Different Maneuvers for Reducing Post-laparoscopic Pain

NCT04475809 | Completed

• 1 other identifier: 6251-1207-2020
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

• Laparoscopic surgeries are becoming more attractive because of early recovery. However, post-laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site
• Many strategies have been attempted, such as the use of nonsteroidal anti-inflammatory drugs; however, the effect is limited, and there are no reliable methods available yet.
• Recently, some techniques are introduced that can potentially alleviate various types of pain through different mechanisms in patients after laparoscopic surgery such as low-pressure pneumoperitoneum, intraperitoneal normal saline infusion, and pulmonary recruitment maneuvers.
• the investigators conduct this randomized controlled trial to evaluate the effectiveness of different strategies on reducing the intensity of post-laparoscopic shoulder and abdominal pain in patients undergoing laparoscopic gynecologic surgeries.

Conditions

Gynecologic Disease

Keywords

Pulmonary recruitment maneuvers; low-pressure pneumoperitoneum; laparoscopic Shoulder and Abdominal Pain; laparoscopic gynecologic surgery; intraperitoneal saline infusion

Outcome Measures

Primary Outcomes (1)

• changes in assessment of shoulder, abdominal and incisional pain

  will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.

  at 1, 2, 4, 6, 12, 24, 48,72,96 hours postoperatively

Secondary Outcomes (2)

• Time of first request of analgesia

  within 24 hour postoperative

• Total rescue analgesic requirement

  during the first postoperative 96 hours

Study Arms (4)

Group C

PLACEBO COMPARATOR

high intra-abdominal pressure

Procedure: group C

Group L

ACTIVE COMPARATOR

low intra-abdominal pressure

Procedure: Group L

Group LR

ACTIVE COMPARATOR

low intra-abdominal pressure with pulmonary recruitment maneuver group

Procedure: Group LR

Group LS

ACTIVE COMPARATOR

low intra-abdominal pressure with intraperitoneal saline infusion group

Procedure: Group LS

Interventions

group C PROCEDURE

laparoscopy will be performed with 14-16 mmHg intra-abdominal pressure. At the end of the procedure routine method for CO2 removal, passive exsufflation, will be used by applying gentle abdominal pressure to evacuate the residual gas through the port site.

Group C

Group L PROCEDURE

laparoscopy will be performed with 8-10 mmHg intra-abdominal pressure and routine passive exsufflation will be applied for CO2 removal at the end of the procedure.

Group L

Group LR PROCEDURE

the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure pulmonary recruitment maneuver (PRM) will be done; which consists of five manual pulmonary inflations at a maximum pressure of 40 cm H2O and the fifth will be held for 5 seconds. During this procedure, the surgeon is instructed to keep the port sleeve valve fully opened to allow the CO2 to escape the abdominal cavity.

Group LR

Group LS PROCEDURE

the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure, intraperitoneal normal saline (IPS) will be infused for removal of the intra-abdominal CO2; in which we fill the upper part of the abdominal cavity evenly and bilaterally with isotonic normal saline (15-20 mL/kg body weight)

Group LS

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance.
• BMI ≤35 kg/m2.
• ASA I and ASA II.
• Scheduled for elective laparoscopic gynecologic surgeries for benign lesions under general anesthesia.

You may not qualify if:

• Patients with pre-existing chronic pain disorders.
• Patients on opioid or sedative use.
• Psychological and mental disorders.
• Severe hypertensive, cardiac, hepatic and renal patients.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, zagazig university

Zagazig, Elsharqya, 44519, Egypt

Location

Related Publications (6)

• 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: 30699235 BACKGROUND

• Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.

  PMID: 22184293 BACKGROUND

• Yasir M, Mehta KS, Banday VH, Aiman A, Masood I, Iqbal B. Evaluation of post operative shoulder tip pain in low pressure versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy. Surgeon. 2012 Apr;10(2):71-4. doi: 10.1016/j.surge.2011.02.003. Epub 2011 Mar 21.

  PMID: 22385527 BACKGROUND

• Pergialiotis V, Vlachos DE, Kontzoglou K, Perrea D, Vlachos GD. Pulmonary recruitment maneuver to reduce pain after laparoscopy: a meta-analysis of randomized controlled trials. Surg Endosc. 2015 Aug;29(8):2101-8. doi: 10.1007/s00464-014-3934-7. Epub 2014 Nov 1.

  PMID: 25361653 BACKGROUND

• Davari-Tanha F, Samimi S, Khalaj Z, Bastanhagh E. Comparison of Intraperitoneal Normal Saline Infusion with Pulmonary Recruitment Maneuver in Reducing Shoulder and Upper Abdomen Pain Following Gynecologic Laparoscopic Procedures: A Randomized, Controlled, Triple-Blind Trial. Anesth Pain Med. 2019 Jun 2;9(3):e92444. doi: 10.5812/aapm.92444. eCollection 2019 Jun.

  PMID: 31497525 BACKGROUND

• Sharami SH, Sharami MB, Abdollahzadeh M, Keyvan A. Randomised clinical trial of the influence of pulmonary recruitment manoeuvre on reducing shoulder pain after laparoscopy. J Obstet Gynaecol. 2010;30(5):505-10. doi: 10.3109/01443611003802313.

  PMID: 20604657 BACKGROUND

MeSH Terms

Conditions

Genital Diseases, Female; Abdominal Pain

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) double-blinded ( patient and outcome assessors)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical intensive care

Model Details: The patients will be divided randomly by a computer-generated randomization table into two equal groups

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 17, 2020
• Study Start: July 13, 2020
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: planned after the completion of the study and publication
• Access Criteria: principal investigator

Locations

EG (1)