Post-operative PainPhase 4NCT02300480
Effects of Calot's Triangle Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Double-blind, Controlled, Clinical Trial
A Phase 4 study testing CTB group and PCIA group in people with Post-operative Pain and Gallstone Disease, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Chronic pain after laparoscopic cholecystectomy (LC) is a common complication with an incidence ranging between 3-56%. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitization have been suggested to be part of the pathophysiology. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-operative Pain, Gallstone Disease
- What is being tested?
- CTB group and PCIA group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Nov 2015
- 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
- men or woman over 18 the years and younger than 65 years old who will receive selective laparoscopic cholecystectomy.
Who cannot join
- age below 18 years or over 65 years
- American Society of Anesthesiologists grade III or greater
- Diabetes
- chronic pain of any kind other than gallbladder disease
- allergic to local anesthetics
- cognitive impairment or communication problems
Show all 15Show fewer
- peptic ulcer
- received opioids、NSAID or tranquilizers (treatment for over 1 wk before the cholecystectomy)
- history of alcohol or drug abuse
- the operation was converted to an open procedure
- gangrenous cholecystitis
- common bile duct exploration or insertion of a T-drain
- other invasive procedures
- severe hepatic or renal impairment
- post-operative severe complications(e.g. pyogenic infection)
Trial locations and contacts
1 site in 1 country.
China1 site
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Su Min, MD, +86-23-89011068, ms89011068@163.com
Dong Zhang, Master, +86-23-89011061, zdcqmua420@163.com
About this study
Chronic pain after laparoscopic cholecystectomy (LC) is a common complication with an incidence ranging between 3-56%. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitization have been suggested to be part of the pathophysiology. So the purpose of this study is to determine whether Calot's Triangle Block (CTB) combined with patient controlled intravenous analgesia (PCIA) is superior to PCIA in reducing the incidence of chronic pain after LC.
Read the detailed description
Laparoscopic cholecystectomy (LC) is currently regarded as the gold standard treatment for symptomatic gallstone disease. Compared with open cholecystectomy, LC benefits include less postoperative pain, reduced analgesic consumption, and earlier discharge. However, besides the advantages mentioned above, there are exist complexity and diversity of the acute pain after LC, which consists of a somatic, a visceral and a referred pain component. Meanwhile, our team also found many LC patients experience visceral pain after surgery. According to epidemic research show that chronic pain after LC is a common complication with an incidence ranging between 3-56%. Several reports have indicated that early postoperative pain has been shown to be a significant risk factor of chronic pain. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitizationhave been suggested to be part of the pathophysiology. To reduce the incidence of chronic pain after LC, so we conduct the randomized controlled trial to investigate whether calot's triangle block combined with PCIA is superior to PCIA in reducing the incidence of chronic pain after LC.
This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, double-blind, controlled clinical trial guided by the standard of good clinical practice (GCP), and eligible participants are divided into two groups: group CTB and group PCIA, and primary assess the outcomes of the incidence of chronic pain after LC and the intensity of acute pain after LC.
Participants in group CTB will receive a single injection of ropivacaine in calot's triangle before surgical dissection combined with PCIA post-operatively.
Participants in group PCIA will receive a single injection in calot's triangle with normal saline before surgical dissection and PCIA post-operatively.
The primary outcome of this study is the incidence of chronic pain after LC.
The secondary outcomes of this study are acute post-operative pain, moderate-severe pain, rescue medication and adverse events associated with the post-operative analgesia.
This study will be conducted under the supervision of an independent auditor. Every week, the auditor checked the data of the participants the day after the surgery was conducted. Assessment of pain intensity and prognostic outcomes must be confirmed by the auditor in sample population. When there is disagreement between surgeon and anesthesiologists in evaluating the prognosis of patients, the auditor must solve this disagreement by discussion with evaluators. Data will be double-entered by two statisticians with limitation of access and locked during statistical analysis.
- Conditions
- Post-operative Pain, Gallstone Disease
- Being tested
- CTB group, PCIA group
- Keywords
- pain, calot's triangle, local block, analgesia, patient controlled intravenous analgesia
- Medical subject headings
- Pain, Postoperative, Cholelithiasis, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTB groupProcedure or surgery
CTB: A single injection of 1.0% 10ml ropivacaine by bile duct needle in calot's triangle when before surgical dissection.After surgery,participants in this group will also receive PCIA.
