Nctid:
NCT06616441
Payload:
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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."}, {"pmid"=>"33123690", "type"=>"BACKGROUND", "citation"=>"Cunningham 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."}, {"pmid"=>"16320034", "type"=>"BACKGROUND", "citation"=>"Haefeli 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."}, {"pmid"=>"35413905", "type"=>"BACKGROUND", "citation"=>"Adlan 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."}, {"pmid"=>"31517775", "type"=>"BACKGROUND", "citation"=>"Sao 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."}, {"pmid"=>"30699235", "type"=>"BACKGROUND", "citation"=>"Kaloo 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."}, {"pmid"=>"24965972", "type"=>"BACKGROUND", "citation"=>"Jimenez 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."}, {"pmid"=>"23706546", "type"=>"BACKGROUND", "citation"=>"Arden 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."}, {"pmid"=>"22819575", "type"=>"BACKGROUND", "citation"=>"Manjunath 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."}, {"pmid"=>"22763313", "type"=>"BACKGROUND", "citation"=>"Marks 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."}, {"pmid"=>"17653742", "type"=>"BACKGROUND", "citation"=>"Malhotra 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. Erratum In: Arch Gynecol Obstet. 2009 Apr;279(4):611. Riwari, Vimmi [corrected to Rewari, Vimi]."}, {"pmid"=>"16036193", "type"=>"BACKGROUND", "citation"=>"Chou 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."}, {"pmid"=>"15203590", "type"=>"BACKGROUND", "citation"=>"Buck 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."}]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nUnfortunately, 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.\n\nVisual 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.\n\nThere 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.\n\nBupivacaine, 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.\n\nHence 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.", "detailedDescription"=>"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.\n\nRandomization will be through opaque sealed envelopes.\n\nAfter signing their informed consents, the patients who are included in the study will be divided into two groups each group include (60) patients.\n\nGroup A: Patients that will receive intraoperative instillation of bupivacaine. Group B: (Control group) that will not receive the medication.\n\nThe patients in both groups will be subjected to:\n\nPre-operative:\n\nHistory taking (gynecological, obstetric, medical any drug reaction and surgical), general examination and abdominal examination.\n\nIntra-operative:\n\npremedication : 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\n\n1gm paracetamol IV as intraoperative analgesia which will not interfere with postoperative pain scoring.\n\nGroup (A) only will receive intra-peritoneal 40 ml bupivacaine 0.2%, after laparoscopic procedure before removing trocars."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "genderBased"=>true, "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Patients those are indicated for surgical laparoscopy, whatever the gynecological problem.\n2. Age between (18-50) years.\n3. Cooperative patient that can express pain and score it.\n\nExclusion Criteria:\n\n1. Non-cooperative patients that cannot express and score pain.\n2. Drug abusers due to altered pain threshold.\n3. Surgical laparoscopy indicated for oncological procedures.\n4. Any allergy or reaction to any of the derivatives of bupivacaine drug group.\n5. Any cardio-pulmonary condition."}, "identificationModule"=>{"nctId"=>"NCT06616441", "briefTitle"=>"The Effect of Intraperitoneal Instillation of Bupivacaine on Postoperative Pain After Surgical Laparoscopy", "organization"=>{"class"=>"OTHER", "fullName"=>"El Shatby University Hospital for Obstetrics and Gynecology"}, "officialTitle"=>"The Effect of Intraperitoneal Instillation of Bupivacaine on Postoperative Pain After Surgical Laparoscopy", "orgStudyIdInfo"=>{"id"=>"0107909"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Grouo A", "description"=>"Patients that will receive intraoperative instillation of bupivacaine.", "interventionNames"=>["Drug: Bupivacaine"]}, {"type"=>"NO_INTERVENTION", "label"=>"Group B", "description"=>"(Control group) that will not receive the medication."}], "interventions"=>[{"name"=>"Bupivacaine", "type"=>"DRUG", "description"=>"Group (A) only will receive intra-peritoneal 40 ml bupivacaine 0.2%, after laparoscopic procedure before removing trocars.", "armGroupLabels"=>["Grouo A"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Alexandria", "country"=>"Egypt", "facility"=>"Faculty of Medicine, University of Alexandria", "geoPoint"=>{"lat"=>31.21564, "lon"=>29.95527}}], "overallOfficials"=>[{"name"=>"Aly Hussein, Dr", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Alexandria University"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "CSR"], "ipdSharing"=>"YES"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"El Shatby University Hospital for Obstetrics and Gynecology", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"primary investigator", "investigatorFullName"=>"Aly Hussein", "investigatorAffiliation"=>"El Shatby University Hospital for Obstetrics and Gynecology"}}}}
