Pain, PostoperativePhase 4NCT03241875
Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy
A Phase 4 study testing Pregabalin 75mg and Gabapentin 300mg in people with Pain, Postoperative and Cholecystectomy, Laparoscopic, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
Trial summary
The aim of this study is to evaluate the effect of premedication with pregabalin or gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative, Cholecystectomy, Laparoscopic
- What is being tested?
- Pregabalin 75mg and Gabapentin 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Dec 2016to 28 Sep 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- uncomplicated laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) status < 3
Who cannot join
- acute cholecystitis
- conversion to open cholecystectomy
- history of epilepsia, psychiatric disorders and cognitive impairment
- Pregnancy and breastfeeding
- allergy to pregabalin and/or gabapentin
- Chronic pain
- Chronic medication by corticosteroids, neuroleptics or non steroidal anti inflammatory drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy. A Randomized Clinical Trial
The aim of this study is to evaluate the effect of premedication with pregabalin or gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.
Read the detailed description
Preoperative premedication with gabapentins reduces preoperative anxiety, stress response to surgical stimuli, decreases anesthetic use. The incidence of postoperative nausea and vomiting appears to be decreased. The other desired effect of gabapentins is the reduction in the intensity of postoperative pain after laparoscopic surgery.
- Conditions
- Pain, Postoperative, Cholecystectomy, Laparoscopic
- Being tested
- Pregabalin 75mg, Gabapentin 300mg, Placebo oral capsule
- Keywords
- pregabalin, gabapentin, post operative pain, laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 75mgDrug
In this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction.
Gabapentin 300mgDrug
In this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction.
Placebo oral capsuleDrug
Also called placebo
In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Patients receive 2 capsules as placebo 2 hours before anesthesia. The capsules are delivered by the hospital pharmacy. Receives: Drug: Placebo oral capsule |
| pregabalin | Experimental | patients receive 2 capsules of pregabalin (pregabalin 75), two hours before anesthesia. Receives: Drug: Pregabalin 75mg |
| gabapentin | Experimental | patients receive 2 capsules of gabapentin (gabapentin 300), two hours before anesthesia. Receives: Drug: Gabapentin 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative shoulder pain
Primary outcome is the intensity of shoulder pain during the first 48 hours after laparoscopic cholecystectomy using the visual analog scale (VAS).
Measured: VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery
Secondary outcomes (3)
remifentanil consumption during anesthesia
Remifentanil requirements during anesthesia were calculated (µg/kg/mn)
Measured: one hour after tracheal tube removal
Post operative sleep quality during the first night
Patient's sleep quality was assessed during the first postoperative night by the Spiegel score.
Measured: first night after surgery
Post operative nausea and vomiting
The intensity of post operative nausea and vomiting was assessed by a 0 to 3 score (0: no nausea or vomiting, 1: slight mild nausea, 2: moderate nausea, 3: vomiting).
Measured: 2, 6, 12, 24 and 48 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 posted8 Aug 2017
- Study start1 Dec 2016
- Primary completion30 Aug 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Said NAKHLI, Faculty of Medicine, Sousse
- Investigators
- Mohamed Said Nakhli, MD, Principal investigator, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241875
- Sponsor's protocol ID
- Nakhli anesthesia sahloul
- Status last verified
- Sep 2017
- First submitted
- 29 Jul 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.
PubMed 17513656Valadan M, Banifatemi S, Yousefshahi F. Preoperative Gabapentin to Prevent Postoperative Shoulder Pain After Laparoscopic Ovarian Cystectomy: A Randomized Clinical Trial. Anesth Pain Med. 2015 Dec 5;5(6):e31524. doi: 10.5812/aapm.31524. eCollection 2015 Dec.
PubMed 26705527Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.
PubMed 18716003Nakhli MS, Kahloul M, Jebali C, Frigui W, Naija W. Effects of Gabapentinoids Premedication on Shoulder Pain and Rehabilitation Quality after Laparoscopic Cholecystectomy: Pregabalin versus Gabapentin. Pain Res Manag. 2018 Jul 9;2018:9834059. doi: 10.1155/2018/9834059. eCollection 2018.
PubMed 30123399
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03241875
- Acronym / sponsor ID
- Nakhli anesthesia sahloul
- Conditions
- Pain, Postoperative, Cholecystectomy, Laparoscopic
- Keywords
- pregabalin, gabapentin, post operative pain, laparoscopic cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 8 Aug 2017 (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.
The aim of this study is to evaluate the effect of premedication with pregabalin or gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.
Detailed description
Preoperative premedication with gabapentins reduces preoperative anxiety, stress response to surgical stimuli, decreases anesthetic use. The incidence of postoperative nausea and vomiting appears to be decreased. The other desired effect of gabapentins is the reduction in the intensity of postoperative pain after laparoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo oral capsulePatients receive 2 capsules as placebo 2 hours before anesthesia. The capsules are delivered by the hospital pharmacy. |
| pregabalin | Experimental | Drug: Pregabalin 75mgpatients receive 2 capsules of pregabalin (pregabalin 75), two hours before anesthesia. |
| gabapentin | Experimental | Drug: Gabapentin 300mgpatients receive 2 capsules of gabapentin (gabapentin 300), two hours before anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- uncomplicated laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) status < 3
Key exclusion criteria (7 listed)
- acute cholecystitis
- conversion to open cholecystectomy
- history of epilepsia, psychiatric disorders and cognitive impairment
- Pregnancy and breastfeeding
- allergy to pregabalin and/or gabapentin
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 |
|---|---|---|
| Pregabalin 75mgIn this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction. | Drug | pregabalin |
| Gabapentin 300mgIn this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction. | Drug | gabapentin |
| Placebo oral capsuleAlso: placeboIn this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction. | Drug | placebo |
Primary outcome
Post operative shoulder pain
Time frame: VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery
Primary outcome is the intensity of shoulder pain during the first 48 hours after laparoscopic cholecystectomy using the visual analog scale (VAS).
3 secondary outcomes
remifentanil consumption during anesthesia
Time frame: one hour after tracheal tube removal
Post operative sleep quality during the first night
Time frame: first night after surgery
Post operative nausea and vomiting
Time frame: 2, 6, 12, 24 and 48 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 2 Oct 2017.
- Results publication: PubMed 17513656Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.
- Results publication: PubMed 26705527Valadan M, Banifatemi S, Yousefshahi F. Preoperative Gabapentin to Prevent Postoperative Shoulder Pain After Laparoscopic Ovarian Cystectomy: A Randomized Clinical Trial. Anesth Pain Med. 2015 Dec 5;5(6):e31524. doi: 10.5812/aapm.31524. eCollection 2015 Dec.
- Results publication: PubMed 18716003Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.
- Derived from this study: PubMed 30123399Nakhli MS, Kahloul M, Jebali C, Frigui W, Naija W. Effects of Gabapentinoids Premedication on Shoulder Pain and Rehabilitation Quality after Laparoscopic Cholecystectomy: Pregabalin versus Gabapentin. Pain Res Manag. 2018 Jul 9;2018:9834059. doi: 10.1155/2018/9834059. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Said Nakhli, MD principal investigator
Faculty of Medicine, Sousse
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 Pregabalin 75mg and Gabapentin 300mg in people with Pain, Postoperative and Cholecystectomy, Laparoscopic, run by Faculty of Medicine, Sousse 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 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 2 Oct 2017. 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. 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?
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?
Post operative shoulder pain (time frame: VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after 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 NCT03241875, which also lists 4 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 2 Oct 2017.