Chronic Pain Following Surgical Procedure for CancerNCT04700592
A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair
A study testing Gabapentin versus Ketamine in people with Chronic Pain Following Surgical Procedure for Cancer, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Patients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain Following Surgical Procedure for Cancer
- What is being tested?
- Gabapentin versus Ketamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Oct 2020to 2 Feb 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I and II
- Inguinal Hernia Repair in non emergent conditions
Who cannot join
- Patients with significant cardiovascular central nervous system disease, renal or liver failure could not operate the PCA device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair: a Prospective Randomized Study
Patients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg before induction of spinal anesthesia.. During the surgery, blood pressure and heart rate were monitored. Postoperative analgesia was provided by a PCA morphine. Acute postoperative pain was assessed by a visual analog scale. The incidence of postoperative neuropathic pain was detected by the DN4 questionnaire after one and three months of surgery.
Read the detailed description
the investigators includes patients aged at least 18 classified as ASA I and II. Patients with significant cardiovascular or central nervous system disease, as well as those with renal or liver failure and those who could not operate the PCA device were not eligible for our study.
Exclusion criteria were patients that had incidents during the surgery such as: an allergic reaction, local anesthetic systemic toxicity or a surgical incident.
Patients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg before induction of spinal anesthesia.
Upon arrival in the operating room, patients were monitored using mean blood pressure, heart rate and peripheral oxygen saturation monitors.
The surgery was performed under spinal anesthesia. Each patient received 10 mg of hyperbaric bupivacaine mixed with 5 µ of sufentanil.
Immediately after the intervention, the patients were transferred to the post anesthesia care unit (PACU) where analgesia was arranged through morphine titration.
After the motor block is lifted, patients were transferred to surgery department where they were connected to a PCA device that provided 1 mg IV bolus injection of morphine at a lockout interval of 7 minutes and with a maximum four-hour limit of 0.5 mg/Kg.
During the hospital stay, acute post-operative pain assessed through the visual analog scale (VAS) at rest and at motion, every 15 minutes in the PACU and then at H2, H6, H12 and H24 postoperative.
The morphine consumption was noted as well as its first demand. Sedation was assessed using the Ramsay score. The occurrence of adverse effects such as nausea and vomiting, dizziness, diarrhea, hallucination and pruritus was also noted.
The first night sleep quality was evaluated through the Spiegel score. After hospital discharge, patients were contacted at one month and three months. The incidence of post-operative neuropathic pain was detected by the DN4 questionnaire. The effect the pain had on their daily activities was also judged.
Statistical analysis:
According to available data (30% occurrence of post-operative chronic pain after inguinal hernia repair (2)), to decrease by 25% this number with a power of 80%, 28 patients were needed in each group.
Statistical analysis was performed with SPSS in its 20 version. Results were expressed as mean, standard variation or median. χ2 test, fisher's exact test and Mann-Whitney test were performed. A P value of < 0.05 was considered as statistically significant.
- Being tested
- Gabapentin versus Ketamine
- Keywords
- post operative chronic pain, gabapentin, ketamin, Inguinal Hernia Repair
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin versus KetamineOther
Also called acute and Chronic Pain
A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin group | Experimental | group which receives 600 mg of Gabapentin (two tablets) one hour prior to surgery Receives: Other: Gabapentin versus Ketamine |
| ketamine group | Experimental | group which receives an injection of ketamine at a dosage of 0.15 mg/Kg before surgery incision Receives: Other: Gabapentin versus Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative neuropathic pain
the DN4 questionnaire
Measured: three months of surgery
Secondary outcomes (2)
acute pain postoperative
the visual analogue scales (VAS) at rest and at motion
Measured: At twenty-four hour postoperative
Consumption of morphine
measuring consumption by PCA (PATIENT CONTROLLED ANALGESIA)
Measured: At 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start2 Oct 2020
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain Following Surgical Procedure for CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mechaal Benali, University Tunis El Manar
- Investigators
- mechaal benali, PROFESSOR, Principal investigator, university manar Tunis tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700592
- Sponsor's protocol ID
- UTEM GABA
- Status last verified
- May 2021
- First submitted
- 2 Jan 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- 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 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04700592
- Acronym / sponsor ID
- UTEM GABA
- Keywords
- post operative chronic pain, gabapentin, ketamin, Inguinal Hernia Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 8 Jan 2021 (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.
