Breast Cancer Surgery PainNCT07804784
Postoperative Analgesic Consumption After Preoperative Gabapentin vs Placebo in Breast Cancer Surgery
A study testing Oral Gabapentin pre-op and Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) in people with Breast Cancer Surgery Pain, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
The study will be conducted after approval from the Scientific and Ethical Review Committees. Eligible patients will be enrolled after obtaining written informed consent and randomly allocated to Group A (gabapentin) or Group B (placebo). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer Surgery Pain
- What is being tested?
- Oral Gabapentin pre-op and Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 30 Jun 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 to 60 years.
- Female Gender
- American Society of Anesthesiologists grade 1 and 2 patients.
- Elective breast surgery
- Admitted and day case surgeries
Who cannot join
- Patients allergic to gabapentin
- Patients refusal.
- Patients having a history of chronic pain.
- Patients already using opioids for pain control
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaukat Khanum Memorial Cancer Hospital and Research Centre
Lahore, Punjab Province, 5400
About this study
Official title: Comparison of Mean Analgesia Consumption for Postoperative Pain With Single Dose of Preoperative Oral Gabapentin Versus Placebo in Patients Undergoing Breast Cancer Surgery
The study will be conducted after approval from the Scientific and Ethical Review Committees. Eligible patients will be enrolled after obtaining written informed consent and randomly allocated to Group A (gabapentin) or Group B (placebo). Group A will receive oral gabapentin 600 mg one hour before surgery, while Group B will receive oral placebo (sodium bicarbonate) at the same time.
General anesthesia will be induced with propofol, atracurium, and fentanyl and maintained with sevoflurane using a supraglottic airway device. Both groups will receive IV paracetamol, ketorolac, and local bupivacaine infiltration. Intraoperative rescue analgesia with IV morphine will be given if hemodynamic parameters increase by >20% from baseline.
Postoperatively, patients will be monitored in the recovery area for pain using the Numeric Rating Scale (NRS) and for adverse effects including drowsiness, nausea, and vomiting. IV morphine 0.1 mg/kg will be administered if the NRS pain score is >2. The total morphine consumption during recovery will be recorded for both groups. Data will be collected using the attached proforma.
Read the detailed description
This study will be carried out after approval from scientific and ethical review committee. Patient who fulfill the criteria will be enrolled in this study. Written and informed consent will be taken from study participants. Patients will be randomly allocated (as mentioned above) either in to group A (Gabapentin) or group B (placebo). Patients in Group A will be given oral gabapentin 600 mg10 one hour before surgery while patients in group B will be given oral placebo (Tablet sodium bicarbonate) one hour before surgery. . Induction of anesthesia will be done using propofol 1.5-2 mg/kg, atracurium 0.5 mg/kg and fentanyl 1 mcg/kg. Both group of patients will undergo general anesthesia with supra glottic airway device. Anesthesia will be maintained using sevoflurane using MAC 0.8-1.0. Both group of patients will receive intravenous paracetamol 1 gram, ketorolac 30 mg and local infiltration (bupivacaine) upto 2mg/kg. Intravenous morphine (0.1 mg/kg) will be administered intra operatively as rescue analgesia if blood pressure or/and heart rate increases 20 % above baseline. Ondansetron IV, 4 mg, was administered 30 minutes before to the conclusion of operation. After surgery patients will be transferred to recovery area. Patients will be monitored for pain score for a period of their whole stay in recovery area using numeric rating scale. The post-anesthesia care unit was transferred with the patients. In recovery area, adverse effects such pain, drowsiness, nausea, vomiting, and others were monitored. If the pain is score is greater than 2, then intra venous morphine 0.1 mg/kg will be administered as a bolus. Therefore in both group of patients total morphine used for each patient during their stay in recovery will be noted. Data will be collected on Performa attached at the end.
