of 0.375% ropivacaine, administered in a total volume of 20 ml on each side (right and left) of the back The intervention is : Erector Spinae Plane Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 - 65 years
- ASA physical status I-III
- Patients with a BMI of 18 - 30 kg/m2
Key exclusion criteria (7 listed)
- Patients with contraindications to regional anesthesia
- Infection at the puncture site
- Type 2 Diabetes Mellitus (T2DM)
- Hypersensitivity or allergy to the medications used
- Prolonged or chronic opioid use
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 |
|---|---|---|
| Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mgInitial identification is performed using ultrasound (USG) guidance. Once the erector spinae muscle and the transverse process are clearly visualized, local anesthetic infiltration is administered using 1-2 ml of 2% lidocaine. A Stimuplex needle is then inserted in a cranio-caudal direction deep into the erector spinae muscle using an in-plane approach until it makes contact with the lateral edge of the transverse process, which serves as the midpoint of the surgical area. For the intervention, a regimen of 0.375% ropivacaine combined with 5 mg of dexamethasone is administered in a volume of 20 ml on each side (bilateral), ensuring a dome-shaped distribution is visible both cranially and caudally beneath the erector spinae muscle. | Drug | ESPB With Dexamethasone |
| Bilateral ESPB: Ropivacaine 0.375%Initial identification is performed using ultrasound (USG) guidance. Once the erector spinae muscle and the transverse process are clearly visualized, local anesthetic infiltration is administered with 1-2 ml of 2% lidocaine. A Stimuplex needle is then inserted in a cranio-caudal direction deep into the erector spinae muscle using an in-plane approach, making contact with the lateral edge of the transverse process, which serves as the midpoint of the surgical area. A regimen of 0.375% ropivacaine in a volume of 20 ml is administered on each side (bilateral) until a dome-shaped drug distribution is visualized cranially and caudally beneath the erector spinae muscle | Drug | ESPB Without Dexamethasone |
Primary outcome
Duration of Analgesia
Time frame: From the completion of the ESP block until the first request for rescue analgesia (assessed up to 24 hours post-surgery)
This represents the duration of analgesia, defined as the time from the administration of the Erector Spinae Plane (ESP) block until the patient first presses the Patient-Controlled Analgesia (PCA) fentanyl button. The data is presented in minutes.
Postoperative increase in PGE2 levels
Time frame: PGE2 Levels Preoperatively (baseline) and 24 hours after surgery
The mean baseline prostaglandin E2 (PGE2) level was significantly lower in the dexamethasone group than in the non-adjuvant group (9.36 ± 2.57 vs 12.72 ± 4.35 ng/L; p = 0.008). The median postoperative increase in PGE2 was also significantly smaller in the dexamethasone group compared with the control group (7.03 [IQR 13.79] vs 19.05 [IQR 34.56]; p = 0.016)
Postoperative VAS pain scores at 8, 12, 16, and 24 hours
Time frame: 8, 12, 16, and 24 hours after the surgery done
Postoperative Visual Analogue Scale (VAS) is a pain assessment score widely used in research and clinical practice to evaluate the intensity of subjective experiences, such as pain or discomfort, consisting of a 100 mm line with descriptive anchors. Assessments were performed at 8, 12, 16, and 24 hours postoperatively. Numerical variables are presented as mean and standard deviation (SD) for normally distributed data, or as median and interquartile range (IQR) for non-normally distributed data.
Postoperative PCA Fentanyl requirements
Time frame: 8, 12, 16, and 24 hours after surgery
Postoperative fentanyl PCA requirements. These represent the postoperative fentanyl requirements at 8, 12, 16, and 24 hours, as recorded by the Patient-Controlled Analgesia (PCA) pump, starting from the Post-Anesthesia Care Unit (PACU) up to 24 hours postoperatively. Numerical variables are presented as mean and standard deviation (SD) for normally distributed data, or as median and interquartile range (IQR) for non-normally distributed data
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 24 Feb 2026.
- Results publication: PubMed 16236742Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.
- Results publication: PubMed 30640652Bravo D, Aliste J, Layera S, Fernandez D, Leurcharusmee P, Samerchua A, Tangjitbampenbun A, Watanitanon A, Arnuntasupakul V, Tunprasit C, Gordon A, Finlayson RJ, Tran DQ. A multicenter, randomized comparison between 2, 5, and 8 mg of perineural dexamethasone for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jan;44(1):46-51. doi: 10.1136/rapm-2018-000032.
- Individual participant dataSharing planned: No. The informed consent signed by participants does not include permission for the sharing of individual-level data with third parties. Protecting participant anonymity is our primary priority
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mg and Bilateral ESPB: Ropivacaine 0.375% in people with Laminectomy and Postperative Pain Management, run by Udayana University at 1 site in Indonesia.
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 7 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 24 Feb 2026. 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 Indonesia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Duration of Analgesia (time frame: From the completion of the ESP block until the first request for rescue analgesia (assessed up to 24 hours post-surgery)). The study lists 4 primary outcomes in all. 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 NCT07429708, which also lists 2 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 24 Feb 2026.