Patients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg before induction of spinal anesthesia.. During the surgery, blood pressure and heart rate were monitored. Postoperative analgesia was provided by a PCA morphine. Acute postoperative pain was assessed by a visual analog scale. The incidence of postoperative neuropathic pain was detected by the DN4 questionnaire after one and three months of surgery.
Detailed description
the investigators includes patients aged at least 18 classified as ASA I and II. Patients with significant cardiovascular or central nervous system disease, as well as those with renal or liver failure and those who could not operate the PCA device were not eligible for our study.
Exclusion criteria were patients that had incidents during the surgery such as: an allergic reaction, local anesthetic systemic toxicity or a surgical incident.
Patients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg before induction of spinal anesthesia.
Upon arrival in the operating room, patients were monitored using mean blood pressure, heart rate and peripheral oxygen saturation monitors.
The surgery was performed under spinal anesthesia. Each patient received 10 mg of hyperbaric bupivacaine mixed with 5 µ of sufentanil.
Immediately after the intervention, the patients were transferred to the post anesthesia care unit (PACU) where analgesia was arranged through morphine titration.
After the motor block is lifted, patients were transferred to surgery department where they were connected to a PCA device that provided 1 mg IV bolus injection of morphine at a lockout interval of 7 minutes and with a maximum four-hour limit of 0.5 mg/Kg.
During the hospital stay, acute post-operative pain assessed through the visual analog scale (VAS) at rest and at motion, every 15 minutes in the PACU and then at H2, H6, H12 and H24 postoperative.
The morphine consumption was noted as well as its first demand. Sedation was assessed using the Ramsay score. The occurrence of adverse effects such as nausea and vomiting, dizziness, diarrhea, hallucination and pruritus was also noted.
The first night sleep quality was evaluated through the Spiegel score. After hospital discharge, patients were contacted at one month and three months. The incidence of post-operative neuropathic pain was detected by the DN4 questionnaire. The effect the pain had on their daily activities was also judged.
Statistical analysis:
According to available data (30% occurrence of post-operative chronic pain after inguinal hernia repair (2)), to decrease by 25% this number with a power of 80%, 28 patients were needed in each group.
Statistical analysis was performed with SPSS in its 20 version. Results were expressed as mean, standard variation or median. χ2 test, fisher's exact test and Mann-Whitney test were performed. A P value of < 0.05 was considered as statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin group | Experimental | Other: Gabapentin versus Ketaminegroup which receives 600 mg of Gabapentin (two tablets) one hour prior to surgery |
| ketamine group | Experimental | Other: Gabapentin versus Ketaminegroup which receives an injection of ketamine at a dosage of 0.15 mg/Kg before surgery incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I and II
- Inguinal Hernia Repair in non emergent conditions
Key exclusion criteria (1 listed)
- Patients with significant cardiovascular central nervous system disease, renal or liver failure could not operate the PCA device
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 versus KetamineAlso: acute and Chronic PainA Comparison of Gabapentin and Ketamine in Acute and Chronic Pain | Other | Gabapentin group, ketamine group |
Primary outcome
postoperative neuropathic pain
Time frame: three months of surgery
the DN4 questionnaire
2 secondary outcomes
acute pain postoperative
Time frame: At twenty-four hour postoperative
Consumption of morphine
Time frame: At 24 hour postoperative
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 3 Jun 2021.
- Individual participant dataSharing planned: No
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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.
mechaal benali, PROFESSOR principal investigator
university manar Tunis tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin versus Ketamine in people with Chronic Pain Following Surgical Procedure for Cancer, run by University Tunis El Manar at 1 site in Tunisia.
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 2 inclusion and 1 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 3 Jun 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 Tunisia. 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.
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?
postoperative neuropathic pain (time frame: three months of surgery). 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 3 Jun 2021.