Non-obstetric Lower Abdominal SurgeryPhase 1/2NCT04434430
Preemptive Oral Gabapentin 600 mg in Reducing Morphine Requirement After Non Obstetric Lower Abdominal Surgery
A Phase 1/2 study testing Gabapentin in people with Non-obstetric Lower Abdominal Surgery, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aimed to get the information about the effectiveness of preemptive oral gabapentin 600 mg in reducing morphine requirement after non obstetric lower abdominal surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-obstetric Lower Abdominal Surgery
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Nov 2019to 29 Feb 2020
- Phase
- Phase 1/2
- 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
- Male or female
- Age: 18-65 years old
- Weigh in range around 20% of the ideal body weight
- Physical status ASA I-II
- Scheduled for elective non-obstetric lower abdominal surgery with general anesthesia
- Duration of surgery less than 4 hours
- Patients who agreed to participate in this study and sign informed consent
Who cannot join
- Patients who have history of allergy or hypersensitivity to gabapentin, paracetamol, morphine, or the other opioids
- Patients who consumed analgesia and NSAID less than 12 hours before surgery
- Patients who experienced physical trauma less than 4 days before surgery
- Patients who have contraindications to gabapentin, morphine, and paracetamol
- Patients who were treated with neuraxial block or peripheral nerve block before and during surgery
- Patients who have history of diabetes, severe live or renal disease
Show all 10Show fewer
- Patients who were treated with antihypertension, sedatives, hypnotics, antidepressants, and the other drugs that have effects on nervous system
- Patients who have psychiatric disorders
- Patients who consumed gabapentin before perioperative period
- Pregnant or breastfeeding patients
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Effectiveness of Preemptive Oral Gabapentin 600 mg on Morphine Requirement After Non Obstetric Lower Abdominal Surgery
This study aimed to get the information about the effectiveness of preemptive oral gabapentin 600 mg in reducing morphine requirement after non obstetric lower abdominal surgery
Read the detailed description
Seventy-two subjects were given informed consent before enrolling the study and randomized into two groups; gabapentin and placebo. Two hours before the incision, patients were given preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were extubated until fully conscious. Patients will be transported to recovery room postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement, interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine requirement, mean visual analogue scale, and time interval after surgery to the first administration of morphine will be assessed in this study.
- Conditions
- Non-obstetric Lower Abdominal Surgery
- Being tested
- Gabapentin, Placebo
- Keywords
- preemptive analgesia, gabapentin, morphine, lower abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Oral Gabapentin 600 mg
PlaceboOther
Oral NaCl 500 mg
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | Patient will receive preemptive oral gabapentin 600 mg Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Patient will receive oral placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery
Measured by total consumption of morphine on patient controlled analgesia machine
Measured: 24 hours after surgery
Pain within 24 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
Measured: 24 hours after surgery
Secondary outcomes (6)
Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
Measured: 2 hours after surgery
Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
Measured: 6 hours after surgery
Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
Measured: 12 hours after surgery
Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery
Measured by total consumption of morphine on patient controlled analgesia machine
Measured: 2 hours after surgery
Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery
Measured by total consumption of morphine on patient controlled analgesia machine
Measured: 6 hours after surgery
Cumulative morphine requirement within 12 hours after non obstetric lower abdominal surgery
Measured by total consumption of morphine on patient controlled analgesia machine
Measured: 12 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 posted16 Jun 2020
- Study start11 Nov 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non-obstetric Lower Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andi Ade Wijaya Ramlan, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434430
- Sponsor's protocol ID
- IndonesiaUAnes 054
- Status last verified
- Sep 2021
- First submitted
- 29 May 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
PubMed 18582931Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
PubMed 26526062Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
PubMed 19672167Shavit Y, Fridel K, Beilin B. Postoperative pain management and proinflammatory cytokines: animal and human studies. J Neuroimmune Pharmacol. 2006 Dec;1(4):443-51. doi: 10.1007/s11481-006-9043-1. Epub 2006 Sep 29.
PubMed 18040817Beilin B, Shavit Y, Trabekin E, Mordashev B, Mayburd E, Zeidel A, Bessler H. The effects of postoperative pain management on immune response to surgery. Anesth Analg. 2003 Sep;97(3):822-827. doi: 10.1213/01.ANE.0000078586.82810.3B.
