Post Operative PainPhase 3NCT06616441
The Effect of Intraperitoneal Instillation of Bupivacaine on Postoperative Pain After Surgical Laparoscopy
A Phase 3 study testing Bupivacaine in people with Post Operative Pain, run by El Shatby University Hospital for Obstetrics and Gynecology at 1 site in Egypt.
Trial summary
Pain after surgical laparoscopy is due to various causes, such as : trocar insertion stimulating somatic pain receptors in the skin ,chemical irritation of peritoneal nerves due to abdominal distension by CO2 which is transformed into carbonic acid in nerves, distention secondary to pneumoperitoneum causes mechanical… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 15 Sep 2024
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients those are indicated for surgical laparoscopy, whatever the gynecological problem.
- Age between (18-50) years.
- Cooperative patient that can express pain and score it.
Who cannot join
- Non-cooperative patients that cannot express and score pain.
- Drug abusers due to altered pain threshold.
- Surgical laparoscopy indicated for oncological procedures.
- Any allergy or reaction to any of the derivatives of bupivacaine drug group.
- Any cardio-pulmonary condition.
Trial locations and contacts
1 site in 1 country.
About this study
Pain after surgical laparoscopy is due to various causes, such as : trocar insertion stimulating somatic pain receptors in the skin ,chemical irritation of peritoneal nerves due to abdominal distension by CO2 which is transformed into carbonic acid in nerves, distention secondary to pneumoperitoneum causes mechanical irritation of visceral and parietal nerves of the peritoneum, furthermore the surgical intervention causing injury and inflammation of the tissues, spillage of blood or serous fluid causing more irritation to the visceral and parietal nerves of the peritoneum which leads to visceral dull aching pain referred mainly to the distribution of the nerve dermatomal area.
Unfortunately, pain is the major complaint of the patients, thus making its evaluation a fundamental requisite in the outcome assessment in our practice. Pain intensity, duration and related disability are the aspects that define pain and its effects. For each of these aspects, different assessment tools exist.
Read more
Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints.
There are numerous interventions that are associated with reduction in the incidence, severity or both of pain or a reduction in analgesia requirements for women having surgical laparoscopy for gynecological purposes.
Bupivacaine, is a local anesthetic. In nerve blocks, it is injected around the nerve that supplies a certain area, or into the spinal canal's epidural space, bupivacaine binds to the intracellular portion of voltage-gated sodium channels and blocks sodium influx into nerve cells, which prevents depolarization. Without depolarization, no initiation or conduction of a pain signal can occur.
Hence the idea of our study is to instill bupivacaine in a certain concentration in the peritoneal cavity in an attempt to reduce postoperative pain after surgical laparoscopy for gynecological purposes that will inflect certainly on patient's hospital stay and mobility.
Read the detailed description
This randomized controlled trial will be conducted for (80) women undergoing laparoscopic procedures at endoscopy unit at El-Shatby Maternity University Hospital, after approval of ethical committee of Alexandria Faculty of Medicine.
Randomization will be through opaque sealed envelopes.
After signing their informed consents, the patients who are included in the study will be divided into two groups each group include (60) patients.
Group A: Patients that will receive intraoperative instillation of bupivacaine. Group B: (Control group) that will not receive the medication.
The patients in both groups will be subjected to:
Pre-operative:
History taking (gynecological, obstetric, medical any drug reaction and surgical), general examination and abdominal examination.
Intra-operative:
premedication : 1.5 microgram/kg fentanyl IV induction of anathesia: 2mg/kg Propofol IV , 0.5 mg/kg Atracurium IV , ventilation via face mask 2-3 minutes , then endotracheal intubation
1gm paracetamol IV as intraoperative analgesia which will not interfere with postoperative pain scoring.
Group (A) only will receive intra-peritoneal 40 ml bupivacaine 0.2%, after laparoscopic procedure before removing trocars.
- Conditions
- Post Operative Pain
- Being tested
- Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Group (A) only will receive intra-peritoneal 40 ml bupivacaine 0.2%, after laparoscopic procedure before removing trocars.
| Study group | Role | What they receive |
|---|---|---|
| Grouo A | Active comparator | Patients that will receive intraoperative instillation of bupivacaine. Receives: Drug: Bupivacaine |
| Group B | No intervention | (Control group) that will not receive the medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of instilling bupivacaine intraperitoneal in reducing postoperative pain after surgical laparoscopy for gynecologic procedures.
Evaluate the efficacy of instilling bupivacaine intraperitoneal in reducing postoperative pain after surgical laparoscopy for gynecologic procedures.
