Laparoscopic Abdominal SurgeriesNCT07456761
Effect of Low-dose Pregabalin Retard (82.5 mg) Versus Standard-dose Pregabalin Retard (165 mg) on Postoperative Pain and Opioid Consumption After Elective Laparoscopic Abdominal Surgery
A study testing Pregabalin retard 82.5 mg and Pregabalin retard 165 mg in people with Laparoscopic Abdominal Surgeries, run by South Egypt Cancer Institute.
Trial summary
The goal of this clinical trial is to detect whether pregabalin retard (82.5 mg or 165 mg) improves analgesia after elective laparoscopic abdominal surgery in adults. It will also evaluate the safety of both doses. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laparoscopic Abdominal Surgeries
- What is being tested?
- Pregabalin retard 82.5 mg and Pregabalin retard 165 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- ASA physical status I-III
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia (e.g. laparoscopic cholecystectomy, appendectomy, diagnostic/therapeutic laparoscopic procedures without expected conversion to open surgery)
- Ability to understand the NRS pain scale and the study procedures
- Written informed consent obtained
Who cannot join
- Known allergy or intolerance to pregabalin, gabapentinoids, or study medications
- Chronic opioid use (daily use >30 mg oral morphine equivalent for >2 weeks preoperatively)
- Regular use of gabapentin or pregabalin within 30 days
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or on dialysis
- Severe hepatic impairment (Child-Pugh C)
- Uncontrolled epilepsy or other major neurological disorder
Show all 10Show fewer
- Severe psychiatric disease, alcohol or substance abuse
- Pregnancy or breastfeeding
- Planned postoperative ICU admission for reasons other than routine overnight monitoring
- Conversion to open abdominal surgery (these patients will be analyzed in sensitivity or excluded, predefined in analysis plan)
About this study
Official title: Effect of Low-dose Pregabalin Retard (82.5 mg) Versus Standard-dose Pregabalin Retard (165 mg) on Postoperative Pain and Opioid Consumption After Elective Laparoscopic Abdominal Surgery: a Randomized, Double-blind, Controlled Trial
The goal of this clinical trial is to detect whether pregabalin retard (82.5 mg or 165 mg) improves analgesia after elective laparoscopic abdominal surgery in adults. It will also evaluate the safety of both doses.
The main questions it aims to answer are:
Read more
Does the higher dose (165 mg) reduce the total amount of opioids needed in the first 24 hours after surgery compared to the lower dose (82.5 mg)? Do the pain scores differ between the two doses? Are there differences in side effects between the two doses?
Researchers will compare two different doses of pregabalin retard to determine which provides better pain control with fewer side effects.
Participants will:
Take one dose of pregabalin retard (82.5 mg or 165 mg) before surgery Receive standard anesthesia and multimodal pain treatment Have their pain levels and opioid use monitored for 24 hours after surgery Be assessed for side effects such as dizziness, nausea, or sedation
- Conditions
- Laparoscopic Abdominal Surgeries
- Being tested
- Pregabalin retard 82.5 mg, Pregabalin retard 165 mg
- Keywords
- Pregabalin, Pain scores, Total opioid consumption, Laparoscopic abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin retard 82.5 mgDrug
Oral Administration 1-2 hours before elective laparoscopic abdominal surgery
Pregabalin retard 165 mgDrug
Oral Administration 1-2 hours before elective laparoscopic abdominal surgery
| Study group | Role | What they receive |
|---|---|---|
| Group I (Low dose) | Active comparator | Participants of this Arm will take pregabalin retard 82.5 mg orally with a sip of water, 1-2 hours before induction of anesthesia. Receives: Drug: Pregabalin retard 82.5 mg |
| Group II (High dose) | Active comparator | Participants of this Arm will take pregabalin retard 165 mg orally with a sip of water, 1-2 hours before induct Receives: Drug: Pregabalin retard 165 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption (IV morphine equivalents) during the first 24 postoperative hours
Measured: 24 hours
Secondary outcomes (1)
Postoperative pain intensity
Visual Analog Scale (0-10) at rest and during movement at predefined time points (2,4, 6,8 12,18 and 24h).
Measured: 2-24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Abdominal SurgeriesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Gamal Thabet Ahmed, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456761
- Sponsor's protocol ID
- 18-2026-809
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-dose Pregabalin Retard (82.5 mg) Versus Standard-dose Pregabalin Retard (165 mg) on Postoperative Pain and Opioid Consumption After Elective Laparoscopic Abdominal Surgery: a Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07456761
- Acronym / sponsor ID
- 18-2026-809
- Conditions
- Laparoscopic Abdominal Surgeries
- Keywords
- Pregabalin, Pain scores, Total opioid consumption, Laparoscopic abdominal surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Mar 2026 (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 goal of this clinical trial is to detect whether pregabalin retard (82.5 mg or 165 mg) improves analgesia after elective laparoscopic abdominal surgery in adults. It will also evaluate the safety of both doses.
The main questions it aims to answer are:
Does the higher dose (165 mg) reduce the total amount of opioids needed in the first 24 hours after surgery compared to the lower dose (82.5 mg)? Do the pain scores differ between the two doses? Are there differences in side effects between the two doses?
Researchers will compare two different doses of pregabalin retard to determine which provides better pain control with fewer side effects.
Participants will:
Take one dose of pregabalin retard (82.5 mg or 165 mg) before surgery Receive standard anesthesia and multimodal pain treatment Have their pain levels and opioid use monitored for 24 hours after surgery Be assessed for side effects such as dizziness, nausea, or sedation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Low dose) | Active comparator | Drug: Pregabalin retard 82.5 mgParticipants of this Arm will take pregabalin retard 82.5 mg orally with a sip of water, 1-2 hours before induction of anesthesia. |
| Group II (High dose) | Active comparator | Drug: Pregabalin retard 165 mgParticipants of this Arm will take pregabalin retard 165 mg orally with a sip of water, 1-2 hours before induct |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years
- ASA physical status I-III
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia (e.g. laparoscopic cholecystectomy, appendectomy, diagnostic/therapeutic laparoscopic procedures without expected conversion to open surgery)
- Ability to understand the NRS pain scale and the study procedures
- Written informed consent obtained
Key exclusion criteria (10 listed)
- Known allergy or intolerance to pregabalin, gabapentinoids, or study medications
- Chronic opioid use (daily use >30 mg oral morphine equivalent for >2 weeks preoperatively)
- Regular use of gabapentin or pregabalin within 30 days
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or on dialysis
- Severe hepatic impairment (Child-Pugh C)
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 retard 82.5 mgOral Administration 1-2 hours before elective laparoscopic abdominal surgery | Drug | Group I (Low dose) |
| Pregabalin retard 165 mgOral Administration 1-2 hours before elective laparoscopic abdominal surgery | Drug | Group II (High dose) |
Primary outcome
Cumulative opioid consumption (IV morphine equivalents) during the first 24 postoperative hours
Time frame: 24 hours
1 secondary outcome
Postoperative pain intensity
Time frame: 2-24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
Related trials for Laparoscopic Abdominal Surgeries
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
Recruiting
The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption
Dexmedetomidine, Total Intravenous Anesthesia
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin retard 82.5 mg and Pregabalin retard 165 mg in people with Laparoscopic Abdominal Surgeries, run by South Egypt Cancer Institute.
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 5 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: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 opioid consumption (IV morphine equivalents) during the first 24 postoperative hours (time frame: 24 hours). 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 2 Apr 2026.