Prolongation of Spinal AnesthesiaEarly Phase 1NCT05659810
The Effect of Gabapentin on Spinal Anesthesia Duration
A Early Phase 1 study testing Gabapentin 300mg in people with Prolongation of Spinal Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective parallel group double blinded randomized study will be conducted over 60 adult participants between 20 and 60 years ASA (American Association of Anesthesiologists) I and II. The participants will be randomly allocated in 2 groups. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Prolongation of Spinal Anesthesia
- What is being tested?
- Gabapentin 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Dec 2022to 10 Apr 2023
- Phase
- Early Phase 1
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists class I, and II
- Age 20 - 60 years
- Weight between 60 and 80 kilograms
- Height between 160 and 180 centimetres
Who cannot join
- Participants with contraindications to spinal anesthesia.
- Participant refusal
- Extreme short or tall statures
- Body mass index above 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Gabapentin on the Duration of Spinal Anesthesia in Patients Undergoing Lower Limb Surgery: A Double-blind, Randomized Clinical Study
This prospective parallel group double blinded randomized study will be conducted over 60 adult participants between 20 and 60 years ASA (American Association of Anesthesiologists) I and II. The participants will be randomly allocated in 2 groups. Group A will receive 900 mg of gabapentin before surgery in 2 divided doses; 300 mg 10 hours prior to surgery and 600 mg 2 hours before surgery, while group B will receive 2 placebo tablets at the same time. The participants will receive spinal anesthesia in the form of 3ml of hyperbaric bupivacaine 0.5%. Hemodynamics will be recorded every 15 minutes till the end of surgery. Sensory, and motor block progression, and regression will be recorded also.
Read the detailed description
A prospective double blinded randomized trial to study the effect of gabapentin on the duration of spinal anesthesia. The participants will be divided into 2 groups. Group A will receive 900 mg of gabapentin before surgery in 2 divided doses; 300 mg 10 hours prior to surgery and 600 mg 2 hours before surgery, while group B will receive 2 placebo tablets at the same time.
The patient will be seated and after sterilization of his back with povidone iodine, a midline intrathecal injection of the 3ml of hyperbaric bupivacaine 0.5% at L 3/4 - L4/5 will be done via a 25G needle. Neural block will be assessed by using pin prick test, motor block will be assessed by using the modified Bromage scale, results will be recorded every 3 min until the level is stable for 3 consecutive tests.
After successful intrathecal injection, the patient will be monitored continuously for block progression and complications. The patient's blood pressure will be taken every 3 minutes initially, more frequently if needed. The patient will be monitored for the following:
Ensure that the block is adequate for the surgical procedure and it does not progress too high (motor block will be assessed by modified Bromage score and the sensory level by pin prick test up to T7-T10 level)
Sensory block will be assessed by pin prick test (Hollman test) using a 3-point scale; (0) = Normal sensation, (1) = Loss of sensation of pin prick (analgesia), and (2) = Loss of sensation of touch (anesthesia).
Onset time for sensory block will be defined as the time interval between the end of local anesthetic administration and complete sensory block (score 2 for all nerves). Duration of sensory block will be defined as the time interval between the complete sensory block and complete resolution of anesthesia (score 0 for all nerves).
Motor block is determined by using the modified Bromage scale (Bromage 0, the patient is able to move the hip, knee and ankle; Bromage 1 when the patient is unable to move the hip but is able to move the knee and ankle, Bromage 2 when the patient is unable to move the hip and knee but able to move the ankle, Bromage 3 when the patient is unable to move the hip, knee and ankle). The interval between the injection and block completion was considered as the onset of motor block. Duration of motor block will be defined as the time interval between the complete motor block and complete resolution of anesthesia. Failed block will be considered if the sensory block and motor block were not achieved after 20 min.
- Pain assessment: Patients will be followed every 2 hours postoperatively till 12 hours for analgesic requirements. Postoperative pain will be assessed via the Visual analogue scale (VAS), and when the VAS is more than 4 the patient will receive 0.25mg/kg nalbuphine.
- Conditions
- Prolongation of Spinal Anesthesia
- Being tested
- Gabapentin 300mg
- Keywords
- Gabapentin, Spinal, Anesthesia, Visual analogue scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 300mgDrug
Also called placebo tablet
Preoperative gabapentin before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Preoperative oral gabapentin before spinal anesthesia | Active comparator | The participants will receive 900 mg of gabapentin before surgery in 2 divided doses; 300 mg 10 hours prior to surgery and 600 mg 2 hours before surgery. Receives: Drug: Gabapentin 300mg |
| Preoperative oral placebo before spinal anesthesia | Placebo comparator | The participants will receive 1 tablet 10 hours prior to surgery, and then 2 tablets 2 hours prior to surgery Receives: Drug: Gabapentin 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the time of regression of sensory block
Measurement of the time of regression of sensory block by using pin prick test
Measured: 4 hours
Measurement of time of regression of motor block
Measurement of time of regression of motor block by using Bromage scale from 0-4
Measured: 4 hours
Secondary outcomes (2)
Measurement of time to onset of sensory block
Measurement of time to onset of sensory block by using pin prick test
Measured: 15 minutes
Measurement of duration of postoperative analgesia
Measurement of the duration of postoperative analgesia using the visual analogue scale from 0-10
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start26 Dec 2022
- Primary completion28 Mar 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolongation of Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization by concealed envelope method
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Refaat, Ain Shams University
- Investigators
- Ain Shams, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659810
- Sponsor's protocol ID
- R 177/2022
- Status last verified
- Apr 2023
- First submitted
- 23 Nov 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Gabapentin on the Duration of Spinal Anesthesia in Patients Undergoing Lower Limb Surgery: A Double-blind, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05659810
- Acronym / sponsor ID
- R 177/2022
- Conditions
- Prolongation of Spinal Anesthesia
- Keywords
- Gabapentin, Spinal, Anesthesia, Visual analogue scale
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 21 Dec 2022 (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 prospective parallel group double blinded randomized study will be conducted over 60 adult participants between 20 and 60 years ASA (American Association of Anesthesiologists) I and II. The participants will be randomly allocated in 2 groups. Group A will receive 900 mg of gabapentin before surgery in 2 divided doses; 300 mg 10 hours prior to surgery and 600 mg 2 hours before surgery, while group B will receive 2 placebo tablets at the same time. The participants will receive spinal anesthesia in the form of 3ml of hyperbaric bupivacaine 0.5%. Hemodynamics will be recorded every 15 minutes till the end of surgery. Sensory, and motor block progression, and regression will be recorded also.
