Cholecystitis, ChronicNCT07131527
Comparison Between Oral Gabapentin Versus Diclofenac Sodium in Post-operative Analgesia Laparoscopic Cholecystectomy
A study testing Gabapentin and Diclofenac Sodium in people with Cholecystitis, Chronic, run by Sohag University at 1 site in Egypt.
Trial summary
this study amis to compare between perioperative oral Gabapentin versus Diclofenac sodium on postoperative analgesia patients undergoing laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cholecystitis, Chronic
- What is being tested?
- Gabapentin and Diclofenac Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jul 2025to 20 Jan 2026
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 60 years old. Both sexes. American Society of Anesthesiologists (ASA) physical status I- II. Patients undergoing laparoscopic cholecystectomy.
Who cannot join
- Patients with hypertension. Pregnant women. Obese patients with BMI >35 kg/m2. Alcoholics. Patients With DM Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between the Efficacy of Pre- Operative Oral Gabapentin Versus Diclofenac Sodium in Post-operative Analgesia in Adult Undergoing Laparoscopic Cholecystectomy
this study amis to compare between perioperative oral Gabapentin versus Diclofenac sodium on postoperative analgesia patients undergoing laparoscopic cholecystectomy
- Conditions
- Cholecystitis, Chronic
- Being tested
- Gabapentin, Diclofenac Sodium
- Medical subject headings
- Cholecystitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
oral Gabapentin will be given 2 hours perioperative as postoperative analgesia patients undergoing laparoscopic cholecystectomy
Diclofenac SodiumDrug
oral diclofenac sodium will be given 2 hours perioperative as postoperative analgesia patients undergoing laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| group A will receive oral Gabapentin | Active comparator | Patients included in this group will receive 600 mg of gabapentin 2 h before surgery. Receives: Drug: Gabapentin |
| group B will receive diclofenac sodium | Active comparator | Patients included in this group will receive 100 mg diclofenac sodium 2 h before surgery. Receives: Drug: Diclofenac Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of preoperative oral Gabapentin versu Diclofenac sodium in adult patient undergoing laparoscopic cholecystectomy
postoperative pain by Numerical Rating Scale (0 represents "no pain" while 10 represents "the worst pain)
Measured: 8 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start14 Jul 2025
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, ChronicStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Zakria Ismail, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131527
- Sponsor's protocol ID
- Soh-Med--25-7-5MS
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abuahmed M, Rashid R. Day-case laparoscopic cholecystectomy in the management of gallbladder disease: a literature review. Langenbecks Arch Surg. 2024 Sep 28;409(1):292. doi: 10.1007/s00423-024-03479-6.
PubMed 39340655Nestor CC, Ng C, Sepulveda P, Irwin MG. Pharmacological and clinical implications of local anaesthetic mixtures: a narrative review. Anaesthesia. 2022 Mar;77(3):339-350. doi: 10.1111/anae.15641. Epub 2021 Dec 14.
PubMed 34904711LaForge JM, Urso K, Day JM, Bourgeois CW, Ross MM, Ahmadzadeh S, Shekoohi S, Cornett EM, Kaye AM, Kaye AD. Non-steroidal Anti-inflammatory Drugs: Clinical Implications, Renal Impairment Risks, and AKI. Adv Ther. 2023 May;40(5):2082-2096. doi: 10.1007/s12325-023-02481-6. Epub 2023 Mar 22.
PubMed 36947330
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Efficacy of Pre- Operative Oral Gabapentin Versus Diclofenac Sodium in Post-operative Analgesia in Adult Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07131527
- Acronym / sponsor ID
- Soh-Med--25-7-5MS
- Conditions
- Cholecystitis, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 20 Aug 2025 (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 amis to compare between perioperative oral Gabapentin versus Diclofenac sodium on postoperative analgesia patients undergoing laparoscopic cholecystectomy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A will receive oral Gabapentin | Active comparator | Drug: GabapentinPatients included in this group will receive 600 mg of gabapentin 2 h before surgery. |
| group B will receive diclofenac sodium | Active comparator | Drug: Diclofenac SodiumPatients included in this group will receive 100 mg diclofenac sodium 2 h before surgery. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age from 20 to 60 years old. Both sexes. American Society of Anesthesiologists (ASA) physical status I- II. Patients undergoing laparoscopic cholecystectomy.
Key exclusion criteria (1 listed)
- Patients with hypertension. Pregnant women. Obese patients with BMI >35 kg/m2. Alcoholics. Patients With DM Patient refusal
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 will be given 2 hours perioperative as postoperative analgesia patients undergoing laparoscopic cholecystectomy | Drug | group A will receive oral Gabapentin |
| Diclofenac Sodiumoral diclofenac sodium will be given 2 hours perioperative as postoperative analgesia patients undergoing laparoscopic cholecystectomy | Drug | group B will receive diclofenac sodium |
Primary outcome
the effect of preoperative oral Gabapentin versu Diclofenac sodium in adult patient undergoing laparoscopic cholecystectomy
Time frame: 8 hours after operation
postoperative pain by Numerical Rating Scale (0 represents "no pain" while 10 represents "the worst pain)
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 9 Jul 2026.
- Background: PubMed 39340655Abuahmed M, Rashid R. Day-case laparoscopic cholecystectomy in the management of gallbladder disease: a literature review. Langenbecks Arch Surg. 2024 Sep 28;409(1):292. doi: 10.1007/s00423-024-03479-6.
- Background: PubMed 34904711Nestor CC, Ng C, Sepulveda P, Irwin MG. Pharmacological and clinical implications of local anaesthetic mixtures: a narrative review. Anaesthesia. 2022 Mar;77(3):339-350. doi: 10.1111/anae.15641. Epub 2021 Dec 14.
- Background: PubMed 36947330LaForge JM, Urso K, Day JM, Bourgeois CW, Ross MM, Ahmadzadeh S, Shekoohi S, Cornett EM, Kaye AM, Kaye AD. Non-steroidal Anti-inflammatory Drugs: Clinical Implications, Renal Impairment Risks, and AKI. Adv Ther. 2023 May;40(5):2082-2096. doi: 10.1007/s12325-023-02481-6. Epub 2023 Mar 22.
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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 study testing Gabapentin and Diclofenac Sodium in people with Cholecystitis, Chronic, run by Sohag 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 1 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 9 Jul 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 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. 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?
the effect of preoperative oral Gabapentin versu Diclofenac sodium in adult patient undergoing laparoscopic cholecystectomy (time frame: 8 hours after operation). 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 NCT07131527, which also lists 3 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 9 Jul 2026.