Measured: up to 1 day
Secondary outcomes (3)
Assessment of the timing passed postoperative, since the patient needs to start the first analgesic dose.
Assessment of the timing passed postoperative, since the patient needs to start the first analgesic dose.
Measured: up to 1 day
Frequency of analgesia requested by the patient in postoperative period.
Frequency of analgesia requested by the patient in postoperative period.
Measured: up to 1 day
Assessment of the time passed postoperative since the patient start mobility
Assessment of the time passed postoperative since the patient start mobility
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jun 2023
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Post Operative 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- El Shatby University Hospital for Obstetrics and Gynecology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aly Hussein, El Shatby University Hospital for Obstetrics and Gynecology
- Investigators
- Aly Hussein, Dr, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616441
- Sponsor's protocol ID
- 0107909
- Status last verified
- Sep 2024
- First submitted
- 4 Dec 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Cho M, Kim CJ, Hahm TS, Lee YY, Kim TJ, Lee JW, Kim BG, Bae DS, Choi CH. Combination of a pulmonary recruitment maneuver and intraperitoneal bupivacaine for the reduction of postoperative shoulder pain in gynecologic laparoscopy: a randomized, controlled trial. Obstet Gynecol Sci. 2020 Mar;63(2):187-194. doi: 10.5468/ogs.2020.63.2.187. Epub 2020 Feb 20.
PubMed 32206659Cunningham TK, Draper H, Bexhell H, Allgar V, Allen J, Mikl D, Phillips K. A double-blinded randomised controlled study to investigate the effect of intraperitoneal levobupivacaine on post laparoscopic pain. Facts Views Vis Obgyn. 2020 Oct 8;12(3):155-161.
PubMed 33123690Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
PubMed 16320034Adlan ASA, Azhary JMK, Tarmidzi HZM, Kamarudin M, Lim RCS, Ng DSW. Post Laparoscopy Pain Reduction Project I (POLYPREP I): intraperitoneal normal saline instillation-a randomised controlled trial. BMC Womens Health. 2022 Apr 12;22(1):116. doi: 10.1186/s12905-022-01696-z.
PubMed 35413905Sao CH, Chan-Tiopianco M, Chung KC, Chen YJ, Horng HC, Lee WL, Wang PH. Pain after laparoscopic surgery: Focus on shoulder-tip pain after gynecological laparoscopic surgery. J Chin Med Assoc. 2019 Nov;82(11):819-826. doi: 10.1097/JCMA.0000000000000190.
PubMed 31517775Kaloo P, Armstrong S, Kaloo C, Jordan V. Interventions to reduce shoulder pain following gynaecological laparoscopic procedures. Cochrane Database Syst Rev. 2019 Jan 30;1(1):CD011101. doi: 10.1002/14651858.CD011101.pub2.
PubMed 30699235Jimenez Cruz J, Diebolder H, Dogan A, Mothes A, Rengsberger M, Hartmann M, Meissner W, Runnebaum IB. Combination of pre-emptive port-site and intraoperative intraperitoneal ropivacaine for reduction of postoperative pain: a prospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2014 Aug;179:11-6. doi: 10.1016/j.ejogrb.2014.05.001. Epub 2014 May 13.
PubMed 24965972Arden D, Seifert E, Donnellan N, Guido R, Lee T, Mansuria S. Intraperitoneal instillation of bupivacaine for reduction of postoperative pain after laparoscopic hysterectomy: a double-blind randomized controlled trial. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):620-6. doi: 10.1016/j.jmig.2013.03.012. Epub 2013 May 22.
PubMed 23706546Manjunath AP, Chhabra N, Girija S, Nair S. Pain relief in laparoscopic tubal ligation using intraperitoneal lignocaine: a double masked randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):110-4. doi: 10.1016/j.ejogrb.2012.06.035. Epub 2012 Jul 21.
PubMed 22819575Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):545-53. doi: 10.1016/j.jmig.2012.04.002. Epub 2012 Jul 3.
PubMed 22763313Malhotra N, Chanana C, Roy KK, Kumar S, Rewari V, Sharma JB. To compare the efficacy of two doses of intraperitoneal bupivacaine for pain relief after operative laparoscopy in gynecology. Arch Gynecol Obstet. 2007 Oct;276(4):323-6. doi: 10.1007/s00404-007-0337-1. Epub 2007 Jul 25.
PubMed 17653742Chou YJ, Ou YC, Lan KC, Jawan B, Chang SY, Kung FT. Preemptive analgesia installation during gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):330-5. doi: 10.1016/j.jmig.2005.05.005.
