Comparing Opioids Vs NSAIDs for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair

NCT06608056 | Completed

• 1 other identifier: SGR-2021-137-2499-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To control post-operative pain, multiple drugs are available, and in the western countries opioids are preferred. However, they have their own side effects, and so to reduce their dependence, multiple adjuncts are used. We compared the use of opioids vs just non steroidal anti-inflammatory drugs on post-operative pain control following inguinal hernia surgery

Conditions

Inguinal Hernia Unilateral; Pain Management

Keywords

Lichtenstein repair; ketorolac; tramadol; opioid; visual analogue score; non-steroidal anti-inflammatory drugs

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale - pain score

  Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain).

  2-, 6-, 12-, 24-hours following surgery

Secondary Outcomes (7)

• Flatus

  within 24 hours following surgery

• nausea/vomiting

  within 24 hours following surgery

• Time to ambulation

  within 24 hours following surgery

• rescue analgesia

  within 24 hours following surgery

• Mean arterial pressure

  2-, 6-, 12-, 24-hours following surgery

Study Arms (2)

Tramadol

EXPERIMENTAL

Patients received injection tramadol 50 mg intravenously every 8 hourly following surgery

Drug: Pain management after surgery

Ketorolac

EXPERIMENTAL

Patients received injection tramadol 30 mg intravenously every 8 hourly following surgery

Drug: Pain management after surgery

Interventions

Pain management after surgery DRUG

Patients in Group A received injection tramadol 50mg intravenously every 8 hours following surgery. Patients in Group B received injection ketorolac 30mg intravenously every 8 hours following surgery.

Ketorolac; Tramadol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective primary unilateral open inguinal hernia repair under spinal anesthesia - Lichtenstein repair with prolene mesh
• ASA I or II
• Ages 18 - 65

You may not qualify if:

• Patient on chronic pain meds
• Patient receiving analgesics 24hrs prior to surgery
• Incarcerated or strangulated hernia or recurrent hernia
• BMI \>40
• Allergic to medications being tested in this study

Sponsors & Collaborators

• Pakistan Air Force (PAF) Hospital Islamabad: lead

Study Sites (1)

Pakistan Air Force Hospital

Islamabad, Capital Territory, 44000, Pakistan

Location

Related Publications (16)

• Bugada D, Lavand'homme P, Ambrosoli AL, Klersy C, Braschi A, Fanelli G, Saccani Jotti GM, Allegri M; SIMPAR group. Effect of postoperative analgesia on acute and persistent postherniotomy pain: a randomized study. J Clin Anesth. 2015 Dec;27(8):658-64. doi: 10.1016/j.jclinane.2015.06.008. Epub 2015 Aug 30.

  PMID: 26329661 BACKGROUND

• Zende, A.M. and R.R. Bhosale, Comparison of postoperative analgesic efficacy and safety of parecoxib and ketorolac in patients of inguinal hernia. International Journal of Basic and Clinical Pharmacology, 2013. 2(4): p. 414-20.

  BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.

  PMID: 21965355 BACKGROUND

• Pavy TJ, Paech MJ, Evans SF. The effect of intravenous ketorolac on opioid requirement and pain after cesarean delivery. Anesth Analg. 2001 Apr;92(4):1010-4. doi: 10.1097/00000539-200104000-00038.

  PMID: 11273941 BACKGROUND

• Chen JY, Wu GJ, Mok MS, Chou YH, Sun WZ, Chen PL, Chan WS, Yien HW, Wen YR. Effect of adding ketorolac to intravenous morphine patient-controlled analgesia on bowel function in colorectal surgery patients--a prospective, randomized, double-blind study. Acta Anaesthesiol Scand. 2005 Apr;49(4):546-51. doi: 10.1111/j.1399-6576.2005.00674.x.

  PMID: 15777304 BACKGROUND

• National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse; Phillips JK, Ford MA, Bonnie RJ, editors. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington (DC): National Academies Press (US); 2017 Jul 13. Available from http://www.ncbi.nlm.nih.gov/books/NBK458660/

  PMID: 29023083 BACKGROUND

• Goettsch WG, Sukel MP, van der Peet DL, van Riemsdijk MM, Herings RM. In-hospital use of opioids increases rate of coded postoperative paralytic ileus. Pharmacoepidemiol Drug Saf. 2007 Jun;16(6):668-74. doi: 10.1002/pds.1338.

  PMID: 17072916 BACKGROUND

• Barletta JF, Asgeirsson T, Senagore AJ. Influence of intravenous opioid dose on postoperative ileus. Ann Pharmacother. 2011 Jul;45(7-8):916-23. doi: 10.1345/aph.1Q041. Epub 2011 Jul 5.

  PMID: 21730280 BACKGROUND

• Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.

  PMID: 24436674 BACKGROUND

• Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.

  PMID: 11460814 BACKGROUND

• Carr DB, Goudas LC. Acute pain. Lancet. 1999 Jun 12;353(9169):2051-8. doi: 10.1016/S0140-6736(99)03313-9.

  PMID: 10376632 BACKGROUND

• Mulita F, Parchas N, Solou K, Tchabashvili L, Gatomati F, Iliopoulos F, Maroulis I. Postoperative Pain Scores After Open Inguinal Hernia Repair: Comparison of Three Postoperative Analgesic Regimens. Med Arch. 2020 Oct;74(5):355-358. doi: 10.5455/medarh.2020.74.355-358.

  PMID: 33424089 BACKGROUND

• Burton, V. and P. A.J., Comparison of open and laparoscopic inguinal hernia repair. Mini-invasive Surgery, 2021. 5(26).

  BACKGROUND

• Fitzgibbons RJ Jr, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013 Sep;258(3):508-15. doi: 10.1097/SLA.0b013e3182a19725.

  PMID: 24022443 BACKGROUND

• Hammoud, M. and J. Gerken, Inguinal Hernia, in StatPearls. 2022: Treasure Island (FL).

  BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduate resident, Principle Investigator, Department of General Surgery

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: January 1, 2024
• Primary Completion: June 28, 2024
• Study Completion: June 30, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)