PCIA groupProcedure or surgery
The formula of the PCIA included tramadol 800 mg, flurbiprofen axetil 100mg with saline added up to a volume of 80 ml in total. The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
| Study group | Role | What they receive |
|---|---|---|
| CTB group | Experimental | Participants in this group will receive a single injection for calot's triangle block combined with PCIA post-operatively. CTB will be conducted by bile duct needle and 1.0% 10 ml ropivacaine will be injection in calot's triangle when before surgical dissection.Participants in this group will also receive PCIA after surgery,the regimens of PCIA are included tramadol 800 mg, flurbiprofenaxetil 100 mg with normal saline added up to a volume of 80 ml in total. Receives: Procedure: CTB group |
| PCIA group | Active comparator | Participants in this group will receive PCIA post-operatively (tramadol 800 mg and flurbiprofen axetil 100mg with normal saline added up to a volume of 80ml in total ) .The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h. Receives: Procedure: PCIA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic post-surgical pain
Chronic post-surgical pain intensity will be measured as more than 3 months by numerical rating scale (NRS) for pain
Measured: 3 months post-operatively
Secondary outcomes (5)
Acute pain post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
Measured: 2h,4h,6h,12h,24h, 48h post-operatively
Analgesic Rescue
The dosages of opioid or non-opioid analgesic rescue medications
Measured: from 2h to 48h post-operatively
Adverse events associated with post-operative analgesia
incomplete analgesia; nausea and vomiting; respiratory depression; over-sedation
Measured: from 2h to 48h post-operatively
moderate-severe pain
Pain intensity will be measured by numerical rating scale (NRS)
Measured: 3,6months postoperatively
chronic post-surgical pain
chronic post-surgical pain intensity will be measured by numerical rating scale (NRS) for pain
Measured: 6months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Su Min, MD, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300480
- Sponsor's protocol ID
- CYYYMZ-005
- Status last verified
- Nov 2014
- First submitted
- 19 Nov 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Blichfeldt-Eckhardt MR, Ording H, Andersen C, Licht PB, Toft P. Early visceral pain predicts chronic pain after laparoscopic cholecystectomy. Pain. 2014 Nov;155(11):2400-7. doi: 10.1016/j.pain.2014.09.019. Epub 2014 Sep 22.
PubMed 25250720Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 Feb 15;90(3):261-269. doi: 10.1016/S0304-3959(00)00406-1.
PubMed 11207398Lamberts MP, Lugtenberg M, Rovers MM, Roukema AJ, Drenth JP, Westert GP, van Laarhoven CJ. Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness. Surg Endosc. 2013 Mar;27(3):709-18. doi: 10.1007/s00464-012-2516-9. Epub 2012 Oct 6.
PubMed 23052498Macrae WA. Chronic pain after surgery. Br J Anaesth. 2001 Jul;87(1):88-98. doi: 10.1093/bja/87.1.88. No abstract available.
PubMed 11460816Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
PubMed 11020770Joris J, Thiry E, Paris P, Weerts J, Lamy M. Pain after laparoscopic cholecystectomy: characteristics and effect of intraperitoneal bupivacaine. Anesth Analg. 1995 Aug;81(2):379-84. doi: 10.1097/00000539-199508000-00029.
PubMed 7618731Bisgaard T, Rosenberg J, Kehlet H. From acute to chronic pain after laparoscopic cholecystectomy: a prospective follow-up analysis. Scand J Gastroenterol. 2005 Nov;40(11):1358-64. doi: 10.1080/00365520510023675.
PubMed 16334446Ingelmo PM, Bucciero M, Somaini M, Sahillioglu E, Garbagnati A, Charton A, Rossini V, Sacchi V, Scardilli M, Lometti A, Joshi GP, Fumagalli R, Diemunsch P. Intraperitoneal nebulization of ropivacaine for pain control after laparoscopic cholecystectomy: a double-blind, randomized, placebo-controlled trial. Br J Anaesth. 2013 May;110(5):800-6. doi: 10.1093/bja/aes495. Epub 2013 Jan 4.
PubMed 23293276Donatsky AM, Bjerrum F, Gogenur I. Intraperitoneal instillation of saline and local anesthesia for prevention of shoulder pain after laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2013 Jul;27(7):2283-92. doi: 10.1007/s00464-012-2760-z. Epub 2013 Jan 26.
PubMed 23355159Gurusamy KS, Nagendran M, Guerrini GP, Toon CD, Zinnuroglu M, Davidson BR. Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 13;(3):CD007337. doi: 10.1002/14651858.CD007337.pub3.
PubMed 24627292Desautels SG, Slivka A, Hutson WR, Chun A, Mitrani C, DiLorenzo C, Wald A. Postcholecystectomy pain syndrome: pathophysiology of abdominal pain in sphincter of Oddi type III. Gastroenterology. 1999 Apr;116(4):900-5. doi: 10.1016/s0016-5085(99)70073-9.