PubMed 16036193Buck L, Varras MN, Miskry T, Ruston J, Magos A. Intraperitoneal bupivacaine for the reduction of postoperative pain following operative laparoscopy: a pilot study and review of the literature. J Obstet Gynaecol. 2004 Jun;24(4):448-51. doi: 10.1080/01443610410001685637.
PubMed 15203590
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraperitoneal Instillation of Bupivacaine on Postoperative Pain After Surgical Laparoscopy
- ClinicalTrials.gov ID
- NCT06616441
- Acronym / sponsor ID
- 0107909
- Conditions
- Post Operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- El Shatby University Hospital for Obstetrics and GynecologyUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 27 Sep 2024 (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.
Pain after surgical laparoscopy is due to various causes, such as : trocar insertion stimulating somatic pain receptors in the skin ,chemical irritation of peritoneal nerves due to abdominal distension by CO2 which is transformed into carbonic acid in nerves, distention secondary to pneumoperitoneum causes mechanical irritation of visceral and parietal nerves of the peritoneum, furthermore the surgical intervention causing injury and inflammation of the tissues, spillage of blood or serous fluid causing more irritation to the visceral and parietal nerves of the peritoneum which leads to visceral dull aching pain referred mainly to the distribution of the nerve dermatomal area.
Unfortunately, pain is the major complaint of the patients, thus making its evaluation a fundamental requisite in the outcome assessment in our practice. Pain intensity, duration and related disability are the aspects that define pain and its effects. For each of these aspects, different assessment tools exist.
Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints.
There are numerous interventions that are associated with reduction in the incidence, severity or both of pain or a reduction in analgesia requirements for women having surgical laparoscopy for gynecological purposes.
Bupivacaine, is a local anesthetic. In nerve blocks, it is injected around the nerve that supplies a certain area, or into the spinal canal's epidural space, bupivacaine binds to the intracellular portion of voltage-gated sodium channels and blocks sodium influx into nerve cells, which prevents depolarization. Without depolarization, no initiation or conduction of a pain signal can occur.
Hence the idea of our study is to instill bupivacaine in a certain concentration in the peritoneal cavity in an attempt to reduce postoperative pain after surgical laparoscopy for gynecological purposes that will inflect certainly on patient's hospital stay and mobility.
Detailed description
This randomized controlled trial will be conducted for (80) women undergoing laparoscopic procedures at endoscopy unit at El-Shatby Maternity University Hospital, after approval of ethical committee of Alexandria Faculty of Medicine.
Randomization will be through opaque sealed envelopes.
After signing their informed consents, the patients who are included in the study will be divided into two groups each group include (60) patients.
Group A: Patients that will receive intraoperative instillation of bupivacaine. Group B: (Control group) that will not receive the medication.
The patients in both groups will be subjected to:
Pre-operative:
History taking (gynecological, obstetric, medical any drug reaction and surgical), general examination and abdominal examination.
Intra-operative:
premedication : 1.5 microgram/kg fentanyl IV induction of anathesia: 2mg/kg Propofol IV , 0.5 mg/kg Atracurium IV , ventilation via face mask 2-3 minutes , then endotracheal intubation
1gm paracetamol IV as intraoperative analgesia which will not interfere with postoperative pain scoring.
Group (A) only will receive intra-peritoneal 40 ml bupivacaine 0.2%, after laparoscopic procedure before removing trocars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grouo A | Active comparator | Drug: BupivacainePatients that will receive intraoperative instillation of bupivacaine. |
| Group B | No intervention | –(Control group) that will not receive the medication. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients those are indicated for surgical laparoscopy, whatever the gynecological problem.
- Age between (18-50) years.
- Cooperative patient that can express pain and score it.
Key exclusion criteria (5 listed)
- Non-cooperative patients that cannot express and score pain.
- Drug abusers due to altered pain threshold.
- Surgical laparoscopy indicated for oncological procedures.
- Any allergy or reaction to any of the derivatives of bupivacaine drug group.
- Any cardio-pulmonary condition.
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 |
|---|---|---|
| BupivacaineGroup (A) only will receive intra-peritoneal 40 ml bupivacaine 0.2%, after laparoscopic procedure before removing trocars. | Drug | Grouo A |
Primary outcome
Evaluate the efficacy of instilling bupivacaine intraperitoneal in reducing postoperative pain after surgical laparoscopy for gynecologic procedures.
Time frame: up to 1 day
Evaluate the efficacy of instilling bupivacaine intraperitoneal in reducing postoperative pain after surgical laparoscopy for gynecologic procedures.
3 secondary outcomes
Assessment of the timing passed postoperative, since the patient needs to start the first analgesic dose.
