Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Abdominal surgeries are major surgical procedures that are performed at any teaching hospital. Pain control is major concern in the intra-operative as well as post-operative period in these patients. Optimal pain control in post-operative period is directly related to patient's recovery, shortens the patients' hospital stay and overall burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality. Different modalities for pain control are used in post-operative period. Opioids are mainstay of treatment in post-operative period but historically are associated with significant side effect profile like dependence, nausea, vomiting, respiratory depression, constipation and many others. Dexmedetomidine is centrally acting α-2 adrenoceptor agonist.
This randomized controlled trial was conducted at Department of Anesthesia, Sahiwal Teaching Hospital, Sahiwal. After institutional review board (IRB) approval, computer-generated random number table was used to randomize the patients to two groups, one group received Bupivacaine plus placebo and the other group received Bupivacaine plus dexmedetomidine. A total of 64 patients met the inclusion criteria and were enrolled in the study in a 1:1. Informed written consent was obtained from all the patients before enrolling them in the study. All patients underwent a pre-operative assessment on the day before surgery. Both groups received wound infiltration with studied drugs at the end of surgery. After surgery patients were shifted to post-surgical ward and assessed for pain using visual analogue scale (VAS) and data was collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variables were presented with mean ±SD. Comparison of quantitative variable between groups was done using independent sample t-test. Comparison of qualitative variable like (Opioid sparing effect, Bradycardia, Hypotension, Nausea, Vomiting) was presented with frequency and percentages. Data was stratified on the basis of gender and age. Post-stratification chi-square test was used to compare both groups for opioid sparing effect in each stratum with p-value ≤0.05 as significant.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine group | Experimental | Patients receiving Bupivacaine plus placebo for wound infiltration after abdominal surgery for pain control. |
|
| Bupivacaine plus Dexmedetomidine group | Experimental | Patients receiving Bupivacaine plus Dexmedetomidine for wound infiltration after abdominal surgery for pain control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivacaine wound infilteration | Drug | drug was given at the end of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of analgesia | Time from procedure to requirement of rescue analgesia | Every 30 mints for 4hrs than 2hrly for 24 hrs post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid sparing | Total amount of opioid consumtion in the first 24 post procedure. | Total dose of nalbuhine consumption in 1st 24 hrs after procedure |
| Blood pressure | Mean pressue will be measured |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| M. Shahid, FCPS | Sahiwal medical college sahiwal | Principal Investigator |
| A. Riaz, MD | Sahiwal medical college sahiwal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahiwal Medical College | Sahiwal | Punjab Province | 57000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24438599 | Result | Chen J, Zhou JQ, Chen ZF, Huang Y, Jiang H. Efficacy and safety of dexmedetomidine versus propofol for the sedation of tube-retention after oral maxillofacial surgery. J Oral Maxillofac Surg. 2014 Feb;72(2):285.e1-7. doi: 10.1016/j.joms.2013.10.006. Epub 2013 Oct 25. | |
| 23041302 | Result | Champaneria R, Shah L, Geoghegan J, Gupta JK, Daniels JP. Analgesic effectiveness of transversus abdominis plane blocks after hysterectomy: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2013 Jan;166(1):1-9. doi: 10.1016/j.ejogrb.2012.09.012. Epub 2012 Oct 4. |
Not provided
Not provided
We will not share individualized data, but the outcomes of the study will be shared in the form of manuscript.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2022 | Jul 12, 2024 |
Not provided
Not provided
Not provided
Not provided
Both patients and assessor were unaware of interventions
| Bupivacaine plus dexmedetomidine wound infilteration | Drug | drug was given at the end of surgery |
|
|
| Every 15 minutes intra operative and every 15 minutes for 24 hrs postoperatively |
| Hear rate | Heart rate will be measured | Every 15 minutes intraoperative and every 15 minutes postoperatively for 24 hrs |
| Neausea | Felling of nasueas | Every 30 minutes for 4 hrs then 2hrly for 24 hrs |
| Vomiting | Urge to vomit | Every 3 minutes for first 4 hrs then 2hrly for 24 hrs |
| 21851346 | Result | Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18. |
| 27307177 | Result | Brogi E, Kazan R, Cyr S, Giunta F, Hemmerling TM. Transversus abdominal plane block for postoperative analgesia: a systematic review and meta-analysis of randomized-controlled trials. Can J Anaesth. 2016 Oct;63(10):1184-1196. doi: 10.1007/s12630-016-0679-x. Epub 2016 Jun 15. |
| 22546966 | Result | Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb. |
| 24882606 | Result | Bhatia N, Arora S, Jyotsna W, Kaur G. Comparison of posterior and subcostal approaches to ultrasound-guided transverse abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy. J Clin Anesth. 2014 Jun;26(4):294-9. doi: 10.1016/j.jclinane.2013.11.023. Epub 2014 Jun 2. |
| 16436839 | Result | Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. doi: 10.1097/00000542-200602000-00005. |
| 27082959 | Result | Ayad S, Babazade R, Elsharkawy H, Nadar V, Lokhande C, Makarova N, Khanna R, Sessler DI, Turan A. Comparison of Transversus Abdominis Plane Infiltration with Liposomal Bupivacaine versus Continuous Epidural Analgesia versus Intravenous Opioid Analgesia. PLoS One. 2016 Apr 15;11(4):e0153675. doi: 10.1371/journal.pone.0153675. eCollection 2016. |
| 15680647 | Result | Ard JL Jr, Bekker AY, Doyle WK. Dexmedetomidine in awake craniotomy: a technical note. Surg Neurol. 2005 Feb;63(2):114-6; discussion 116-7. doi: 10.1016/j.surneu.2004.02.029. |
| 12145072 | Result | Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg. 2002 Aug;95(2):461-6, table of contents. doi: 10.1097/00000539-200208000-00042. |
| 28058142 | Result | Altuntas G, Akkaya OT, Ozkan D, Sayin MM, Balas S, Ozlu E. Comparison of Intraabdominal and Trocar Site Local Anaesthetic Infiltration on Postoperative Analgesia After Laparoscopic Cholecystectomy. Turk J Anaesthesiol Reanim. 2016 Dec;44(6):306-311. doi: 10.5152/TJAR.2016.75983. Epub 2016 Dec 1. |
| 22286518 | Result | Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531. |
| 23811424 | Result | Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001919 | Bradycardia |
| D007022 | Hypotension |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D012817 | Signs and Symptoms, Digestive |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided