Intraperitoneal Local Anesthetic in Bariatric Surgery Study (iLABS Study)

NCT03175081 | Completed DMC

• 1 other identifier: NMRR-17-284-33857
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

Obesity is a metabolic disorder that has gradually become a prevalent public health problem and is becoming one of the leading causes of death and disability worldwide. The most efficacious therapy for morbid obesity today is bariatric surgery. Bariatric surgery increases life expectancy by correcting the comorbidities associated with obesity, improves the quality of life, and is associated with reduced morbidity and mortality. There is an increase application of laparoscopic procedures as it is considered to cause less pain than traditional open surgery, smaller incision, reduced blood loss and shorter postoperative stay, which cuts down on hospital cost. However, postoperative pain still exists causing unpleasant experience for the patient and at times causes a delayed discharge. Pain after bariatric surgery is a result of many mechanisms such as tissue injury, abdominal distention, local trauma of the stomach, chemical irritation of the peritoneum, and the pneumoperitoneum and this pain potentially can prolong hospital stay and lead to increased morbidity, and bariatric surgeons are striving to minimize the morbidity of current procedures to improve patient outcomes and this gave rise to the use of intraperitoneal local anesthetics (LA). It was found that the use of intraperitoneal LA in laparoscopic cholecystectomy is safe, and it results in a statistically significant reduction in early postoperative abdominal pain. Many studies were done to evaluate the efficacy of intraperitoneal LA in laparoscopic cholecystectomy, gynecologic procedures and appendectomy but to date there are limited studies done to evaluate the role of intraperitoneal LA in bariatric surgery. The aim of this study is to evaluate the effectiveness of intraperitoneal instillation of local ropivacaine on postoperative abdominal pain after laparoscopic sleeve gastrectomy (LSG). We hypothesized that the administration of intraperitoneal instillation of local ropivacaine would help reduce postoperative pain.

Conditions

Overweight and Obesity; Bariatric Surgery Candidate

Keywords

Intraperitoneal local anesthetic; Ropivacaine; Postoperative pain; Bariatric surgery; Sleeve gastrectomy

Outcome Measures

Primary Outcomes (6)

• 2 hours postoperative pain at rest

  Measured by visual analogue pain scale

  2 hours after surgery

• 4 hours postoperative pain at rest

  Measured by visual analogue pain scale

  4 hours after surgery

• 6 hours postoperative pain at rest

  Measured by visual analogue pain scale

  6 hours after surgery

• 8 hours postoperative pain at rest

  Measured by visual analogue pain scale

  8 hours after surgery

• 24 hours postoperative pain at rest

  Measured by visual analogue pain scale

  24 hours after surgery

• 48 hours postoperative pain at rest

  Measured by visual analogue pain scale

  48 hours after surgery

Secondary Outcomes (6)

• 2 hours postoperative pain at cough

  2 hours after surgery

• 4 hours postoperative pain at cough

  4 hours after surgery

• 6 hours postoperative pain at cough

  6 hours after surgery

• 8 hours postoperative pain at cough

  8 hours after surgery

• 24 hours postoperative pain at cough

  24 hours after surgery

Study Arms (2)

Test group

EXPERIMENTAL

Patients will undergo elective laparoscopic sleeve gastrectomy with ropivacaine diluted in normal saline injected along the stomach region at the end of the surgical procedure.

Drug: Ropivacaine

Control group

EXPERIMENTAL

Patients will undergo elective laparoscopic sleeve gastrectomy with only normal saline injected along the stomach region at the end of the surgical procedure.

Drug: Normal saline

Interventions

Ropivacaine DRUG

Patient undergo elective laparoscopic sleeve gastrectomy will receive 20mL of 150mg ropivacaine (0.75%) diluted in 180mL normal saline to be injected through a catheter along the greater curvature and left subdiaphragmatic region of the stomach at the end of the surgical procedure. After the surgery, the medical doctors or nurses in the ward that is not otherwise involved in this research will assess and record the pain score using visual analog scale (VAS) (0-10). The abdomen and shoulder tip pain intensity will be rated at two, four, six, eight, 24 and 48 hours postoperatively.

Also known as: Test group

Test group

Normal saline DRUG

Patient undergo elective laparoscopic sleeve gastrectomy will receive 200mL normal saline to be injected through a catheter along the greater curvature and left subdiaphragmatic region of the stomach at the end of the surgical procedure. After the surgery, the medical doctors or nurses in the ward that is not otherwise involved in this research will assess and record the pain score using visual analog scale (VAS) (0-10). The abdomen and shoulder tip pain intensity will be rated at two, four, six, eight, 24 and 48 hours postoperatively.