Time frame: up to 1 day
Frequency of analgesia requested by the patient in postoperative period.
Time frame: up to 1 day
Assessment of the time passed postoperative since the patient start mobility
Time frame: up to 1 day
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 27 Sep 2024.
- Background: PubMed 32206659Cho M, Kim CJ, Hahm TS, Lee YY, Kim TJ, Lee JW, Kim BG, Bae DS, Choi CH. Combination of a pulmonary recruitment maneuver and intraperitoneal bupivacaine for the reduction of postoperative shoulder pain in gynecologic laparoscopy: a randomized, controlled trial. Obstet Gynecol Sci. 2020 Mar;63(2):187-194. doi: 10.5468/ogs.2020.63.2.187. Epub 2020 Feb 20.
- Background: PubMed 33123690Cunningham TK, Draper H, Bexhell H, Allgar V, Allen J, Mikl D, Phillips K. A double-blinded randomised controlled study to investigate the effect of intraperitoneal levobupivacaine on post laparoscopic pain. Facts Views Vis Obgyn. 2020 Oct 8;12(3):155-161.
- Background: PubMed 16320034Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
- Background: PubMed 35413905Adlan ASA, Azhary JMK, Tarmidzi HZM, Kamarudin M, Lim RCS, Ng DSW. Post Laparoscopy Pain Reduction Project I (POLYPREP I): intraperitoneal normal saline instillation-a randomised controlled trial. BMC Womens Health. 2022 Apr 12;22(1):116. doi: 10.1186/s12905-022-01696-z.
- Background: PubMed 31517775Sao CH, Chan-Tiopianco M, Chung KC, Chen YJ, Horng HC, Lee WL, Wang PH. Pain after laparoscopic surgery: Focus on shoulder-tip pain after gynecological laparoscopic surgery. J Chin Med Assoc. 2019 Nov;82(11):819-826. doi: 10.1097/JCMA.0000000000000190.
- Background: PubMed 30699235Kaloo P, Armstrong S, Kaloo C, Jordan V. Interventions to reduce shoulder pain following gynaecological laparoscopic procedures. Cochrane Database Syst Rev. 2019 Jan 30;1(1):CD011101. doi: 10.1002/14651858.CD011101.pub2.
- Background: PubMed 24965972Jimenez Cruz J, Diebolder H, Dogan A, Mothes A, Rengsberger M, Hartmann M, Meissner W, Runnebaum IB. Combination of pre-emptive port-site and intraoperative intraperitoneal ropivacaine for reduction of postoperative pain: a prospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2014 Aug;179:11-6. doi: 10.1016/j.ejogrb.2014.05.001. Epub 2014 May 13.
- Background: PubMed 23706546Arden D, Seifert E, Donnellan N, Guido R, Lee T, Mansuria S. Intraperitoneal instillation of bupivacaine for reduction of postoperative pain after laparoscopic hysterectomy: a double-blind randomized controlled trial. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):620-6. doi: 10.1016/j.jmig.2013.03.012. Epub 2013 May 22.
- Background: PubMed 22819575Manjunath AP, Chhabra N, Girija S, Nair S. Pain relief in laparoscopic tubal ligation using intraperitoneal lignocaine: a double masked randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):110-4. doi: 10.1016/j.ejogrb.2012.06.035. Epub 2012 Jul 21.
- Background: PubMed 22763313Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):545-53. doi: 10.1016/j.jmig.2012.04.002. Epub 2012 Jul 3.
- Background: PubMed 17653742Malhotra N, Chanana C, Roy KK, Kumar S, Rewari V, Sharma JB. To compare the efficacy of two doses of intraperitoneal bupivacaine for pain relief after operative laparoscopy in gynecology. Arch Gynecol Obstet. 2007 Oct;276(4):323-6. doi: 10.1007/s00404-007-0337-1. Epub 2007 Jul 25.
- Background: PubMed 16036193Chou YJ, Ou YC, Lan KC, Jawan B, Chang SY, Kung FT. Preemptive analgesia installation during gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):330-5. doi: 10.1016/j.jmig.2005.05.005.
- Individual participant dataSharing planned: Yes
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Aly Hussein, Dr principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine in people with Post Operative Pain, run by El Shatby University Hospital for Obstetrics and Gynecology 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 3 inclusion and 5 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 27 Sep 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluate the efficacy of instilling bupivacaine intraperitoneal in reducing postoperative pain after surgical laparoscopy for gynecologic procedures. (time frame: up to 1 day). 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 NCT06616441, which also lists 13 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 27 Sep 2024.