PubMed 12933409Lee BH, Park JO, Suk KS, Kim TH, Lee HM, Park MS, Lee SH, Park S, Lee JY, Ko SK, Moon SH. Pre-emptive and multi-modal perioperative pain management may improve quality of life in patients undergoing spinal surgery. Pain Physician. 2013 May-Jun;16(3):E217-26.
PubMed 23703420
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Preemptive Oral Gabapentin 600 mg on Morphine Requirement After Non Obstetric Lower Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04434430
- Acronym / sponsor ID
- IndonesiaUAnes 054
- Conditions
- Non-obstetric Lower Abdominal Surgery
- Keywords
- preemptive analgesia, gabapentin, morphine, lower abdominal surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 16 Jun 2020 (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.
This study aimed to get the information about the effectiveness of preemptive oral gabapentin 600 mg in reducing morphine requirement after non obstetric lower abdominal surgery
Detailed description
Seventy-two subjects were given informed consent before enrolling the study and randomized into two groups; gabapentin and placebo. Two hours before the incision, patients were given preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were extubated until fully conscious. Patients will be transported to recovery room postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement, interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine requirement, mean visual analogue scale, and time interval after surgery to the first administration of morphine will be assessed in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: GabapentinPatient will receive preemptive oral gabapentin 600 mg |
| Placebo | Placebo comparator | Other: PlaceboPatient will receive oral placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- Age: 18-65 years old
- Weigh in range around 20% of the ideal body weight
- Physical status ASA I-II
- Scheduled for elective non-obstetric lower abdominal surgery with general anesthesia
Key exclusion criteria (10 listed)
- Patients who have history of allergy or hypersensitivity to gabapentin, paracetamol, morphine, or the other opioids
- Patients who consumed analgesia and NSAID less than 12 hours before surgery
- Patients who experienced physical trauma less than 4 days before surgery
- Patients who have contraindications to gabapentin, morphine, and paracetamol
- Patients who were treated with neuraxial block or peripheral nerve block before and during surgery
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 |
|---|---|---|
| GabapentinOral Gabapentin 600 mg | Drug | Gabapentin |
| PlaceboOral NaCl 500 mg | Other | Placebo |
Primary outcome
Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery
Time frame: 24 hours after surgery
Measured by total consumption of morphine on patient controlled analgesia machine
Pain within 24 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Time frame: 24 hours after surgery
Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences. The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
6 secondary outcomes
Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Time frame: 2 hours after surgery
Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Time frame: 6 hours after surgery
Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Time frame: 12 hours after surgery
Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery
Time frame: 2 hours after surgery
Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery
Time frame: 6 hours after surgery
Cumulative morphine requirement within 12 hours after non obstetric lower abdominal surgery
Time frame: 12 hours 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 13 Sep 2021.
- Results publication: PubMed 18582931Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
- Results publication: PubMed 26526062Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
- Results publication: PubMed 19672167Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
- Results publication: PubMed 18040817Shavit Y, Fridel K, Beilin B. Postoperative pain management and proinflammatory cytokines: animal and human studies. J Neuroimmune Pharmacol. 2006 Dec;1(4):443-51. doi: 10.1007/s11481-006-9043-1. Epub 2006 Sep 29.
- Results publication: PubMed 12933409Beilin B, Shavit Y, Trabekin E, Mordashev B, Mayburd E, Zeidel A, Bessler H. The effects of postoperative pain management on immune response to surgery. Anesth Analg. 2003 Sep;97(3):822-827. doi: 10.1213/01.ANE.0000078586.82810.3B.
- Results publication: PubMed 23703420Lee BH, Park JO, Suk KS, Kim TH, Lee HM, Park MS, Lee SH, Park S, Lee JY, Ko SK, Moon SH. Pre-emptive and multi-modal perioperative pain management may improve quality of life in patients undergoing spinal surgery. Pain Physician. 2013 May-Jun;16(3):E217-26.
- Individual participant dataSharing planned: No
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 1/2 study testing Gabapentin in people with Non-obstetric Lower Abdominal Surgery, run by Universitas Indonesia 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 7 inclusion and 10 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 13 Sep 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 morphine requirement within 24 hours after non obstetric lower abdominal surgery (time frame: 24 hours after surgery). The study lists 2 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 NCT04434430, which also lists 6 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 13 Sep 2021.