PubMed 10092312Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
PubMed 20961685Shaffer E. Acalculous biliary pain: new concepts for an old entity. Dig Liver Dis. 2003 Jul;35 Suppl 3:S20-5. doi: 10.1016/s1590-8658(03)00089-6.
PubMed 12974505SHAFIROFF BG, HINTON JW. Surgical anatomy of the choledochal nerves. Arch Surg (1920). 1950 May;60(5):944-952. doi: 10.1001/archsurg.1950.01250010967009. No abstract available.
PubMed 15411317Womack NA, Crider RL. The Persistence of Symptoms Following Cholecystectomy. Ann Surg. 1947 Jul;126(1):31-55. doi: 10.1097/00000658-194707000-00004. No abstract available.
PubMed 17858976
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Calot's Triangle Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Double-blind, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT02300480
- Acronym / sponsor ID
- CYYYMZ-005
- Conditions
- Post-operative Pain, Gallstone Disease
- Keywords
- pain, calot's triangle, local block, analgesia, patient controlled intravenous analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 25 Nov 2014 (estimated)
- 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.
Chronic pain after laparoscopic cholecystectomy (LC) is a common complication with an incidence ranging between 3-56%. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitization have been suggested to be part of the pathophysiology. So the purpose of this study is to determine whether Calot's Triangle Block (CTB) combined with patient controlled intravenous analgesia (PCIA) is superior to PCIA in reducing the incidence of chronic pain after LC.
Detailed description
Laparoscopic cholecystectomy (LC) is currently regarded as the gold standard treatment for symptomatic gallstone disease. Compared with open cholecystectomy, LC benefits include less postoperative pain, reduced analgesic consumption, and earlier discharge. However, besides the advantages mentioned above, there are exist complexity and diversity of the acute pain after LC, which consists of a somatic, a visceral and a referred pain component. Meanwhile, our team also found many LC patients experience visceral pain after surgery. According to epidemic research show that chronic pain after LC is a common complication with an incidence ranging between 3-56%. Several reports have indicated that early postoperative pain has been shown to be a significant risk factor of chronic pain. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitizationhave been suggested to be part of the pathophysiology. To reduce the incidence of chronic pain after LC, so we conduct the randomized controlled trial to investigate whether calot's triangle block combined with PCIA is superior to PCIA in reducing the incidence of chronic pain after LC.
This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, double-blind, controlled clinical trial guided by the standard of good clinical practice (GCP), and eligible participants are divided into two groups: group CTB and group PCIA, and primary assess the outcomes of the incidence of chronic pain after LC and the intensity of acute pain after LC.
Participants in group CTB will receive a single injection of ropivacaine in calot's triangle before surgical dissection combined with PCIA post-operatively.
Participants in group PCIA will receive a single injection in calot's triangle with normal saline before surgical dissection and PCIA post-operatively.
The primary outcome of this study is the incidence of chronic pain after LC.
The secondary outcomes of this study are acute post-operative pain, moderate-severe pain, rescue medication and adverse events associated with the post-operative analgesia.
This study will be conducted under the supervision of an independent auditor. Every week, the auditor checked the data of the participants the day after the surgery was conducted. Assessment of pain intensity and prognostic outcomes must be confirmed by the auditor in sample population. When there is disagreement between surgeon and anesthesiologists in evaluating the prognosis of patients, the auditor must solve this disagreement by discussion with evaluators. Data will be double-entered by two statisticians with limitation of access and locked during statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTB group | Experimental | Procedure: CTB groupParticipants in this group will receive a single injection for calot's triangle block combined with PCIA post-operatively. CTB will be conducted by bile duct needle and 1.0% 10 ml ropivacaine will be injection in calot's triangle when before surgical dissection.Participants in this group will also receive PCIA after surgery,the regimens of PCIA are included tramadol 800 mg, flurbiprofenaxetil 100 mg with normal saline added up to a volume of 80 ml in total. |
| PCIA group | Active comparator | Procedure: PCIA groupParticipants in this group will receive PCIA post-operatively (tramadol 800 mg and flurbiprofen axetil 100mg with normal saline added up to a volume of 80ml in total ) .The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men or woman over 18 the years and younger than 65 years old who will receive selective laparoscopic cholecystectomy.