Also known as: Control group

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Patients age 18 years and above ii. Patients who can communicate in English or Malay iii. Patients undergoing elective laparoscopic sleeve gastrectomy iv. Able to give informed consent

You may not qualify if:

• i. Patients age below 18 years ii. Patients are allergic to ropivacaine or local anaesthetic iii. Inability to informed consent iv. American Society of Anesthesiologists Classification \> 3 v. Patients with chronic medical diseases (eg. Ischaemic heart disease, cardiac arrhythmias, cardiac failure) and chronic opioid treatment vi. Patients with previous foregut surgery including esophageal, gastric, liver, and pancreas resections

Sponsors & Collaborators

• Dr. Tikfu Gee: lead

Study Sites (2)

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

Hospital Serdang

Kajang, Selangor, 43400, Malaysia

Location

Related Publications (21)

• Sjostrom L. Bariatric surgery and reduction in morbidity and mortality: experiences from the SOS study. Int J Obes (Lond). 2008 Dec;32 Suppl 7:S93-7. doi: 10.1038/ijo.2008.244.

  PMID: 19136998 BACKGROUND

• Lee YC, Lee CK, Liew PL, Lin YC, Lee WJ. Evaluation of quality of life and impact of personality in Chinese obese patients following laparoscopic sleeve gastrectomy. Hepatogastroenterology. 2011 Jul-Aug;58(109):1248-51. doi: 10.5754/hge10619.

  PMID: 21937388 BACKGROUND

• Rosenthal RJ; International Sleeve Gastrectomy Expert Panel; Diaz AA, Arvidsson D, Baker RS, Basso N, Bellanger D, Boza C, El Mourad H, France M, Gagner M, Galvao-Neto M, Higa KD, Himpens J, Hutchinson CM, Jacobs M, Jorgensen JO, Jossart G, Lakdawala M, Nguyen NT, Nocca D, Prager G, Pomp A, Ramos AC, Rosenthal RJ, Shah S, Vix M, Wittgrove A, Zundel N. International Sleeve Gastrectomy Expert Panel Consensus Statement: best practice guidelines based on experience of >12,000 cases. Surg Obes Relat Dis. 2012 Jan-Feb;8(1):8-19. doi: 10.1016/j.soard.2011.10.019. Epub 2011 Nov 10.

  PMID: 22248433 BACKGROUND

• Dixon JB, le Roux CW, Rubino F, Zimmet P. Bariatric surgery for type 2 diabetes. Lancet. 2012 Jun 16;379(9833):2300-11. doi: 10.1016/S0140-6736(12)60401-2. Epub 2012 Jun 9.

  PMID: 22683132 BACKGROUND

• Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.

  PMID: 10718794 BACKGROUND

• Parikh M, Issa R, McCrillis A, Saunders JK, Ude-Welcome A, Gagner M. Surgical strategies that may decrease leak after laparoscopic sleeve gastrectomy: a systematic review and meta-analysis of 9991 cases. Ann Surg. 2013 Feb;257(2):231-7. doi: 10.1097/SLA.0b013e31826cc714.

  PMID: 23023201 BACKGROUND

• Pequignot A, Fuks D, Verhaeghe P, Dhahri A, Brehant O, Bartoli E, Delcenserie R, Yzet T, Regimbeau JM. Is there a place for pigtail drains in the management of gastric leaks after laparoscopic sleeve gastrectomy? Obes Surg. 2012 May;22(5):712-20. doi: 10.1007/s11695-012-0597-0.

  PMID: 22328096 BACKGROUND

• Kim TH, Kang H, Hong JH, Park JS, Baek CW, Kim JY, Jung YH, Kim HK. Intraperitoneal and intravenous lidocaine for effective pain relief after laparoscopic appendectomy: a prospective, randomized, double-blind, placebo-controlled study. Surg Endosc. 2011 Oct;25(10):3183-90. doi: 10.1007/s00464-011-1684-3. Epub 2011 Apr 13.

  PMID: 21487863 BACKGROUND

• Chazelet C, Verhaeghe P, Perterli R, Fennich S, Houdart R, Topart R, Tussiot J, Skawinski P, Seraille G, Catheline JM, Merabet M, Dehaye B, Pautot V, Juglard G, Sala JJ. [Longitudinal sleeve gastrectomy as a stand-alone bariatric procedure: Results of a multicenter retrospective study]. J Chir (Paris). 2009 Aug;146(4):368-72. doi: 10.1016/j.jchir.2009.08.021. Epub 2009 Sep 16. French.