- Conditions
- Breast Cancer Surgery Pain
- Being tested
- Oral Gabapentin pre-op, Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)
- Keywords
- Gabapentin, Breast neoplasm, pain, postoperative, analgesics, opoid, morphine
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Gabapentin pre-opDrug
A single perioperative 600 mg dose of oral Gabapentin significantly reduces intraoperative and postoperative morphine consumption.
Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)Drug
A single perioperative dose of oral Vitamin B complex tablet given as Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients in Group A were given oral Gabapentin 600 mg preoperatively. Receives: Drug: Oral Gabapentin pre-op |
| Group B | Placebo comparator | Patients in Group B were given Oral Vitamins B tablets perioperativey Receives: Drug: Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare post-operative mean morphine consumption between Single Dose of Preoperative Oral Gabapentin versus Placebo in Patients Undergoing Breast Surgery
This study aims to compare postoperative morphine consumption in patients undergoing breast surgery who receive a single preoperative dose of oral gabapentin versus placebo. The primary outcome will be the total amount of morphine required during the postoperative recovery period. The study will determine whether preoperative gabapentin reduces postoperative opioid requirements and improves pain management.
Measured: 2 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Jan 2026
- Primary completion30 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Surgery PainStudies 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
- Model description
- Randomized controlled trial. STUDY SETTING: Hospital: Shaukat khanum Memorial hospital Lahore Department: Anesthesia department DURATION: 6 months after approval of synopsis. SAMPLE SIZE: The sample size is calculated by using an open epi WHO sample size calculator. Taking relevant statistics from previous study10 for the gabapentin group as post-operative mean morphine consumption 11.0 mg and standard deviation (SD) 2.0 mg and for placebo mean morphine consumption 13.1 mg and standard deviation (SD) 2.25 mg10. Power of study 95 %, 95 % Confidence interval (CI) and assuming 10% drop-out rate. The calculated sample size came out as 30 patients in each group. The total sample size would be 60 patients.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804784
- Sponsor's protocol ID
- IRB-24-11
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Modak SD, Magar J, Kakad V. Pre-emptive gabapentin for postoperative pain relief in abdominal hysterectomy. International Journal of Research in Medical Sciences 2016;4(9):3755-9
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mean Analgesia Consumption for Postoperative Pain With Single Dose of Preoperative Oral Gabapentin Versus Placebo in Patients Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT07804784
- Acronym / sponsor ID
- IRB-24-11
- Conditions
- Breast Cancer Surgery Pain
- Keywords
- Gabapentin, Breast neoplasm, pain, postoperative, analgesics, opoid, morphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 4 Sep 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 study will be conducted after approval from the Scientific and Ethical Review Committees. Eligible patients will be enrolled after obtaining written informed consent and randomly allocated to Group A (gabapentin) or Group B (placebo). Group A will receive oral gabapentin 600 mg one hour before surgery, while Group B will receive oral placebo (sodium bicarbonate) at the same time.
General anesthesia will be induced with propofol, atracurium, and fentanyl and maintained with sevoflurane using a supraglottic airway device. Both groups will receive IV paracetamol, ketorolac, and local bupivacaine infiltration. Intraoperative rescue analgesia with IV morphine will be given if hemodynamic parameters increase by >20% from baseline.
Postoperatively, patients will be monitored in the recovery area for pain using the Numeric Rating Scale (NRS) and for adverse effects including drowsiness, nausea, and vomiting. IV morphine 0.1 mg/kg will be administered if the NRS pain score is >2. The total morphine consumption during recovery will be recorded for both groups. Data will be collected using the attached proforma.