Key exclusion criteria (15 listed)
- age below 18 years or over 65 years
- American Society of Anesthesiologists grade III or greater
- Diabetes
- chronic pain of any kind other than gallbladder disease
- allergic to local anesthetics
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 |
|---|---|---|
| CTB groupCTB: A single injection of 1.0% 10ml ropivacaine by bile duct needle in calot's triangle when before surgical dissection.After surgery,participants in this group will also receive PCIA. | Procedure or surgery | CTB group |
| PCIA groupThe formula of the PCIA included tramadol 800 mg, flurbiprofen axetil 100mg with saline added up to a volume of 80 ml in total. The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h. | Procedure or surgery | PCIA group |
Primary outcome
Chronic post-surgical pain
Time frame: 3 months post-operatively
Chronic post-surgical pain intensity will be measured as more than 3 months by numerical rating scale (NRS) for pain
5 secondary outcomes
Acute pain post-operatively
Time frame: 2h,4h,6h,12h,24h, 48h post-operatively
Analgesic Rescue
Time frame: from 2h to 48h post-operatively
Adverse events associated with post-operative analgesia
Time frame: from 2h to 48h post-operatively
moderate-severe pain
Time frame: 3,6months postoperatively
chronic post-surgical pain
Time frame: 6months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- Background: PubMed 25250720Blichfeldt-Eckhardt MR, Ording H, Andersen C, Licht PB, Toft P. Early visceral pain predicts chronic pain after laparoscopic cholecystectomy. Pain. 2014 Nov;155(11):2400-7. doi: 10.1016/j.pain.2014.09.019. Epub 2014 Sep 22.
- Background: PubMed 11207398Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 Feb 15;90(3):261-269. doi: 10.1016/S0304-3959(00)00406-1.
- Background: PubMed 23052498Lamberts MP, Lugtenberg M, Rovers MM, Roukema AJ, Drenth JP, Westert GP, van Laarhoven CJ. Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness. Surg Endosc. 2013 Mar;27(3):709-18. doi: 10.1007/s00464-012-2516-9. Epub 2012 Oct 6.
- Background: PubMed 11460816Macrae WA. Chronic pain after surgery. Br J Anaesth. 2001 Jul;87(1):88-98. doi: 10.1093/bja/87.1.88. No abstract available.
- Background: PubMed 11020770Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
- Background: PubMed 7618731Joris J, Thiry E, Paris P, Weerts J, Lamy M. Pain after laparoscopic cholecystectomy: characteristics and effect of intraperitoneal bupivacaine. Anesth Analg. 1995 Aug;81(2):379-84. doi: 10.1097/00000539-199508000-00029.
- Background: PubMed 16334446Bisgaard T, Rosenberg J, Kehlet H. From acute to chronic pain after laparoscopic cholecystectomy: a prospective follow-up analysis. Scand J Gastroenterol. 2005 Nov;40(11):1358-64. doi: 10.1080/00365520510023675.
- Background: PubMed 23293276Ingelmo PM, Bucciero M, Somaini M, Sahillioglu E, Garbagnati A, Charton A, Rossini V, Sacchi V, Scardilli M, Lometti A, Joshi GP, Fumagalli R, Diemunsch P. Intraperitoneal nebulization of ropivacaine for pain control after laparoscopic cholecystectomy: a double-blind, randomized, placebo-controlled trial. Br J Anaesth. 2013 May;110(5):800-6. doi: 10.1093/bja/aes495. Epub 2013 Jan 4.
- Background: PubMed 23355159Donatsky AM, Bjerrum F, Gogenur I. Intraperitoneal instillation of saline and local anesthesia for prevention of shoulder pain after laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2013 Jul;27(7):2283-92. doi: 10.1007/s00464-012-2760-z. Epub 2013 Jan 26.
- Background: PubMed 24627292Gurusamy KS, Nagendran M, Guerrini GP, Toon CD, Zinnuroglu M, Davidson BR. Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 13;(3):CD007337. doi: 10.1002/14651858.CD007337.pub3.
- Background: PubMed 10092312Desautels SG, Slivka A, Hutson WR, Chun A, Mitrani C, DiLorenzo C, Wald A. Postcholecystectomy pain syndrome: pathophysiology of abdominal pain in sphincter of Oddi type III. Gastroenterology. 1999 Apr;116(4):900-5. doi: 10.1016/s0016-5085(99)70073-9.
- Background: PubMed 20961685Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
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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.
Su Min, MD principal investigator
First Affiliated Hospital of Chongqing Medical University
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 CTB group and PCIA group in people with Post-operative Pain and Gallstone Disease, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 15 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: status not confirmed, as of the sponsor's last update on 26 Nov 2014. 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 China. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Zhang, Master (+86-23-89011061, zdcqmua420@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic post-surgical pain (time frame: 3 months post-operatively). 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 NCT02300480, which also lists 19 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 26 Nov 2014.