  PMID: 19762021 BACKGROUND

• Louizos AA, Hadzilia SJ, Leandros E, Kouroukli IK, Georgiou LG, Bramis JP. Postoperative pain relief after laparoscopic cholecystectomy: a placebo-controlled double-blind randomized trial of preincisional infiltration and intraperitoneal instillation of levobupivacaine 0.25%. Surg Endosc. 2005 Nov;19(11):1503-6. doi: 10.1007/s00464-005-3002-4. Epub 2005 Oct 3.

  PMID: 16328673 BACKGROUND

• Elhakim M, Elkott M, Ali NM, Tahoun HM. Intraperitoneal lidocaine for postoperative pain after laparoscopy. Acta Anaesthesiol Scand. 2000 Mar;44(3):280-4. doi: 10.1034/j.1399-6576.2000.440310.x.

  PMID: 10714840 BACKGROUND

• Barczynski M, Konturek A, Herman RM. Superiority of preemptive analgesia with intraperitoneal instillation of bupivacaine before rather than after the creation of pneumoperitoneum for laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. Surg Endosc. 2006 Jul;20(7):1088-93. doi: 10.1007/s00464-005-0458-1. Epub 2006 May 13.

  PMID: 16703434 RESULT

• Lepner U, Goroshina J, Samarutel J. Postoperative pain relief after laparoscopic cholecystectomy: a randomised prospective double-blind clinical trial. Scand J Surg. 2003;92(2):121-4.

  PMID: 12841551 RESULT

• Khan MR, Raza R, Zafar SN, Shamim F, Raza SA, Pal KM, Zafar H, Alvi R, Chawla T, Azmi R. Intraperitoneal lignocaine (lidocaine) versus bupivacaine after laparoscopic cholecystectomy: results of a randomized controlled trial. J Surg Res. 2012 Dec;178(2):662-9. doi: 10.1016/j.jss.2012.06.005. Epub 2012 Jun 22.

  PMID: 22763212 RESULT

• 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.

  PMID: 17653742 RESULT

• Ceyhan T, Teksoz E, Gungor S, Goktolga U, Pabuccu R. Effect of bupivacaine after operative laparoscopic gynecologic procedures. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):326-9. doi: 10.1016/j.jmig.2005.05.003.

  PMID: 16036192 RESULT

• Jiranantarat V, Rushatamukayanunt W, Lert-akyamanee N, Sirijearanai R, Piromrat I, Suwannanonda P, Muangkasem J. Analgesic effect of intraperitoneal instillation of bupivacaine for postoperative laparoscopic cholecystectomy. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S897-903.

  PMID: 12452227 RESULT

• Park YH, Kang H, Woo YC, Park SG, Baek CW, Jung YH, Kim JY, Koo GH, Kim SD, Park JS. The effect of intraperitoneal ropivacaine on pain after laparoscopic colectomy: a prospective randomized controlled trial. J Surg Res. 2011 Nov;171(1):94-100. doi: 10.1016/j.jss.2010.03.024. Epub 2010 Apr 8.

  PMID: 20605604 RESULT

• Ruiz-Tovar J, Gonzalez J, Garcia A, Cruz C, Rivas S, Jimenez M, Ferrigni C, Duran M. Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery: a Prospective Randomized Clinical Trial. Obes Surg. 2016 Nov;26(11):2616-2621. doi: 10.1007/s11695-016-2142-z.

  PMID: 27007272 RESULT

• Lee IO, Kim SH, Kong MH, Lee MK, Kim NS, Choi YS, Lim SH. Pain after laparoscopic cholecystectomy: the effect and timing of incisional and intraperitoneal bupivacaine. Can J Anaesth. 2001 Jun;48(6):545-50. doi: 10.1007/BF03016830.

  PMID: 11444448 RESULT

• Symons JL, Kemmeter PR, Davis AT, Foote JA, Baker RS, Bettendorf MJ, Paulson JE. A double-blinded, prospective randomized controlled trial of intraperitoneal bupivacaine in laparoscopic Roux-en-Y gastric bypass. J Am Coll Surg. 2007 Mar;204(3):392-8. doi: 10.1016/j.jamcollsurg.2006.12.013.

  PMID: 17324772 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Pain, Postoperative

Interventions

Ropivacaine; Saline Solution; Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Lim Shu Yu, MS

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior lecturer/ consultant

Model Details: The study will involve two groups with equal allocation of patients in the test group (local anaesthesia) and control group (normal saline) by randomization. All patients who agree to participate in this study will be randomized into one of the study groups.

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 5, 2017
• Study Start: April 27, 2017
• Primary Completion: February 27, 2018
• Study Completion: April 27, 2018
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)