Detailed description
This study will be carried out after approval from scientific and ethical review committee. Patient who fulfill the criteria will be enrolled in this study. Written and informed consent will be taken from study participants. Patients will be randomly allocated (as mentioned above) either in to group A (Gabapentin) or group B (placebo). Patients in Group A will be given oral gabapentin 600 mg10 one hour before surgery while patients in group B will be given oral placebo (Tablet sodium bicarbonate) one hour before surgery. . Induction of anesthesia will be done using propofol 1.5-2 mg/kg, atracurium 0.5 mg/kg and fentanyl 1 mcg/kg. Both group of patients will undergo general anesthesia with supra glottic airway device. Anesthesia will be maintained using sevoflurane using MAC 0.8-1.0. Both group of patients will receive intravenous paracetamol 1 gram, ketorolac 30 mg and local infiltration (bupivacaine) upto 2mg/kg. Intravenous morphine (0.1 mg/kg) will be administered intra operatively as rescue analgesia if blood pressure or/and heart rate increases 20 % above baseline. Ondansetron IV, 4 mg, was administered 30 minutes before to the conclusion of operation. After surgery patients will be transferred to recovery area. Patients will be monitored for pain score for a period of their whole stay in recovery area using numeric rating scale. The post-anesthesia care unit was transferred with the patients. In recovery area, adverse effects such pain, drowsiness, nausea, vomiting, and others were monitored. If the pain is score is greater than 2, then intra venous morphine 0.1 mg/kg will be administered as a bolus. Therefore in both group of patients total morphine used for each patient during their stay in recovery will be noted. Data will be collected on Performa attached at the end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized controlled trial. STUDY SETTING: Hospital: Shaukat khanum Memorial hospital Lahore Department: Anesthesia department DURATION: 6 months after approval of synopsis. SAMPLE SIZE: The sample size is calculated by using an open epi WHO sample size calculator. Taking relevant statistics from previous study10 for the gabapentin group as post-operative mean morphine consumption 11.0 mg and standard deviation (SD) 2.0 mg and for placebo mean morphine consumption 13.1 mg and standard deviation (SD) 2.25 mg10. Power of study 95 %, 95 % Confidence interval (CI) and assuming 10% drop-out rate. The calculated sample size came out as 30 patients in each group. The total sample size would be 60 patients.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Oral Gabapentin pre-opPatients in Group A were given oral Gabapentin 600 mg preoperatively. |
| Group B | Placebo comparator | Drug: Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)Patients in Group B were given Oral Vitamins B tablets perioperativey |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 to 60 years.
- Female Gender
- American Society of Anesthesiologists grade 1 and 2 patients.
- Elective breast surgery
- Admitted and day case surgeries
Key exclusion criteria (4 listed)
- Patients allergic to gabapentin
- Patients refusal.
- Patients having a history of chronic pain.
- Patients already using opioids for pain control
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 |
|---|---|---|
| Oral Gabapentin pre-opA single perioperative 600 mg dose of oral Gabapentin significantly reduces intraoperative and postoperative morphine consumption. | Drug | Group A |
| Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)A single perioperative dose of oral Vitamin B complex tablet given as Placebo. | Drug | Group B |
Primary outcome
To compare post-operative mean morphine consumption between Single Dose of Preoperative Oral Gabapentin versus Placebo in Patients Undergoing Breast Surgery
Time frame: 2 hours post surgery
This study aims to compare postoperative morphine consumption in patients undergoing breast surgery who receive a single preoperative dose of oral gabapentin versus placebo. The primary outcome will be the total amount of morphine required during the postoperative recovery period. The study will determine whether preoperative gabapentin reduces postoperative opioid requirements and improves pain management.
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 4 Sep 2026.
- Results publicationModak SD, Magar J, Kakad V. Pre-emptive gabapentin for postoperative pain relief in abdominal hysterectomy. International Journal of Research in Medical Sciences 2016;4(9):3755-9
- 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.
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 Oral Gabapentin pre-op and Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) in people with Breast Cancer Surgery Pain, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
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 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 4 Sep 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 Pakistan. 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.
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?
To compare post-operative mean morphine consumption between Single Dose of Preoperative Oral Gabapentin versus Placebo in Patients Undergoing Breast Surgery (time frame: 2 hours post 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 NCT07804784, which also lists 1 linked publication.
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 4 Sep 2026.