Detailed description
A prospective double blinded randomized trial to study the effect of gabapentin on the duration of spinal anesthesia. The participants will be divided into 2 groups. Group A will receive 900 mg of gabapentin before surgery in 2 divided doses; 300 mg 10 hours prior to surgery and 600 mg 2 hours before surgery, while group B will receive 2 placebo tablets at the same time.
The patient will be seated and after sterilization of his back with povidone iodine, a midline intrathecal injection of the 3ml of hyperbaric bupivacaine 0.5% at L 3/4 - L4/5 will be done via a 25G needle. Neural block will be assessed by using pin prick test, motor block will be assessed by using the modified Bromage scale, results will be recorded every 3 min until the level is stable for 3 consecutive tests.
After successful intrathecal injection, the patient will be monitored continuously for block progression and complications. The patient's blood pressure will be taken every 3 minutes initially, more frequently if needed. The patient will be monitored for the following:
Ensure that the block is adequate for the surgical procedure and it does not progress too high (motor block will be assessed by modified Bromage score and the sensory level by pin prick test up to T7-T10 level)
Sensory block will be assessed by pin prick test (Hollman test) using a 3-point scale; (0) = Normal sensation, (1) = Loss of sensation of pin prick (analgesia), and (2) = Loss of sensation of touch (anesthesia).
Onset time for sensory block will be defined as the time interval between the end of local anesthetic administration and complete sensory block (score 2 for all nerves). Duration of sensory block will be defined as the time interval between the complete sensory block and complete resolution of anesthesia (score 0 for all nerves).
Motor block is determined by using the modified Bromage scale (Bromage 0, the patient is able to move the hip, knee and ankle; Bromage 1 when the patient is unable to move the hip but is able to move the knee and ankle, Bromage 2 when the patient is unable to move the hip and knee but able to move the ankle, Bromage 3 when the patient is unable to move the hip, knee and ankle). The interval between the injection and block completion was considered as the onset of motor block. Duration of motor block will be defined as the time interval between the complete motor block and complete resolution of anesthesia. Failed block will be considered if the sensory block and motor block were not achieved after 20 min.
- Pain assessment: Patients will be followed every 2 hours postoperatively till 12 hours for analgesic requirements. Postoperative pain will be assessed via the Visual analogue scale (VAS), and when the VAS is more than 4 the patient will receive 0.25mg/kg nalbuphine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization by concealed envelope method
| Arm | Type | Receives |
|---|---|---|
| Preoperative oral gabapentin before spinal anesthesia | Active comparator | Drug: Gabapentin 300mgThe participants will receive 900 mg of gabapentin before surgery in 2 divided doses; 300 mg 10 hours prior to surgery and 600 mg 2 hours before surgery. |
| Preoperative oral placebo before spinal anesthesia | Placebo comparator | Drug: Gabapentin 300mgThe participants will receive 1 tablet 10 hours prior to surgery, and then 2 tablets 2 hours prior to surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists class I, and II
- Age 20 - 60 years
- Weight between 60 and 80 kilograms
- Height between 160 and 180 centimetres
Key exclusion criteria (4 listed)
- Participants with contraindications to spinal anesthesia.
- Participant refusal
- Extreme short or tall statures
- Body mass index above 40
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 |
|---|---|---|
| Gabapentin 300mgAlso: placebo tabletPreoperative gabapentin before spinal anesthesia | Drug | Preoperative oral gabapentin before spinal anesthesia, Preoperative oral placebo before spinal anesthesia |
Primary outcome
Measurement of the time of regression of sensory block
Time frame: 4 hours
Measurement of the time of regression of sensory block by using pin prick test
Measurement of time of regression of motor block
Time frame: 4 hours
Measurement of time of regression of motor block by using Bromage scale from 0-4
2 secondary outcomes
Measurement of time to onset of sensory block
Time frame: 15 minutes
Measurement of duration of postoperative analgesia
Time frame: 12 hours
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 28 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Prolongation of Spinal Anesthesia
Not yet recruitingPhase 4
The Prolonging Effect of Dexmedetomidine on Spinal Anesthesia Through Different Routes if Administrations
Spinal Anesthesia Evaluation
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.
Ain Shams principal investigator
University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gabapentin 300mg in people with Prolongation of Spinal Anesthesia, run by Ain Shams University at 1 site in Egypt.
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 4 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 28 Apr 2023. 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 Egypt. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Measurement of the time of regression of sensory block (time frame: 4 hours). 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?
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 28 Apr 2023.